1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
Palatin Technologies, Inc723 participantsDec 2014 to 30 Jun 2017
Hypoactive Sexual Desire Disorder
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated
Comparing 2 peptides · Data version 308560
Swipe sideways to see every peptide.
| Peptide | Synthetic analog Bremelanotide (PT-141) | Natural peptide Oxytocin | |
|---|---|---|---|
| Identity | |||
| Kind | Synthetic analog | Natural peptide | |
| Area | Sexual health and hormones | Sexual health and hormones | |
| Evidence | |||
| Amount of evidence | 128 | 3,492 (plus 1,148 on natural levels, listed separately) | |
| Evidence level | Has results from studies in people | Has results from studies in people | |
| Safety | |||
| Safety results | 42 (40 in people) | 157 (152 in people) | |
| Status | |||
| Approval | |||
| Sport (WADA) | |||
| Registered trials | 10 · 1 active | 690 · 65 active238 more mention it but do not test it | |
Shared outcomes
From the regulatory data of each peptide.
The FDA label for Vyleesi says: “Premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) with low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, relationship problems, or a medication or drug” No central EU authorisation (EMA).
Outcome groups with study results for at least two of these peptides. Counts include only results from studies that gave the peptide. Bar length is the number of results, on one scale. The bars show how much was studied, not how large an effect was. A peptide with more studies can look stronger here without being stronger. For results, see the randomized results above.
| Outcome group | Bremelanotide (PT-141) | Oxytocin |
|---|---|---|
| Adverse eventsWhole body | 2929 | 1261233 |
| Receptor activity and mechanismNervous system and cognition |
PepBank is a research reference. Talk to a doctor before you use any peptide.
The FDA label for Pitocin says: “Antepartum: medically indicated induction of labor, stimulation or reinforcement of labor, adjunctive therapy in incomplete or inevitable abortion” No central EU authorisation (EMA).
10532 |
28960801472 |
| Sexual functionReproductive and sexual health | 5238122 | 7647245 |
|---|
| PharmacokineticsPharmacology | 1082 | 9168203 |
|---|
| Appetite and food intakeMetabolic and weight | 22 | 946727 |
|---|
| Sex hormones and fertilityEndocrine and hormones | 44 | 150328632 |
|---|
| Heart functionCardiovascular | 11 | 76353110 |
|---|
| Blood pressureCardiovascular | 55 | 5219249 |
|---|
| Body weightMetabolic and weight | 22 | 23176 |
|---|
| Exercise and physical functionNervous system and cognition | 11 | 1717 |
|---|
| Treatment adherence and retentionWhole body | 11 | 66 |
|---|
| Tumor growthCancer | 44 | 6411 |
|---|
Each analog against its native parent, residue by residue. Substitutions, non-standard residues and modifications are marked. Calculated from the two sequences.
Bremelanotide (PT-141) differs from Alpha-melanocyte-stimulating hormone (alpha-MSH) at 4 positions.
What is different
For each outcome that two or more peptides have results for: the best result of a single randomized trial, on the same measure (the same kind of number, the same unit). When a trial has several dose arms, the cell shows the highest dose arm. The trials differ in people, length and dose, so a gap between two cells is not proof that one peptide works better.
| Outcome | Bremelanotide (PT-141) | Oxytocin |
|---|---|---|
| Appetite and food intakeMetabolic and weightCompared as: difference from placebo, in kcal | 398 to 469 kcal Mean difference in caloric intake 4-day treatment periodsn not reported2022 | −152 kcal Difference in caloric intake Dose studied: 24 IU four times daily8 weeksn = 612024 |
| Body weightMetabolic and weightCompared as: value in the arm that got the peptide, in kg | −1.7 kg Mean body weight reduction · Shown as a change. The study reports a mean body weight reduction of this size. Placebo: −0.9 kg 4-day treatment periodsn not reported2022 |
398 to 469 kcal
Mean difference in caloric intake
4-day treatment periodsn not reported2022
−152 kcal
Difference in caloric intake
Dose studied: 24 IU four times daily8 weeksn = 612024
The other peptides have no randomized result on the same measure, so these results cannot be set side by side.
| Outcome | Bremelanotide (PT-141) | Oxytocin |
|---|---|---|
| PharmacokineticsPharmacologyCompared as: value in the arm that got the peptide, in effect size | No comparable result 8 randomized-trial results measure it in another way or another unit. | −1.12 effect size Effect size Dose studied: 48 IU/day6 weeksn = 1032020 |
0.2 kg
Body weight change
Placebo: 0.26 kg
Dose studied: 24 IU four times daily8 weeksn = 612024
−1.7 kg
Mean body weight reduction · Shown as a change. The study reports a mean body weight reduction of this size.
Placebo: −0.9 kg
4-day treatment periodsn not reported2022
0.2 kg
Body weight change
Placebo: 0.26 kg
Dose studied: 24 IU four times daily8 weeksn = 612024
| Sex hormones and fertilityEndocrine and hormonesCompared as: value in the arm that got the peptide, in % | No comparable result 4 randomized-trial results measure it in another way or another unit. | 14.4% Mean percent change testosterone Dose studied: 24 IUn = 452020 |
|---|
| Sexual functionReproductive and sexual healthCompared as: value in the arm that got the peptide, in % | No comparable result 26 randomized-trial results measure it in another way or another unit. | 26% FSFI score change Placebo: 31% Dose studied: 32 IU8 weeksn = 302015 |
|---|
| Receptor activity and mechanismNervous system and cognitionCompared as: value in the arm that got the peptide, in proteins | No comparable result 5 randomized-trial results measure it in another way or another unit. | 198 proteins Differentially expressed proteins Dose studied: 24 IUsingle dosen = 192026 |
|---|
| Treatment adherence and retentionWhole bodyCompared as: value in the arm that got the peptide, in % | 70% Proceeded to open-label Placebo: 87% n not reported2022 | No comparable result 6 randomized-trial results measure it in another way or another unit. |
|---|
| Exercise and physical functionNervous system and cognitionCompared as: difference from placebo, in kg | No randomized trial result 1 result from other study designs. | 2.25 kg Whole body lean mass difference Dose studied: 24 IU 4 times per day8 weeksn = 212021 |
|---|
| Adverse eventsWhole bodyCompared as: share of people in the arm that got the peptide, in % | ≥ 10% Nausea incidence Dose studied: 1.75 mg24 weeksn = 1,2472019 | No comparable result 66 randomized-trial results measure it in another way or another unit. |
|---|
| Blood pressureCardiovascularCompared as: value in the arm that got the peptide, in μg (phenylephrine equivalents) | No comparable result 5 randomized-trial results measure it in another way or another unit. | 1303 μg (phenylephrine equivalents) Cumulative vasopressor requirement Placebo: 1156 μg (phenylephrine equivalents) Dose studied: 100 μgn = 902023 |
|---|
No comparable result
8 randomized-trial results measure it in another way or another unit.
−1.12 effect size
Effect size
Dose studied: 48 IU/day6 weeksn = 1032020
No comparable result
4 randomized-trial results measure it in another way or another unit.
14.4%
Mean percent change testosterone
Dose studied: 24 IUn = 452020
No comparable result
26 randomized-trial results measure it in another way or another unit.
26%
FSFI score change
Placebo: 31%
Dose studied: 32 IU8 weeksn = 302015
No comparable result
5 randomized-trial results measure it in another way or another unit.
198 proteins
Differentially expressed proteins
Dose studied: 24 IUsingle dosen = 192026
70%
Proceeded to open-label
Placebo: 87%
n not reported2022
No comparable result
6 randomized-trial results measure it in another way or another unit.
No randomized trial result
1 result from other study designs.
2.25 kg
Whole body lean mass difference
Dose studied: 24 IU 4 times per day8 weeksn = 212021
≥ 10%
Nausea incidence
Dose studied: 1.75 mg24 weeksn = 1,2472019
No comparable result
66 randomized-trial results measure it in another way or another unit.
No comparable result
5 randomized-trial results measure it in another way or another unit.
1303 μg (phenylephrine equivalents)
Cumulative vasopressor requirement
Placebo: 1156 μg (phenylephrine equivalents)
Dose studied: 100 μgn = 902023
Registered trials, ranked by phase (late phases first), then posted results and enrollment. Status is the registry status. Study results come from published studies. Results posted at ClinicalTrials.gov are shown on each trial page.
Top 3 of 10 trials, ranked by phase, then posted results and enrollment: 3 completed · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)
Palatin Technologies, Inc723 participantsDec 2014 to 30 Jun 2017
Hypoactive Sexual Desire Disorder
Palatin Technologies, Inc714 participantsJan 2015 to 29 Jun 2017
Hypoactive Sexual Desire Disorder
Imperial College Healthcare NHS Trust40 participants7 Oct 2019 to 6 Oct 2020
Hypoactive Sexual Desire Disorder
Top 3 of 690 trials, ranked by phase, then posted results and enrollment: 3 completed · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)
University of Alabama at Birmingham1,798 participantsNov 2008 to Jun 2010
Uterine Atony · Postpartum Hemorrhage
Northwestern University1,003 participants28 Sept 2015 to 28 Sept 2020
Dystocia
University of Zimbabwe506 participants8 Apr 2018 to 30 Jun 2019
Post Partum Hemorrhage
238 more mention it but do not test it. They only measure it or name it in their text.