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Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants
Plain-language guide to PMID 28189361 (2017): double-blind randomized controlled trial study of PT-141 (Bremelanotide) and Alpha-MSH.
Key Facts
- PMID
- 28189361
- Journal
- Clinical therapeutics
- Year
- 2017
- Study type
- Randomized Controlled Trial
- Authors
- Clayton AH et al. (4 authors)
- DOI
- 10.1016/j.clinthera.2017.01.018
What This Study Did, in Plain Language
What Was Tested
This randomized controlled trial paper looks at PT-141 (Bremelanotide) and Alpha-MSH.
Who Took Part
PubMed indexes the participants as adults and middle-aged adults, both men and women.
Individuals meeting the inclusion/exclusion criteria received BMT or placebo with or without ethanol at the research facility for 7 consecutive days.
Vital signs, self-rated sedation scores, nursing and medical observations, and spontaneous reporting by participants provided the basis for evaluation of adverse events.
How the Study Was Run
The design is described as randomized, double-blind, placebo-controlled and crossover.
The participants 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.
Some participants received a placebo instead of PT-141 (Bremelanotide), giving a reference point.
Each person switched between PT-141 (Bremelanotide) and the comparison at some point, usually with a gap in between.
This was a randomized, placebo-controlled, double-blind, 3-period, 3-way crossover study.
A physical examination and a resting 12-lead electrocardiogram were performed at baseline and on study day 7.
Blood and urine samples were obtained for clinical safety profile laboratory tests.
What Was Measured
The subject headings attached to it are Ethanol, Peptides, Cyclic and alpha-MSH.
Author keywords: bremelanotide, female sexual dysfunction, hypoactive sexual desire disorder and melanocortin receptor agonist.
What This Means in Plain Language
The paper is a randomized, double-blind and placebo-controlled study of PT-141 (Bremelanotide) and Alpha-MSH.
Results are reported in around 12 sentences of the abstract; we leave them to the paper itself rather than summarise them.
The publication is from 2017 (Clinical therapeutics), 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.