Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide.
Simon. James A JA; Kingsberg. Sheryl A SA; Portman. David D; Jordan. Robert R; Lucas. Johna J; Sadiq. Amama A; Krop. Julie J; Clayton. Anita H AH
Key Findings
- Significant increase in sexual desire and decrease in distress across all age, weight, and BMI groups
- Efficacy is consistent across all baseline bioavailable testosterone quartiles
- Works whether or not the user is taking hormonal contraceptives, with a slight numeric edge when they are
Practical Outcomes
- For self‑experimenters, a 1.75 mg subcutaneous dose taken as needed before sexual activity can be expected to boost desire without needing dose adjustments for body size or hormone levels. It appears safe for use with or without hormonal contraceptives, but users should watch for typical side‑effects and follow medical guidance.
Summary
Bremelanotide (pt‑141) taken as a 1.75 mg injection before sex reliably lifts desire and cuts distress in pre‑menopausal women with low sexual drive, and it works the same way no matter the woman's age, weight, BMI, testosterone level, or whether she’s on hormonal birth control.
Abstract
<b><i>Background:</i></b> Hypoactive sexual desire disorder (HSDD), the most prevalent female sexual dysfunction, is characterized as persistent diminished desire for sexual activity accompanied by distress. The efficacy and safety of bremelanotide, a melanocortin receptor agonist approved by the U.S. Food and Drug Administration for treatment of acquired generalized HSDD in premenopausal women, were established in the phase 3 RECONNECT studies, two identically designed double-blind randomized placebo-controlled studies with an optional 52-week open-label extension. This report investigates efficacy of bremelanotide versus placebo according to prespecified subgroups (age, weight, body mass index [BMI], and bioavailable testosterone) in the RECONNECT studies. <b><i>Materials and Methods:</i></b> Patients self-administered bremelanotide 1.75 mg or placebo subcutaneously using an autoinjector, as needed, before sexual activity for 24 weeks. Efficacy was assessed using change from baseline to end-of-study for Female Sexual Function Index desire domain and Female Sexual Distress Scale-Desire/Arousal/Orgasm Item 13 for bremelanotide versus placebo. <b><i>Results:</i></b> Among 1202 patients included in the integrated and subgroup analyses, bremelanotide achieved statistically significant improvements in measures of increased desire and decreased distress associated with low desire across all age, weight, and BMI subgroups, and all baseline bioavailable testosterone quartiles, with few exceptions. Bremelanotide was further associated with statistically significant increases in reported sexual desire (<i>p</i> < 0.05) in patients not taking hormonal contraceptives, and with a numerical advantage in those taking hormonal contraceptives. Patients treated with bremelanotide experienced decreased distress compared with those in the placebo group at levels of statistical significance (<i>p</i> < 0.05) regardless of hormonal contraceptive use. Statistically significant improvements were observed in the presence or absence of decreased arousal, and regardless of HSDD duration. <b><i>Conclusions:</i></b> Bremelanotide was associated with statistically significant improvements in sexual desire and reduced distress across several prespecified subgroups, with few exceptions.
Study Information
pubmed
2022
2022-02-25T00:00:00.000Z
10.1089/jwh.2021.0225
6
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