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Study · Randomized controlled trial · 2016

6 results

Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial.

Clayton AH, Althof SE, Kingsberg S, DeRogatis LR, Kroll R, Goldstein I, Kaminetsky J, Spana C, Lucas J, Jordan R, Portman DJ

Women's health (London, England)16 May 2016Cited by 58 (Europe PMC)

PMID27181790 (opens in a new tab)PMCIDPMC5384512 (opens in a new tab)DOI10.2217/whe-2016-0018 (opens in a new tab)PepBankPUB-27181790
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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 study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In premenopausal women with female sexual dysfunctions, pooled bremelanotide 1.25 and 1.75 mg increased satisfying sexual events per month more than placebo.

    In plain wordsIn premenopausal women with sexual dysfunction, bremelanotide led to more satisfying sexual events per month than placebo.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    IncreaseChange in satisfying sexual events per month
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Sexual function · Reproductive and sexual health
    Studied dose
    1.25 and 1.75 mg pooled · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    Change in satisfying sexual events
    0.7 events/month
    1.25/1.75 mg pooled
    Change in satisfying sexual events
    0.2 events/month
    placebo

    Source sentences

    Summary
    For 1.25/1.75-mg pooled versus placebo, mean changes from baseline to study end were +0.7 versus +0.2 satisfying sexual events/month (p = 0.0180)
    1 context sentence
    Summary · context
    Patients randomized to receive placebo or BMT 0.75, 1.25 or 1.75 mg self-administered subcutaneously, as desired, over 12 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In premenopausal women with female sexual dysfunctions, pooled bremelanotide 1.25 and 1.75 mg raised the Female Sexual Function Index total score more than placebo.

    In plain wordsIn premenopausal women with sexual dysfunction, bremelanotide improved overall sexual function scores more than placebo.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    IncreaseChange in Female Sexual Function Index total score
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Sexual function · Reproductive and sexual health
    Studied dose
    1.25 and 1.75 mg pooled · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    FSFI total score change
    3.6 points
    1.25/1.75 mg pooled
    FSFI total score change
    1.9 points
    placebo

    Source sentences

    Summary
    +3.6 versus +1.9 female sexual function index total score (p = 0.0017)
    2 context sentences
    Summary · context
    For 1.25/1.75-mg pooled versus placebo
    Summary · context
    Patients randomized to receive placebo or BMT 0.75, 1.25 or 1.75 mg self-administered subcutaneously, as desired, over 12 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In premenopausal women with female sexual dysfunctions, pooled bremelanotide 1.25 and 1.75 mg lowered the Female Sexual Distress Scale-Desire/Arousal/Orgasm total score more than placebo.

    In plain wordsIn premenopausal women with sexual dysfunction, bremelanotide reduced sexual distress scores more than placebo.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    DecreaseChange in FSDS-DAO total score
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Sexual function · Reproductive and sexual health
    Studied dose
    1.25 and 1.75 mg pooled · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    FSDS-DAO total score change
    −11.1 points
    1.25/1.75 mg pooled
    FSDS-DAO total score change
    −6.8 points
    placebo

    Source sentences

    Summary
    -11.1 versus -6.8 female sexual distress scale-desire/arousal/orgasm total score (p = 0.0014)
    2 context sentences
    Summary · context
    For 1.25/1.75-mg pooled versus placebo
    Summary · context
    Patients randomized to receive placebo or BMT 0.75, 1.25 or 1.75 mg self-administered subcutaneously, as desired, over 12 weeks.
  4. 04HumanRandomized controlled trialSafety outcome

    In premenopausal women with female sexual dysfunctions, nausea was listed as an adverse event of bremelanotide; the abstract gives no rate or comparison.

    In plain wordsIn premenopausal women, nausea was reported as a side effect of bremelanotide. The abstract gives no numbers.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Direction not reportedNausea
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    0.75, 1.25 and 1.75 mg · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Adverse events: nausea, flushing, headache.
    1 context sentence
    Summary · context
    Patients randomized to receive placebo or BMT 0.75, 1.25 or 1.75 mg self-administered subcutaneously, as desired, over 12 weeks.
  5. 05HumanRandomized controlled trialSafety outcome

    In premenopausal women with female sexual dysfunctions, flushing was listed as an adverse event of bremelanotide; the abstract gives no rate or comparison.

    In plain wordsIn premenopausal women, flushing was reported as a side effect of bremelanotide. The abstract gives no numbers.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Direction not reportedFlushing
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.75, 1.25 and 1.75 mg · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Adverse events: nausea, flushing, headache.
    1 context sentence
    Summary · context
    Patients randomized to receive placebo or BMT 0.75, 1.25 or 1.75 mg self-administered subcutaneously, as desired, over 12 weeks.
  6. 06HumanRandomized controlled trialSafety outcome

    In premenopausal women with female sexual dysfunctions, headache was listed as an adverse event of bremelanotide; the abstract gives no rate or comparison.

    In plain wordsIn premenopausal women, headache was reported as a side effect of bremelanotide. The abstract gives no numbers.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Direction not reportedHeadache
    Study

    n: not reported in source

    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    0.75, 1.25 and 1.75 mg · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Adverse events: nausea, flushing, headache.
    1 context sentence
    Summary · context
    Patients randomized to receive placebo or BMT 0.75, 1.25 or 1.75 mg self-administered subcutaneously, as desired, over 12 weeks.

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

Registered trials1

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

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT01382719

Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder

Palatin Technologies, Incn = 612Jun 2011 to Sept 2012

Female Sexual Arousal Disorder · Hypoactive Sexual Desire Disorder

Trial pageClinicalTrials.govUpdated 18 Dec 2014

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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