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Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide

Plain-language guide to PMID 35230162 (2022): double-blind randomized controlled trial study of PT-141 (Bremelanotide) and Alpha-MSH in 1202 patients.

Key Facts

PMID
35230162
Journal
Journal of women's health (2002)
Year
2022
Study type
Randomized Controlled Trial
Authors
Simon JA et al. (8 authors)
DOI
10.1089/jwh.2021.0225

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: Hypoactive sexual desire disorder (HSDD), the most prevalent female sexual dysfunction, is characterized as persistent diminished desire for sexual activity accompanied by distress.

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.

Who Took Part

According to the abstract, 1202 patients were involved.

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.

The patients were allocated by chance, so the PT-141 (Bremelanotide) group and the comparison group should start out alike.

As a double-blind PT-141 (Bremelanotide) study, the assignments were hidden from both participants and investigators until the end.

Being open-label, the PT-141 (Bremelanotide) study did not mask who received what.

The comparison arm used a placebo, so changes seen with PT-141 (Bremelanotide) could be set against what happens without it.

The methods mention a period of 24 weeks.

What Was Measured

Topics PubMed links to this paper include Libido, Peptides, Cyclic, Sexual Dysfunctions, Psychological and alpha-MSH.

The authors tagged it with the keywords bremelanotide, female, 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 1202 patients over 24 weeks.

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.