Description
PT-141, also known as Bremelanotide, is a synthetic hormone that is derived from alpha-melanocyte-stimulating hormone. It has been heavily modified to act as an agonist for the melanocortin-4 and melanocortin-1 receptors. PT-141 has been tested in clinical trials as a treatment for both male/female hypoactive sexual desire disorder and acute hemorrhage. Research studies suggest that PT-141 promotes sexual arousal and stimulates the immune system.
Specifications
- Chemical Formula: C50H68N14O10
- Molecular Mass: 1025.182g/mol
- Synonyms: PT-141; bremelanotide acetate
- CAS Number: 189691-06-3
- PubChem: 9941379
- Total Amount of the Active Ingredient: 10 mg (1 vial)
- Shelf Life: 36 months
Research Studies
Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder
Abstract
Bremelanotide significantly improves sexual desire and related distress in premenopausal women with hypoactive sexual distress disorder and has a favorable safety profile.
OBJECTIVE:
To evaluate the safety and efficacy of bremelanotide for the treatment of premenopausal women with hypoactive sexual desire disorder.
METHODS:
Two identical phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trials (RECONNECT) evaluated the safety and efficacy of bremelanotide 1.75 mg administered subcutaneously as needed in premenopausal women with hypoactive sexual desire disorder. Patients were randomized 1:1 to 24 weeks of treatment with bremelanotide or placebo. Sample size was estimated based on simulations from key endpoints in patients with hypoactive sexual desire disorder from a prior trial. Coprimary efficacy endpoints were change from baseline to end-of-study in the Female Sexual Function Index–desire domain score and Female Sexual Distress Scale–Desire/Arousal/Orgasm item 13.
RESULTS:
Study 301 began on January 7, 2015, and concluded on July 26, 2016. Study 302 began on January 28, 2015, and concluded on August 4, 2016. Of the 1,267 women randomized, 1,247 and 1,202 were in the safety and efficacy (modified intent-to-treat) populations, respectively. Most participants were white (85.6%), from U.S. sites (96.6%), and had a mean age of 39 years. From baseline to end-of-study, women taking bremelanotide had statistically significant increases in sexual desire (study 301: 0.30, P<.001; study 302: 0.42, P<.001; integrated studies 0.35, P<.001) and statistically significant reductions in distress related to low sexual desire (study 301: −0.37, P<.001; study 302: −0.29, P=.005; integrated studies −0.33, P<.001) compared with placebo. Patients taking bremelanotide experienced more nausea, flushing, and headache (10% or more in both studies) compared with placebo.
CONCLUSIONS:
Both studies demonstrated that bremelanotide significantly improved sexual desire and related distress in premenopausal women with hypoactive sexual desire disorder. The safety profile was favorable. Most treatment-emergent adverse events were related to tolerability and the majority were mild or moderate in intensity.
Abstract
Introduction
Melanocortins affect multiple physiological responses, including sexual behaviors. Bremelanotide is a synthetic peptide melanocortin analog of α‐melanocyte‐stimulating hormone that is an agonist at melanocortin receptors MC3R and MC4R.
Aim
To evaluate a single intranasal dose of bremelanotide for potential effects on physiological and subjective measurements of sexual arousal and desire in premenopausal women with sexual arousal disorder.
Main Outcome Measures
Change in vaginal pulse amplitude during neutral and erotic videos after treatment with bremelanotide or placebo and subjects’ perceptions of physiological and sexual response within 24 hours of treatment with bremelanotide or placebo.
Methods
Eighteen premenopausal women with a primary diagnosis of female sexual arousal disorder were randomly assigned to receive a single intranasal dose of 20 mg bremelanotide or matching placebo in a double‐blind manner during the first in‐clinic treatment session, and the alternate medication during the second in‐clinic treatment session. During each session, subjects viewed a 20‐minute neutral video followed by a 20‐minute sexually explicit video. Vaginal photoplethysmography was used to monitor vaginal vasocongestion and questionnaires were used to evaluate perceptions of sexual response within the following 24‐hour period.
Results
More women reported moderate or high sexual desire following bremelanotide treatment vs. placebo (P = 0.0114), and a trend toward more positive responses regarding feelings of genital arousal occurred after bremelanotide compared with placebo (P = 0.0833). Among women who attempted sexual intercourse within 24 hours after treatment, significantly more were satisfied with their level of sexual arousal following bremelanotide, compared with placebo (P = 0.0256). Vaginal vasocongestion did not change significantly while viewing erotic videos following bremelanotide administration compared with placebo.
Conclusion
This preliminary evaluation suggests the potential for bremelanotide to positively affect desire and arousal in women with female sexual arousal disorder and indicates that bremelanotide is a promising candidate for further evaluation in an at‐home study. Diamond LE, Earle DC, Heiman JR, Rosen RC, Perelman MA, and Harning R. An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT‐141), a melanocortin receptor agonist. J Sex Med 2006;3:628–638.
PT-141: a melanocortin agonist for the treatment of sexual dysfunction
Abstract
PT-141, a synthetic peptide analogue of alpha-MSH, is an agonist at melanocortin receptors including the MC3R and MC4R, which are expressed primarily in the central nervous system. Administration of PT-141 to rats and nonhuman primates results in penile erections. Systemic administration of PT-141 to rats activates neurons in the hypothalamus as shown by an increase in c-Fos immunoreactivity. Neurons in the same region of the central nervous system take up pseudorabies virus injected into the corpus cavernosum of the rat penis. Administration of PT-141 to normal men and to patients with erectile dysfunction resulted in a rapid dose-dependent increase in erectile activity. The results suggest that PT-141 holds promise as a new treatment for sexual dysfunction.
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The products offered on this website are intended for in-vitro studies only. In-vitro studies (Latin: “in glass”) are performed outside the body. These products are not medicines or drugs and have not been approved by the FDA to prevent, treat, or cure any medical condition, ailment, or disease. Bodily introduction of any kind into humans or animals is strictly forbidden by law.
