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Study · Randomized controlled trial · n = 1,247 · 2022

14 results

Safety Profile of Bremelanotide Across the Clinical Development Program.

Clayton AH, Kingsberg SA, Portman D, Sadiq A, Krop J, Jordan R, Lucas J, Simon JA

Journal of women's health (2002)1 Feb 2022Cited by 6 (Europe PMC)

PMID35147466 (opens in a new tab)DOI10.1089/jwh.2021.0191 (opens in a new tab)PepBankPUB-35147466
Publisher pagePubMedAsk about this study
Jump to 14 results

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study14

14 results from studies that gave the peptide. 14 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In the integrated double-blind phase 3 studies, nausea was more frequent with bremelanotide than with placebo.

    In plain wordsIn phase 3 trials, nausea was more common with bremelanotide than with placebo.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    IncreaseNausea incidence (integrated phase 3, double-blind)
    Study

    n = 1,247

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    Incidence
    40%
    bremelanotide
    Incidence
    1.3%
    placebo

    Source sentences

    Summary
    The most common adverse events (AEs) were nausea (40.0% vs. 1.3%), flushing (20.3% vs. 1.3%), headache (11.3% vs. 1.9%), and injection site reactions (5.4 vs. 0.5), bremelanotide versus placebo groups, respectively, in the integrated double-blind portion of the phase 3 studies (N = 1247).
    1 context sentence
    Summary · context
    The clinical development program comprised 3500 subjects in 43 completed studies.
  2. 02HumanRandomized controlled trialSafety outcome

    In the integrated double-blind phase 3 studies, flushing was more frequent with bremelanotide than with placebo.

    In plain wordsIn phase 3 trials, flushing was more common with bremelanotide than with placebo.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    IncreaseFlushing incidence (integrated phase 3, double-blind)
    Study

    n = 1,247

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Measurements

    Incidence
    20.3%
    bremelanotide
    Incidence
    1.3%
    placebo

    Source sentences

    Summary
    The most common adverse events (AEs) were nausea (40.0% vs. 1.3%), flushing (20.3% vs. 1.3%), headache (11.3% vs. 1.9%), and injection site reactions (5.4 vs. 0.5), bremelanotide versus placebo groups, respectively, in the integrated double-blind portion of the phase 3 studies (N = 1247).
    1 context sentence
    Summary · context
    The clinical development program comprised 3500 subjects in 43 completed studies.
  3. 03HumanRandomized controlled trialSafety outcome

    In the integrated double-blind phase 3 studies, headache was more frequent with bremelanotide than with placebo.

    In plain wordsIn phase 3 trials, headache was more common with bremelanotide than with placebo.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    IncreaseHeadache incidence (integrated phase 3, double-blind)
    Study

    n = 1,247

    Comparator
    Placebo
    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    Dose not stated

    Measurements

    Incidence
    11.3%
    bremelanotide
    Incidence
    1.9%
    placebo

    Source sentences

    Summary
    The most common adverse events (AEs) were nausea (40.0% vs. 1.3%), flushing (20.3% vs. 1.3%), headache (11.3% vs. 1.9%), and injection site reactions (5.4 vs. 0.5), bremelanotide versus placebo groups, respectively, in the integrated double-blind portion of the phase 3 studies (N = 1247).
    1 context sentence
    Summary · context
    The clinical development program comprised 3500 subjects in 43 completed studies.
  4. 04HumanRandomized controlled trialSafety outcome

    In the integrated double-blind phase 3 studies, injection site reactions were more frequent with bremelanotide than with placebo.

    In plain wordsIn phase 3 trials, injection site reactions were more common with bremelanotide than with placebo.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    IncreaseInjection site reactions (integrated phase 3, double-blind)
    Study

    n = 1,247

    Comparator
    Placebo
    Outcome group
    Adverse events · Skin and wound
    Studied dose
    Dose not stated

    Measurements

    Incidence
    5.4 not stated
    bremelanotide
    Incidence
    0.5 not stated
    placebo

    Source sentences

    Summary
    The most common adverse events (AEs) were nausea (40.0% vs. 1.3%), flushing (20.3% vs. 1.3%), headache (11.3% vs. 1.9%), and injection site reactions (5.4 vs. 0.5), bremelanotide versus placebo groups, respectively, in the integrated double-blind portion of the phase 3 studies (N = 1247).
    1 context sentence
    Summary · context
    The clinical development program comprised 3500 subjects in 43 completed studies.
  5. 05HumanRandomized controlled trialSafety outcome

    In the bremelanotide clinical development program, nausea was the most common reason for discontinuation.

    In plain wordsIn bremelanotide trials, nausea was the most common reason people stopped taking it.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Not applicableReason for discontinuation
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Nausea was the most common reason for bremelanotide discontinuation.
    1 context sentence
    Summary · context
    The clinical development program comprised 3500 subjects in 43 completed studies.
  6. 06HumanRandomized controlled trialSafety outcome

    No deaths occurred in the bremelanotide clinical development program.

    In plain wordsNo deaths were reported in the bremelanotide trials.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    No significant changeDeaths
    Study

    n: not reported in source

    Outcome group
    Mortality · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    There were no deaths
    1 context sentence
    Summary · context
    The clinical development program comprised 3500 subjects in 43 completed studies.
  7. 07HumanRandomized controlled trialSafety outcome

    In the bremelanotide clinical development program, a few subjects experienced serious adverse events.

    In plain wordsIn bremelanotide trials, a few people had serious side effects.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Not applicableSerious adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    a few subjects experienced serious AEs.
    1 context sentence
    Summary · context
    The clinical development program comprised 3500 subjects in 43 completed studies.
  8. 08HumanRandomized controlled trialSafety outcome

    Focal hyperpigmentation was rare when bremelanotide was dosed in accordance with label recommendations.

    In plain wordsPatchy skin darkening was rare when bremelanotide was used as the label says.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Not applicableFocal hyperpigmentation with label dosing
    Study

    n: not reported in source

    Outcome group
    Pigmentation · Skin and wound
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Focal hyperpigmentation was rare when bremelanotide was dosed in accordance with label recommendations
    1 context sentence
    Summary · context
    The clinical development program comprised 3500 subjects in 43 completed studies.
  9. 09HumanRandomized controlled trialSafety outcome

    Focal hyperpigmentation occurred in more than one-third of subjects after up to 16 consecutive daily bremelanotide doses.

    In plain wordsPatchy skin darkening occurred in more than one-third of people after up to 16 days of daily bremelanotide.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    IncreaseFocal hyperpigmentation after up to 16 consecutive daily doses
    Study

    n: not reported in source

    Outcome group
    Pigmentation · Skin and wound
    Studied dose
    Dose not stated · up to 16 consecutive daysAs given in this study (human).

    Source sentences

    Summary
    it occurred in more than one-third of subjects following up to 16 consecutive daily dosings.
    1 context sentence
    Summary · context
    The clinical development program comprised 3500 subjects in 43 completed studies.
  10. 10HumanRandomized controlled trialSafety outcome

    Bremelanotide produced small, transient but statistically significant blood pressure increases on ambulatory monitoring.

    In plain wordsBremelanotide caused small, short-lived rises in blood pressure.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    IncreaseAmbulatory blood pressure
    Study

    n: not reported in source

    Outcome group
    Blood pressure · Cardiovascular
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Small and transient but statistically significant blood pressure increases were observed during ambulatory blood pressure monitoring.
    1 context sentence
    Summary · context
    The clinical development program comprised 3500 subjects in 43 completed studies.
  11. 11HumanRandomized controlled trialPharmacokinetics

    Bremelanotide lowered plasma concentrations of indomethacin in drug-drug interaction studies.

    In plain wordsBremelanotide lowered blood levels of the drug indomethacin.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    DecreaseIndomethacin plasma concentration (drug interaction)
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated

    Source sentences

    Summary
    except for interactions that lowered plasma concentrations of indomethacin and naltrexone.
    1 context sentence
    Summary · context
    The clinical development program comprised 3500 subjects in 43 completed studies.
  12. 12HumanRandomized controlled trialPharmacokinetics

    Bremelanotide lowered plasma concentrations of naltrexone in drug-drug interaction studies.

    In plain wordsBremelanotide lowered blood levels of the drug naltrexone.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    DecreaseNaltrexone plasma concentration (drug interaction)
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated

    Source sentences

    Summary
    except for interactions that lowered plasma concentrations of indomethacin and naltrexone.
    1 context sentence
    Summary · context
    The clinical development program comprised 3500 subjects in 43 completed studies.
  13. 13HumanRandomized controlled trialPharmacokinetics

    Most drug-drug interactions with bremelanotide were not clinically significant.

    In plain wordsMost interactions between bremelanotide and other drugs were not clinically significant.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    No significant changeOther drug-drug interactions
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Most drug-drug interactions were not clinically significant
    1 context sentence
    Summary · context
    The clinical development program comprised 3500 subjects in 43 completed studies.
  14. 14HumanRandomized controlled trialOther

    In the double-blind portion of the integrated phase 3 studies, fewer subjects on bremelanotide than on placebo proceeded to the open-label phase.

    In plain wordsIn phase 3 trials, fewer people on bremelanotide than on placebo went on to the open-label phase.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    DecreaseProgression to open-label phase
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Treatment adherence and retention · Whole body
    Studied dose
    Dose not stated

    Measurements

    Proceeded to open-label
    70%
    bremelanotide
    Proceeded to open-label
    87%
    placebo

    Source sentences

    Summary
    In the double-blind portion of the integrated phase 3 studies, 70% of the bremelanotide group proceeded to the open-label phase of the studies versus 87% of those on placebo.
    1 context sentence
    Summary · context
    The clinical development program comprised 3500 subjects in 43 completed studies.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 2 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT02338960

2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

Palatin Technologies, Incn = 714Jan 2015 to 29 Jun 2017

Hypoactive Sexual Desire Disorder

Trial pageClinicalTrials.govUpdated 28 Jan 2021
CompletedPhase 3Results postedNCT02333071

1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

Palatin Technologies, Incn = 723Dec 2014 to 30 Jun 2017

Hypoactive Sexual Desire Disorder

Trial pageClinicalTrials.govUpdated 9 Apr 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    9 Oct 2026, 18:17 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:04 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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