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Safety Profile of Bremelanotide Across the Clinical Development Program
Plain-language guide to PMID 35147466 (2022): double-blind randomized controlled trial study of PT-141 (Bremelanotide) and Alpha-MSH in 3500 subjects.
Key Facts
- PMID
- 35147466
- Journal
- Journal of women's health (2002)
- Year
- 2022
- Study type
- Randomized Controlled Trial
- Authors
- Clayton AH et al. (8 authors)
- DOI
- 10.1089/jwh.2021.0191
What This Study Did, in Plain Language
What Was Tested
The paper reports a study of PT-141 (Bremelanotide) and Alpha-MSH, published as a randomized controlled trial.
Background: Bremelanotide, a melanocortin receptor agonist, is Food and Drug Administration (FDA)-approved for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder.
Methods: Review of bremelanotide's safety profile from the clinical development program (phases 1 through 3).
Who Took Part
The abstract describes 3500 subjects taking part.
PubMed tags the participants as women only.
How the Study Was Run
The researchers set it up as a randomized, double-blind, open-label and placebo-controlled study.
Random assignment meant chance, not the researchers, decided who got PT-141 (Bremelanotide) and who got the comparison, which limits bias.
Neither the subjects nor the staff measuring them knew who was on PT-141 (Bremelanotide), so expectations could not easily colour the readings.
Everyone knew when PT-141 (Bremelanotide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
A placebo (an inactive look-alike) gave the PT-141 (Bremelanotide) group a baseline to be compared against.
A time span of 18 months appears in the methods.
What Was Measured
Topics PubMed links to this paper include Blood Pressure Monitoring, Ambulatory, Libido, Peptides, Cyclic and alpha-MSH.
Author keywords: bremelanotide, hypoactive sexual desire disorder and premenopausal.
What This Means in Plain Language
The paper is a randomized, double-blind and open-label study of PT-141 (Bremelanotide) and Alpha-MSH in 3500 subjects over 18 months.
With several hundred people or more, it is a fairly large study for this kind of research.
The publication is from 2022 (Journal of women's health (2002)), a journal based in United States.
More context: the PT-141 (Bremelanotide) compound page and the Alpha-MSH compound page, all human trials.
Our Notes on the Compounds
PT-141 (Bremelanotide): A melanocortin (MC4R) agonist that acts on arousal centers in the brain.
Alpha-MSH: A 13-amino-acid hormone that drives skin pigmentation and calms inflammation; afamelanotide (Melanotan I) is an analog.
Related Pages
Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.