{"site":"Oxytocin Bio","url":"https://oxytocinbio.com","format":"evidence-manifest/v1","claim_count":98,"claims":[{"id":"clm-001","text":"Oxytocin is a cyclic nonapeptide with sequence Cys-Tyr-Ile-Gln-Asn-Cys-Pro-Leu-Gly-NH2 closed by a 1-6 disulfide bridge, molecular formula C43H66N12O12S2, molecular weight 1007.19, CAS 50-56-6.","source_url":"https://pubchem.ncbi.nlm.nih.gov/compound/439302","grade":"chemical-reference","grade_label":"Chemical reference","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/entity","https://oxytocinbio.com/faq","https://oxytocinbio.com/comparison"]},{"id":"clm-002","text":"The FDA label describes Pitocin as a nonapeptide found in pituitary extracts from mammals.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph"]},{"id":"clm-003","text":"FDA classes the oxytocin drug product under the established pharmacologic class Oxytocic, with the physiologic effect increased uterine smooth muscle contraction or tone.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/entity"]},{"id":"clm-010","text":"Pitocin, oxytocin injection USP, is an FDA-approved prescription drug under NDA 018261, standardized to 10 USP units per mL.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018261","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/entity","https://oxytocinbio.com/faq","https://oxytocinbio.com/comparison"]},{"id":"clm-011","text":"The Pitocin label indicates it for medically indicated induction or stimulation of labor, as adjunctive therapy in incomplete or inevitable abortion, and postpartum to produce uterine contractions and control bleeding or hemorrhage; it states Pitocin is not indicated for elective induction of labor, and that for induction or augmentation it must be given only intravenously with adequate medical supervision in a hospital.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/faq","https://oxytocinbio.com/comparison"]},{"id":"clm-012","text":"No FDA-approved intranasal oxytocin product exists; a query of the FDA labeled-drug database for substance oxytocin with a nasal route returns no matches.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=012285","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/entity","https://oxytocinbio.com","https://oxytocinbio.com/faq","https://oxytocinbio.com/comparison"]},{"id":"clm-013","text":"The approved nasal product, Syntocinon nasal solution, NDA 012285, contained oxytocin at 40 USP units per mL.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=012285","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/tool-data","https://oxytocinbio.com/comparison"]},{"id":"clm-014","text":"On August 7, 1997 FDA published a notice withdrawing approval of NDA 12-285, Syntocinon oxytocin nasal solution nasal spray, held by Novartis, effective September 8, 1997.","source_url":"https://www.federalregister.gov/documents/1997/08/07/97-20871/sterling-drug-inc-et-al-withdrawal-of-approval-of-28-new-drug-applications-9-abbreviated-antibiotic","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/entity","https://oxytocinbio.com/faq","https://oxytocinbio.com/comparison"]},{"id":"clm-015","text":"The 1997 withdrawal was requested by the application holders because the products were no longer marketed, and oxytocin nasal solution does not appear in 21 CFR 216.24, the list of drug products withdrawn or removed for reasons of safety or effectiveness.","source_url":"https://www.federalregister.gov/documents/1997/08/07/97-20871/sterling-drug-inc-et-al-withdrawal-of-approval-of-28-new-drug-applications-9-abbreviated-antibiotic","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/faq","https://oxytocinbio.com/limits_text"]},{"id":"clm-016","text":"Compounded nasal oxytocin preparations are not reviewed by FDA for safety, effectiveness or manufacturing quality before they are dispensed, and no public standard governs their strength, preservative or delivered dose per actuation.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=012285","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/faq","https://oxytocinbio.com/comparison","https://oxytocinbio.com/copy"]},{"id":"clm-020","text":"Intranasal oxytocin has a large human research literature spanning autism, social cognition, schizophrenia, eating behavior, weight, trust and sexual function, unlike most compounds sold in the wellness market.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC7815514/","grade":"systematic-review","grade_label":"Systematic review","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com"]},{"id":"clm-021","text":"A 2016 analysis of the statistical features of the intranasal oxytocin literature concluded that these studies are generally underpowered and that there is a high probability most published intranasal oxytocin findings do not represent true effects.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC4690817/","grade":"systematic-review","grade_label":"Systematic review","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/limits_text","https://oxytocinbio.com/faq","https://oxytocinbio.com"]},{"id":"clm-022","text":"One laboratory published its own file drawer, reporting that from eight studies in 453 subjects between 2009 and 2014 only five publications emerged and only one of those reported a null finding.","source_url":"https://europepmc.org/article/MED/26991328","grade":"systematic-review","grade_label":"Systematic review","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/limits_text","https://oxytocinbio.com/faq"]},{"id":"clm-023","text":"A 2016 commentary in Biological Psychiatry states that very little of the amount applied intranasally appears to reach cerebrospinal fluid while peripheral concentrations rise to supraphysiologic levels with likely effects on the gastrointestinal tract, heart and reproductive tract, and warns that the wish to believe in the effectiveness of intranasal oxytocin is widespread and needs to be guarded against.","source_url":"https://europepmc.org/article/MED/26049207","grade":"systematic-review","grade_label":"Systematic review","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/limits_text"]},{"id":"clm-024","text":"A 2012 critical review attributed inconsistent nasal oxytocin results in part to variability across experiments in controlling extraneous confounds, differing methods of assessing cognition, and a focus on group-based outcomes.","source_url":"https://europepmc.org/article/MED/22265852","grade":"systematic-review","grade_label":"Systematic review","used_on":["https://oxytocinbio.com/monograph"]},{"id":"clm-030","text":"Oxytocin promotes uterine contraction by increasing intracellular calcium, acting on specific myometrial receptors whose concentration increases greatly during pregnancy and peaks in early labor at term.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph"]},{"id":"clm-031","text":"The FDA label states that oxytocin even in pure form has inherent pressor and antidiuretic properties that may become manifest when large doses are administered, attributing this to its structural closeness to vasopressin.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph"]},{"id":"clm-032","text":"Oxytocin receptors are expressed beyond the uterus, including in brain regions involved in social and emotional processing, which is the stated biological rationale for testing oxytocin in psychiatric conditions.","source_url":"https://europepmc.org/article/MED/29897293","grade":"systematic-review","grade_label":"Systematic review","used_on":["https://oxytocinbio.com/monograph"]},{"id":"clm-040","text":"A 24-week placebo-controlled phase 2 trial in 290 children and adolescents aged 3 to 17 with autism spectrum disorder, at a total target dose of 48 IU daily intranasally, found no significant difference from placebo on its primary outcome, with least-squares mean change on the ABC modified Social Withdrawal subscale of -3.7 for oxytocin and -3.5 for placebo, a difference of -0.2 (95% CI -1.5 to 1.0), P = 0.61.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC9701092/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com","https://oxytocinbio.com/faq","https://oxytocinbio.com/decision_aid","https://oxytocinbio.com/comparison"]},{"id":"clm-041","text":"In that trial the incidence and severity of adverse events were similar in the oxytocin and placebo groups.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC9701092/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/studies","https://oxytocinbio.com/monograph"]},{"id":"clm-042","text":"A multicenter randomized parallel-group trial in Japan enrolled 106 adults with autism spectrum disorder and analyzed 103, giving 48 IU per day intranasally for six weeks, and found no between-group difference on its primary endpoint of ADOS reciprocity, effect size -0.08 (95% CI -0.46 to 0.31), P = 0.69, while plasma oxytocin confirmed exposure.","source_url":"https://europepmc.org/article/MED/29955161","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq","https://oxytocinbio.com/decision_aid"]},{"id":"clm-043","text":"In that trial two secondary endpoints favored oxytocin, ADOS repetitive behavior (effect size 0.44, 95% CI 0.05 to 0.83, P = 0.026) and duration of gaze fixation on socially relevant regions (effect size 0.55, 95% CI 0.10 to 1.0, P = 0.018), and the authors concluded they cannot recommend continuous intranasal oxytocin at that dose and duration for core social symptoms.","source_url":"https://europepmc.org/article/MED/29955161","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/studies","https://oxytocinbio.com/monograph"]},{"id":"clm-044","text":"A randomized placebo-controlled trial with a three-week placebo lead-in gave 87 children aged 3 to 12 either 16 IU twice daily (32 IU per day) or placebo for twelve weeks and found no effect on the primary caregiver-rated Social Responsiveness Scale (P = 0.686), no benefit on the clinician-rated CGI-S or any secondary measure, and more adverse side effects reported in the placebo group.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC9607840/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq","https://oxytocinbio.com/decision_aid"]},{"id":"clm-045","text":"A crossover multicenter trial of TTA-121, a reformulated nasal oxytocin spray, found an inverted U-shaped dose-response curve peaking at 6 units per day across doses of 3, 6, 10 and 20 units per day, with the primary ADOS reciprocity endpoint not reaching significance in the full analysis set (P = 0.118) and reaching it only in the per-protocol set (P = 0.012), and no secondary outcome significantly improved in the full analysis set.","source_url":"https://europepmc.org/article/MED/35067719","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/studies","https://oxytocinbio.com/monograph","https://oxytocinbio.com/decision_aid"]},{"id":"clm-046","text":"TTA-121 was developed with enhanced bioavailability reported as 3.6 times that of Syntocinon spray, as assessed by area under the concentration-time curve in rabbit brains.","source_url":"https://europepmc.org/article/MED/35067719","grade":"animal-pk","grade_label":"Animal PK","used_on":["https://oxytocinbio.com/monograph"]},{"id":"clm-047","text":"A 2021 multilevel meta-analysis of 28 studies in 726 people with autism spectrum disorder reported beneficial effects on social functioning but not on non-social symptoms, and its inclusion criteria admitted single-arm, non-randomized and uncontrolled studies alongside randomized placebo-controlled trials.","source_url":"https://europepmc.org/article/MED/33400920","grade":"meta-analysis","grade_label":"Meta-analysis","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/decision_aid"]},{"id":"clm-060","text":"A meta-analysis of 17 randomized controlled trials in 466 people with neurodevelopmental disorders found no significant effect of intranasal oxytocin on emotion recognition (Hedges g = 0.08), a moderate but non-significant effect on empathy (g = 0.49) and a small significant effect on theory of mind (g = 0.21), with no moderation by diagnosis, age, dose or dosing frequency, and concluded the promise of intranasal oxytocin should be considered tentative.","source_url":"https://europepmc.org/article/MED/29032324","grade":"meta-analysis","grade_label":"Meta-analysis","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies"]},{"id":"clm-061","text":"A meta-analysis of 33 studies found that a single dose of intranasal oxytocin significantly improved recognition of basic emotions, particularly fear, and increased expression of positive emotions among healthy individuals, but did not significantly influence interpretation or expression of emotions among clinical populations.","source_url":"https://europepmc.org/article/MED/28467893","grade":"meta-analysis","grade_label":"Meta-analysis","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/decision_aid"]},{"id":"clm-062","text":"A 2005 study in Nature reported that intranasal oxytocin caused a substantial increase in trust in an investment game and that the effect was specific to social risk rather than a general increase in readiness to bear risks.","source_url":"https://europepmc.org/article/MED/15931222","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq","https://oxytocinbio.com/decision_aid"]},{"id":"clm-063","text":"A 2020 registered replication in 321 participants, powered above 95%, found no effect of oxytocin on trusting behavior in the minimal-social-contact condition that matched the original design, with an exploratory post hoc suggestion of an effect in low-trust individuals in a no-contact condition that the authors said requires confirmation.","source_url":"https://europepmc.org/article/MED/32514040","grade":"registered-replication","grade_label":"Registered replication","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq","https://oxytocinbio.com/limits_text","https://oxytocinbio.com/decision_aid"]},{"id":"clm-064","text":"A 2026 registered report replicated the trust experiment in 211 participants and pooled with the earlier replication for a total of 532, finding no evidence that intranasal oxytocin increases trusting behavior, with equivalence testing in the pooled dataset indicating the effect lies within a minimal range of effects.","source_url":"https://europepmc.org/article/MED/41880977","grade":"registered-replication","grade_label":"Registered replication","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com","https://oxytocinbio.com/faq","https://oxytocinbio.com/limits_text","https://oxytocinbio.com/decision_aid","https://oxytocinbio.com/comparison"]},{"id":"clm-065","text":"A 2026 high-powered preregistered study in 359 men selected for low dispositional trust reported that oxytocin increased trusting behavior by roughly 15%, rising to a 16.9% increase in a pooled analysis including a prior sample of 219 low-trusting individuals.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13462352/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/decision_aid"]},{"id":"clm-066","text":"A randomized controlled trial found no main effects of intranasal oxytocin or vasopressin across a battery of social cognitive and behavioral paradigms, and equivalence and Bayesian testing indicated that 47% to 83% of the results had enough sensitivity to detect the absence of a main effect.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC6687062/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies"]},{"id":"clm-067","text":"Across five double-blind placebo-controlled experiments, intranasal oxytocin created intergroup bias by motivating in-group favoritism and, to a lesser extent, out-group derogation, which the authors describe as oxytocin promoting human ethnocentrism.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC3029708/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq","https://oxytocinbio.com"]},{"id":"clm-068","text":"In a double-blind placebo-controlled within-subject game of chance in 56 participants, oxytocin increased envy ratings when the participant gained less than another player and increased gloating ratings when the participant gained more.","source_url":"https://europepmc.org/article/MED/19640508","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq"]},{"id":"clm-069","text":"A widely cited framework proposes that the social effects of oxytocin in humans are often weak or inconsistent and are constrained by features of the situation and of the individual, rather than being uniformly prosocial.","source_url":"https://europepmc.org/article/MED/21696997","grade":"systematic-review","grade_label":"Systematic review","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/faq"]},{"id":"clm-070","text":"A randomized double-blind placebo-controlled trial in 61 adults with obesity, given 24 IU intranasally four times daily for eight weeks, found no difference in body weight change from baseline to week 8 between oxytocin and placebo (0.20 versus 0.26 kg, P = 0.934).","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11427243/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com","https://oxytocinbio.com/faq","https://oxytocinbio.com/decision_aid","https://oxytocinbio.com/comparison"]},{"id":"clm-071","text":"In that trial oxytocin was not associated with beneficial effects on total fat mass, abdominal visceral adipose tissue, liver fat fraction or resting energy expenditure, while it did reduce caloric intake at an experimental test meal by 152.0 kcal (95% CI -302.3 to -1.7) relative to placebo.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11427243/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq","https://oxytocinbio.com/decision_aid"]},{"id":"clm-072","text":"Single doses of 24 IU intranasal oxytocin reduced caloric intake at a test meal in men in a crossover study, and a separate crossover study found the effect on hunger-driven intake was marked in 18 obese men but not in 20 normal-weight men, with snack consumption reduced in both groups and energy expenditure generally unaffected.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC4414748/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq","https://oxytocinbio.com/decision_aid"]},{"id":"clm-073","text":"In that comparison, hypothalamic-pituitary-adrenal axis secretion and the postprandial rise in plasma glucose were blunted by oxytocin in both obese and normal-weight groups.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC5116063/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/studies"]},{"id":"clm-074","text":"A meta-analysis of 12 controlled trials covering 266 non-psychiatric and 157 psychiatric participants found single-dose intranasal oxytocin significantly reduced food intake in non-psychiatric subjects (SMD -0.66, 95% CI -1.18 to -0.14) but not in anorexia nervosa, bulimia and binge eating disorder, or schizophrenia, and found no effect on food craving or hunger and no effect on anxiety or stress in any subgroup.","source_url":"https://europepmc.org/article/MED/34600216","grade":"meta-analysis","grade_label":"Meta-analysis","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/decision_aid"]},{"id":"clm-075","text":"A double-blind placebo-controlled pilot trial in 21 older adults with sarcopenic obesity, using 24 IU intranasally four times daily for eight weeks, reported improved lean muscle mass and lower LDL cholesterol.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC8567747/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies"]},{"id":"clm-076","text":"An analysis from the eight-week obesity trial reported stability of reproductive hormones with prolonged intranasal oxytocin in adults with obesity.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13078695/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies"]},{"id":"clm-080","text":"A 22-week randomized double-blind placebo-controlled crossover trial in 30 premenopausal and postmenopausal women with sexual dysfunction, self-administering 32 IU intranasally within 50 minutes before intercourse for eight weeks per arm, found no statistically significant treatment, sequence or interaction effect.","source_url":"https://europepmc.org/article/MED/26151620","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq","https://oxytocinbio.com/decision_aid","https://oxytocinbio.com/comparison"]},{"id":"clm-081","text":"In that trial the Female Sexual Function Index increased by 26% after oxytocin and 31% after placebo.","source_url":"https://europepmc.org/article/MED/26151620","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq","https://oxytocinbio.com/decision_aid","https://oxytocinbio.com/comparison"]},{"id":"clm-082","text":"In a naturalistic placebo-controlled study of 29 heterosexual couples, 24 IU intranasal oxytocin did not alter classical parameters of sexual function such as sexual drive, arousal, penile erection or lubrication, while secondary self-report measures around the orgasmic and post-orgasmic interval shifted at small to moderate effect sizes, more pronounced in men.","source_url":"https://europepmc.org/article/MED/24503174","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq","https://oxytocinbio.com/comparison"]},{"id":"clm-083","text":"An open prospective cohort of the male partners of women in that crossover trial found male sexual life quality improved both when the female partner used oxytocin and when she used placebo, and male desire and arousal remained stable throughout.","source_url":"https://europepmc.org/article/MED/28189292","grade":"human-obs","grade_label":"Human observational","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies"]},{"id":"clm-084","text":"A randomized double-blind placebo-controlled trial in 80 couples combining twice-daily intranasal oxytocin with a structured partner-appreciation task reported improved dermatological wound healing in the combined condition, but the authors state the effect was not consistently robust in sensitivity analyses.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12613093/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies"]},{"id":"clm-090","text":"A randomized double-blind placebo-controlled trial of 24 IU intranasal oxytocin as an adjunct to exposure therapy in 25 participants with social anxiety disorder improved self-appraisals of appearance and speech performance across sessions but did not improve overall treatment outcome, with similar symptom reduction on oxytocin and placebo across severity, dysfunctional cognition and life-impairment measures.","source_url":"https://europepmc.org/article/MED/19246160","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies"]},{"id":"clm-091","text":"A meta-analysis of 10 double-blind randomized placebo-controlled trials in 344 people with schizophrenia, using adjunctive intranasal oxytocin at 40 to 80 IU per day for 2 to 16 weeks, found no significant difference from placebo in total psychopathology (SMD -0.08, 95% CI -0.53 to 0.37, P = 0.74) or in positive, negative and general symptom scores, with only the 80 IU per day subgroup showing superiority.","source_url":"https://europepmc.org/article/MED/30573406","grade":"meta-analysis","grade_label":"Meta-analysis","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies"]},{"id":"clm-092","text":"A systematic review, meta-analysis and dose-response meta-analysis of nine randomized clinical trials found no significant effect of intranasal oxytocin on negative symptoms of schizophrenia overall, and a beneficial effect at higher doses that disappeared after excluding one outlier study.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC8378078/","grade":"meta-analysis","grade_label":"Meta-analysis","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies"]},{"id":"clm-093","text":"An eight-week randomized double-blind placebo-controlled trial in 23 children and adolescents with Prader-Willi syndrome found hyperphagia and repetitive behaviors decreased over time in the placebo group and not in the oxytocin group, with total Hyperphagia Questionnaire score falling an average 1.81 points per week more on placebo.","source_url":"https://europepmc.org/article/MED/33190843","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies"]},{"id":"clm-094","text":"A double-blind randomized placebo-controlled in-lab polysomnography study found 40 IU intranasal oxytocin at night decreased the duration of obstructive events and the associated oxygen desaturations and bradycardias in obstructive sleep apnea patients, increased respiratory rate during non-obstructive periods, and produced no significant changes in sleep architecture and no reported adverse effects.","source_url":"https://europepmc.org/article/MED/32862007","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/decision_aid"]},{"id":"clm-095","text":"A randomised double blind trial of oxytocin nasal spray in 51 mothers expressing breast milk for preterm infants found total milk production did not differ from placebo, and most mothers believed they were receiving the active spray, which the authors describe as a significant placebo effect.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC2672698/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies"]},{"id":"clm-100","text":"A population pharmacokinetic study using a liquid chromatography tandem mass spectrometry assay measured nasal oxytocin bioavailability at 0.7% after a 100 microgram intranasal dose in healthy adult men and nonpregnant women.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12106900/","grade":"human-pk","grade_label":"Human PK","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com","https://oxytocinbio.com/faq","https://oxytocinbio.com/limits_text","https://oxytocinbio.com/decision_aid","https://oxytocinbio.com/comparison"]},{"id":"clm-101","text":"In that study the intranasal two-compartment model was characterised by substantial subject-to-subject variability, with 9% median bias and 47% median inaccuracy, against 0% bias and 18% median inaccuracy for intravenous dosing.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12106900/","grade":"human-pk","grade_label":"Human PK","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/limits_text","https://oxytocinbio.com/comparison"]},{"id":"clm-102","text":"In that study oxytocin samples assayed with mass spectrometry were systematically higher than simultaneous samples assayed with enzyme-linked immunosorbent assay, and the authors attribute past inconsistency partly to antibody-based assays lacking specificity.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12106900/","grade":"human-pk","grade_label":"Human PK","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies"]},{"id":"clm-103","text":"In 15 people receiving 24 IU intranasal oxytocin or placebo with paired sampling, oxytocin rose significantly in both plasma and cerebrospinal fluid, plasma peaked at 15 minutes and decreased after 75 minutes while cerebrospinal fluid took up to 75 minutes to reach a significant level, and there was no correlation between the two (r below 0.10).","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC3853684/","grade":"human-pk","grade_label":"Human PK","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq","https://oxytocinbio.com/limits_text","https://oxytocinbio.com/decision_aid"]},{"id":"clm-104","text":"A study contrasting a standard nasal spray, a nebuliser and intravenous administration found that oxytocin-induced decreases in amygdala perfusion were explained entirely by increases in systemic circulation following both intranasal and intravenous administration, while the same authors also report robust evidence confirming the validity of the intranasal route to target specific brain regions.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC7054359/","grade":"human-pk","grade_label":"Human PK","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/limits_text","https://oxytocinbio.com/decision_aid"]},{"id":"clm-105","text":"A dose-response study using 9, 18 and 36 IU found intranasal oxytocin-induced changes in amygdala regional cerebral blood flow followed a dose-response curve with maximal effects for the lower doses, and linked the physiological changes to oxytocin-receptor gene messenger RNA density across brain regions.","source_url":"https://europepmc.org/article/MED/35122880","grade":"human-pk","grade_label":"Human PK","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies"]},{"id":"clm-106","text":"In a randomized four-way crossover in 16 healthy men comparing 8 IU and 24 IU intranasal oxytocin delivered by a Breath Powered device, 1 IU intravenous and placebo, all treatments produced similar plasma increases yet only the 8 IU dose changed anger ratings of emotionally ambiguous faces, with the effect inversely related to nasal valve dimensions, which the authors read as support for a direct nose-to-brain effect independent of blood absorption.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC5068727/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/limits_text"]},{"id":"clm-107","text":"Using deuterium-labelled oxytocin and a mass spectrometry assay in six rhesus macaques given 80 IU by intranasal and intravenous routes, labelled oxytocin reached cerebrospinal fluid by both routes, peripheral administration did not increase endogenous oxytocin in cerebrospinal fluid, and intranasal administration offered no advantage over intravenous for cerebrospinal fluid concentrations.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC5862033/","grade":"animal-pk","grade_label":"Animal PK","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq","https://oxytocinbio.com/limits_text","https://oxytocinbio.com/decision_aid"]},{"id":"clm-108","text":"In four female rhesus macaques with chronic intrathecal catheters given 0.1, 1 and 5 IU/kg, intravenous oxytocin raised plasma dose-dependently while cerebrospinal fluid changed only at the highest intravenous dose, in a study run explicitly because whether intranasal delivery reaches the central nervous system was under intense debate.","source_url":"https://europepmc.org/article/MED/26826355","grade":"animal-pk","grade_label":"Animal PK","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies"]},{"id":"clm-109","text":"The FDA label states oxytocin has a plasma half-life of about 1 to 6 minutes, decreased in late pregnancy and during lactation, with rapid removal from plasma largely by the kidney and liver.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph"]},{"id":"clm-110","text":"Reviewers have stated that many published oxytocin measurements were made with discredited methodology and that claims that peripheral measurements of oxytocin reflect central release are questionable at best.","source_url":"https://europepmc.org/article/MED/26049207","grade":"systematic-review","grade_label":"Systematic review","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/decision_aid"]},{"id":"clm-111","text":"Oxytocin is a peptide and no FDA-approved oral oxytocin product exists; a search of FDA labeled drug products for oxytocin returns injection products only.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph"]},{"id":"clm-112","text":"The FDA label states that following intravenous administration uterine response occurs almost immediately and subsides within 1 hour, and that following intramuscular injection uterine response occurs within 3 to 5 minutes and persists for 2 to 3 hours.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/comparison"]},{"id":"clm-120","text":"The oxytocin nasal spray used in a randomised trial of milk expression delivered 100 microlitres per dose.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC2672698/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/tool-data","https://oxytocinbio.com/studies"]},{"id":"clm-121","text":"Human trials of intranasal oxytocin conventionally use a spray delivering 4 IU per actuation, so a 24 IU dose is three actuations in each nostril.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC9527468/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/tool-data","https://oxytocinbio.com/faq"]},{"id":"clm-122","text":"At the approved nasal strength of 40 USP units per mL, a 4 IU actuation corresponds to 0.1 mL of solution, consistent with the 100 microlitre per dose spray used in the milk-expression trial.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=012285","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/tool-data"]},{"id":"clm-123","text":"Repeated-dosing intranasal oxytocin trials used daily totals of 32 IU (16 IU twice daily), 48 IU, 40 to 80 IU and 96 IU (24 IU four times daily), and the largest and longest trials used the highest daily doses while reporting the clearest null primary results.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC9607840/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/tool-data","https://oxytocinbio.com/faq","https://oxytocinbio.com/decision_aid"]},{"id":"clm-124","text":"Published guidance for the field lists nasal anatomy and airflow dynamics, vascularisation, mode of spray application and formulation as factors that influence transmucosal nasal drug delivery and bioavailability, and states these variables are generally poorly described and controlled in scientific reports.","source_url":"https://europepmc.org/article/MED/23265311","grade":"systematic-review","grade_label":"Systematic review","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/faq","https://oxytocinbio.com/limits_text","https://oxytocinbio.com/tool-data"]},{"id":"clm-140","text":"A systematic review of 38 randomized controlled trials conducted between 1990 and 2010 in 1529 participants, at doses of 18 to 40 IU, found side effects no different between oxytocin and placebo, that participants could not accurately report which they had received, and no adverse outcomes associated with short term use in controlled research settings.","source_url":"https://europepmc.org/article/MED/21429671","grade":"systematic-review","grade_label":"Systematic review","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq","https://oxytocinbio.com/limits_text","https://oxytocinbio.com/comparison"]},{"id":"clm-141","text":"That review also identified three case reports of adverse reactions involving misuse and longer-term use of intranasal oxytocin, and noted the trial population was 79% male with only 8% having developmental or mental health difficulties.","source_url":"https://europepmc.org/article/MED/21429671","grade":"systematic-review","grade_label":"Systematic review","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/limits_text"]},{"id":"clm-142","text":"A systematic review and meta-analysis of adverse events across five randomized trials of long-term intranasal oxytocin in autism, covering 223 participants, found the most common events were nasal discomfort 14.3%, irritability 9.0%, tiredness 7.2%, diarrhea 4.5% and skin irritation 4.5%, none statistically associated with treatment allocation, with five severe adverse events reported: aggression in one placebo and two oxytocin participants and seizures in one of each.","source_url":"https://europepmc.org/article/MED/29232031","grade":"meta-analysis","grade_label":"Meta-analysis","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq"]},{"id":"clm-143","text":"A systematic review of nine randomized controlled trials of intranasal oxytocin in 331 adults aged 60 and over, at 24 to 72 IU, found adverse effects predominantly mild with no significant association with severe outcomes, and states the review may not fully reflect potential adverse events associated with long-term administration.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11804147/","grade":"systematic-review","grade_label":"Systematic review","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq","https://oxytocinbio.com/limits_text","https://oxytocinbio.com/comparison"]},{"id":"clm-144","text":"A 1985 case report describes a nursing mother who developed severe water intoxication with hyponatremic encephalopathy and convulsions in association with excessive and unmonitored self-administration of an oxytocin nasal spray while receiving a large quantity of intravenous fluid; the authors note she subsequently developed a Guillain-Barre type polyneuritis whose associated inappropriate antidiuretic hormone secretion may have contributed, and state the temporal associations strongly favor the unmonitored nasal spray.","source_url":"https://europepmc.org/article/MED/3923190","grade":"human-case-report","grade_label":"Human case report","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq","https://oxytocinbio.com/comparison"]},{"id":"clm-145","text":"That case report notes the historical context that nursing women returning to full-time work were using oxytocin nasal sprays to facilitate breast emptying and that the preparation had been assumed to be innocuous.","source_url":"https://europepmc.org/article/MED/3923190","grade":"human-case-report","grade_label":"Human case report","used_on":["https://oxytocinbio.com/studies"]},{"id":"clm-146","text":"The FDA label states oxytocin has an intrinsic antidiuretic effect increasing water reabsorption, that water intoxication with convulsions is a serious complication that may occur if large doses of 40 to 50 milliunits per minute are infused for long periods, and that severe water intoxication with convulsions and coma has occurred and maternal death due to oxytocin-induced water intoxication has been reported.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/faq","https://oxytocinbio.com/comparison","https://oxytocinbio.com/copy"]},{"id":"clm-147","text":"The FDA label warns that overstimulation of the uterus by improper administration can be hazardous to mother and fetus, that hypertonic contractions can occur even with proper administration in a hypersensitive uterus, and that maternal deaths due to hypertensive episodes, subarachnoid hemorrhage and rupture of the uterus, and fetal deaths, have been reported in association with parenteral oxytocic drugs used for induction or augmentation of labor.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/faq"]},{"id":"clm-148","text":"The FDA label describes overdosage in terms of uterine hyperactivity, with hypertonic or tetanic contractions leading to tumultuous labor, uterine rupture, cervical and vaginal lacerations, postpartum hemorrhage, uteroplacental hypoperfusion, fetal hypoxia and death.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph"]},{"id":"clm-149","text":"One participant in the Japanese autism trial experienced temporary gynecomastia during oxytocin administration.","source_url":"https://europepmc.org/article/MED/29955161","grade":"human-rct","grade_label":"Human RCT","used_on":["https://oxytocinbio.com/monograph"]},{"id":"clm-150","text":"The Pitocin label lists antepartum contraindications including significant cephalopelvic disproportion, unfavorable fetal positions or presentations such as transverse lies, obstetrical emergencies favoring surgical intervention, fetal distress where delivery is not imminent, failure of adequate uterine activity to achieve satisfactory progress, an already hyperactive or hypertonic uterus, cases where vaginal delivery is contraindicated including invasive cervical carcinoma, active herpes genitalis, total placenta previa, vasa previa and cord presentation or prolapse, and hypersensitivity to the drug.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/comparison"]},{"id":"clm-151","text":"The Pitocin label states that severe hypertension has been reported when oxytocin was given three to four hours following prophylactic administration of a vasoconstrictor in conjunction with caudal block anesthesia, and that cyclopropane anesthesia may modify oxytocin's cardiovascular effects producing unexpected results such as hypotension, with maternal sinus bradycardia and abnormal atrioventricular rhythms also noted.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/faq"]},{"id":"clm-152","text":"The Pitocin label documents the full formulation, including 0.5% chlorobutanol as preservative, acetic acid and ammonium acetate buffers, a targeted pH of 3.5, that the product may contain up to 16% of total impurities, and that the hormone is prepared synthetically to avoid possible contamination with vasopressin and other small polypeptides with biologic activity, and directs storage between 20 and 25 degrees Celsius.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/comparison"]},{"id":"clm-153","text":"No published stability dataset or public standard specifies what a compounded nasal oxytocin actuation delivers, and a product that does not state its concentration in IU per mL and its volume per actuation cannot have its per-dose amount calculated.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=012285","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/comparison","https://oxytocinbio.com/tool-data"]},{"id":"clm-160","text":"A Cochrane review of 24 trials, with 23 trials involving 10,018 women contributing data, found prophylactic oxytocin compared with no uterotonics or placebo may reduce blood loss of 500 mL or more after delivery (average risk ratio 0.51, 95% CI 0.37 to 0.72) and blood loss of 1000 mL or more (risk ratio 0.59, 95% CI 0.42 to 0.83).","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC6487388/","grade":"systematic-review","grade_label":"Systematic review","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq","https://oxytocinbio.com/limits_text","https://oxytocinbio.com/decision_aid","https://oxytocinbio.com/comparison"]},{"id":"clm-161","text":"That review found prophylactic oxytocin probably reduces the need for additional uterotonics (average risk ratio 0.54, 95% CI 0.36 to 0.80, moderate-quality evidence), and graded the overall evidence from very low to moderate quality because many trials were assessed at high risk of bias.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC6487388/","grade":"systematic-review","grade_label":"Systematic review","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/faq"]},{"id":"clm-162","text":"A Cochrane network meta-analysis of 122 trials in 121,931 women across 48 countries found all uterotonic agents except injectable prostaglandins, for which data were limited, effective for preventing postpartum haemorrhage of 500 mL or more compared with placebo or no treatment, and ranked ergometrine plus oxytocin and misoprostol plus oxytocin as the two highest agents.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12002006/","grade":"meta-analysis","grade_label":"Meta-analysis","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/studies","https://oxytocinbio.com/limits_text","https://oxytocinbio.com/decision_aid"]},{"id":"clm-163","text":"The current World Health Organization recommendation for preventing postpartum haemorrhage is 10 international units of intramuscular or intravenous oxytocin.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12002006/","grade":"meta-analysis","grade_label":"Meta-analysis","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/faq"]},{"id":"clm-180","text":"Bremelanotide is a melanocortin receptor agonist approved as Vyleesi under NDA 210557, administered subcutaneously by autoinjector.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/comparison"]},{"id":"clm-181","text":"The Vyleesi label indicates it for acquired, generalized hypoactive sexual desire disorder in premenopausal women, and states it is not indicated for hypoactive sexual desire disorder in postmenopausal women or in men, and not indicated to enhance sexual performance.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com/comparison"]},{"id":"clm-182","text":"The Vyleesi recommended dosage is 1.75 mg subcutaneously in the abdomen or thigh at least 45 minutes before anticipated sexual activity, with no more than one dose in 24 hours and no more than 8 doses per month recommended.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/comparison"]},{"id":"clm-183","text":"This site does not restate bremelanotide's registrational trial results secondhand and links to its sister reference site for that detail.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf","grade":"internal-measurement","grade_label":"Internal measurement","used_on":["https://oxytocinbio.com/comparison"]},{"id":"clm-184","text":"The Vyleesi label contraindicates its use in patients who have uncontrolled hypertension or known cardiovascular disease.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://oxytocinbio.com/comparison"]},{"id":"clm-170","text":"This site's study-results table contains 43 rows, of which 41 are human evidence and 2 are nonhuman primate pharmacokinetic studies.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC9701092/","grade":"internal-measurement","grade_label":"Internal measurement","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com","https://oxytocinbio.com/copy"]},{"id":"clm-171","text":"This site cites 65 sources, of which 55 are peer-reviewed journal articles and 10 are government or trial-registry records, giving 100.0% peer-reviewed, governmental or registry material.","source_url":"https://pubchem.ncbi.nlm.nih.gov/compound/439302","grade":"internal-measurement","grade_label":"Internal measurement","used_on":["https://oxytocinbio.com/monograph","https://oxytocinbio.com","https://oxytocinbio.com/copy"]},{"id":"clm-172","text":"Of the 21 randomized human trials in this site's study table that prespecified an efficacy primary endpoint, 12 reported no significant benefit over placebo on that endpoint.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC9701092/","grade":"internal-measurement","grade_label":"Internal measurement","used_on":["https://oxytocinbio.com","https://oxytocinbio.com/copy"]}]}