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Study · Randomized controlled trial · n = 24 · 2017

7 results

Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants.

Clayton AH, Lucas J, DeRogatis LR, Jordan R

Clinical therapeutics9 Feb 2017Cited by 10 (Europe PMC)

PMID28189361 (opens in a new tab)DOI10.1016/j.clinthera.2017.01.018 (opens in a new tab)PepBankPUB-28189361
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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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In healthy adults, single 20 mg intranasal bremelanotide doses, with or without ethanol, were safe and generally well tolerated.

    In plain wordsIn healthy adults, bremelanotide nasal doses, with or without alcohol, were generally well tolerated in this small study.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    No significant changeOverall safety and tolerability with or without ethanol
    Study

    n = 24

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    20 mg · intranasal · 7 daysAs given in this study (human).

    Source sentences

    Summary
    Single doses of 20 mg intranasal BMT, administered with or without 0.6 g/kg ethanol, were found to be safe and generally well tolerated
    2 context sentences
    Summary · context
    This was a randomized, placebo-controlled, double-blind, 3-period, 3-way crossover study.
    Summary · context
    Participants were randomized to receive 1 of 6 treatment paths; each participant received single intranasal doses of BMT (20 mg) or placebo on days 1, 4, and 7, with or without oral ethanol (0.6 g/kg) while in a fasted state.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy adults, no clinically significant pharmacokinetic interaction was found between ethanol and intranasal bremelanotide, overall or by sex.

    In plain wordsIn healthy adults, alcohol did not clinically change how bremelanotide moved through the body.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    No significant changePharmacokinetic interaction between ethanol and bremelanotide
    Study

    n = 24

    Comparator
    Bremelanotide with versus without ethanol
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    20 mg · intranasal · 7 daysAs given in this study (human).

    Source sentences

    Summary
    No clinically significant pharmacokinetic interactions were found between ethanol and BMT either overall or by sex.
    2 context sentences
    Summary · context
    This was a randomized, placebo-controlled, double-blind, 3-period, 3-way crossover study.
    Summary · context
    Participants were randomized to receive 1 of 6 treatment paths; each participant received single intranasal doses of BMT (20 mg) or placebo on days 1, 4, and 7, with or without oral ethanol (0.6 g/kg) while in a fasted state.
  3. 03HumanRandomized controlled trialSafety outcome

    In healthy adults, intranasal bremelanotide caused no significant drug-related hypotensive or orthostatic hypotensive effects.

    In plain wordsIn healthy adults, bremelanotide nasal doses did not cause significant drops in blood pressure.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    No significant changeHypotensive and orthostatic hypotensive effects
    Study

    n = 24

    Comparator
    Placebo
    Outcome group
    Blood pressure · Cardiovascular
    Studied dose
    20 mg · intranasal · 7 daysAs given in this study (human).

    Source sentences

    Summary
    No significant drug-related hypotensive or orthostatic hypotensive effects were noted.
    2 context sentences
    Summary · context
    This was a randomized, placebo-controlled, double-blind, 3-period, 3-way crossover study.
    Summary · context
    Participants were randomized to receive 1 of 6 treatment paths; each participant received single intranasal doses of BMT (20 mg) or placebo on days 1, 4, and 7, with or without oral ethanol (0.6 g/kg) while in a fasted state.
  4. 04HumanRandomized controlled trialSafety outcome

    In healthy adults, bremelanotide did not increase the frequency of treatment-emergent adverse events.

    In plain wordsIn healthy adults, bremelanotide did not cause more side effects than placebo in this small study.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    No significant changeFrequency of treatment-emergent adverse events
    Study

    n = 24

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    20 mg · intranasal · 7 daysAs given in this study (human).

    Source sentences

    Summary
    Treatment with BMT did not result in an increased frequency of treatment-emergent adverse events
    2 context sentences
    Summary · context
    This was a randomized, placebo-controlled, double-blind, 3-period, 3-way crossover study.
    Summary · context
    Participants were randomized to receive 1 of 6 treatment paths; each participant received single intranasal doses of BMT (20 mg) or placebo on days 1, 4, and 7, with or without oral ethanol (0.6 g/kg) while in a fasted state.
  5. 05HumanRandomized controlled trialSafety outcome

    In healthy adults, no participants discontinued the study because of adverse events.

    In plain wordsIn healthy adults in this small study, nobody stopped taking part because of side effects.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    No significant changeDiscontinuation due to adverse events
    Study

    n = 24

    Outcome group
    Adverse events · Whole body
    Studied dose
    20 mg · intranasal · 7 daysAs given in this study (human).

    Source sentences

    Summary
    and no participants discontinued the study because of adverse events.
    2 context sentences
    Summary · context
    This was a randomized, placebo-controlled, double-blind, 3-period, 3-way crossover study.
    Summary · context
    Participants were randomized to receive 1 of 6 treatment paths; each participant received single intranasal doses of BMT (20 mg) or placebo on days 1, 4, and 7, with or without oral ethanol (0.6 g/kg) while in a fasted state.
  6. 06HumanRandomized controlled trialSafety outcome

    In healthy adults, physical examination, electrocardiography and laboratory tests showed no clinically significant changes.

    In plain wordsIn healthy adults, check-ups, heart tracings and lab tests showed no important changes.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    No significant changePhysical examination, ECG and laboratory findings
    Study

    n = 24

    Outcome group
    Adverse events · Whole body
    Studied dose
    20 mg · intranasal · 7 daysAs given in this study (human).

    Source sentences

    Summary
    Physical examination, electrocardiography, and laboratory tests disclosed no clinically significant changes.
    2 context sentences
    Summary · context
    This was a randomized, placebo-controlled, double-blind, 3-period, 3-way crossover study.
    Summary · context
    Participants were randomized to receive 1 of 6 treatment paths; each participant received single intranasal doses of BMT (20 mg) or placebo on days 1, 4, and 7, with or without oral ethanol (0.6 g/kg) while in a fasted state.
  7. 07HumanRandomized controlled trialSafety outcome

    In healthy adults, no drug-related serious adverse events were reported with bremelanotide and ethanol.

    In plain wordsIn healthy adults, no serious side effects linked to the drug were reported.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    No significant changeDrug-related serious adverse events
    Study

    n = 24

    Outcome group
    Adverse events · Whole body
    Studied dose
    20 mg · intranasal · 7 daysAs given in this study (human).

    Source sentences

    Summary
    with no reports of drug-related serious adverse events.
    2 context sentences
    Summary · context
    This was a randomized, placebo-controlled, double-blind, 3-period, 3-way crossover study.
    Summary · context
    Participants were randomized to receive 1 of 6 treatment paths; each participant received single intranasal doses of BMT (20 mg) or placebo on days 1, 4, and 7, with or without oral ethanol (0.6 g/kg) while in a fasted state.

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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