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Study · Randomized controlled trial · n = 1,247 · 2019

6 results

Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials.

Kingsberg SA, Clayton AH, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Simon JA

Obstetrics and gynecology1 Nov 2019Cited by 95 (Europe PMC)

PMID31599840 (opens in a new tab)PMCIDPMC6819021 (opens in a new tab)DOI10.1097/aog.0000000000003500 (opens in a new tab)PepBankPUB-31599840
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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 hypoactive sexual desire disorder, bremelanotide increased Female Sexual Function Index desire scores more than placebo in both studies and in the integrated analysis.

    In plain wordsIn premenopausal women with low sexual desire, bremelanotide raised desire scores more than placebo.

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

    n = 1,202

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Sexual function · Reproductive and sexual health
    Studied dose
    1.75 mg · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    FSFI-desire difference vs placebo
    0.3 points
    study 301
    FSFI-desire difference vs placebo
    0.42 points
    study 302
    FSFI-desire difference vs placebo
    0.35 points
    integrated studies

    Source sentences

    Summary
    women taking bremelanotide had statistically significant increases in sexual desire (study 301: 0.30, P<.001; study 302: 0.42, P<.001; integrated studies 0.35, P<.001)
    2 context sentences
    Summary · context
    Two identical phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trials (RECONNECT) evaluated the safety and efficacy of bremelanotide 1.75 mg administered subcutaneously as needed in premenopausal women with hypoactive sexual desire disorder.
    Summary · context
    Patients were randomized 1:1 to 24 weeks of treatment with bremelanotide or placebo.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In premenopausal women with hypoactive sexual desire disorder, bremelanotide reduced distress related to low sexual desire more than placebo in both studies and in the integrated analysis.

    In plain wordsIn premenopausal women with low sexual desire, bremelanotide reduced distress about low desire more than placebo.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    DecreaseChange in distress related to low sexual desire (FSDS-DAO item 13)
    Study

    n = 1,202

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Sexual function · Reproductive and sexual health
    Studied dose
    1.75 mg · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    Distress score difference vs placebo
    −0.37 points
    study 301
    Distress score difference vs placebo
    −0.29 points
    study 302
    Distress score difference vs placebo
    −0.33 points
    integrated studies

    Source sentences

    Summary
    statistically significant reductions in distress related to low sexual desire (study 301: -0.37, P<.001; study 302: -0.29, P=.005; integrated studies -0.33, P<.001) compared with placebo
    2 context sentences
    Summary · context
    Two identical phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trials (RECONNECT) evaluated the safety and efficacy of bremelanotide 1.75 mg administered subcutaneously as needed in premenopausal women with hypoactive sexual desire disorder.
    Summary · context
    Patients were randomized 1:1 to 24 weeks of treatment with bremelanotide or placebo.
  3. 03HumanRandomized controlled trialSafety outcome

    In premenopausal women with hypoactive sexual desire disorder, nausea was more frequent with bremelanotide than with placebo, at 10% or more in both studies.

    In plain wordsMore women had nausea with bremelanotide than with placebo in two trials.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    IncreaseNausea
    Study

    n = 1,247

    Comparator
    Placebo
    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    1.75 mg · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    Nausea incidence
    ≥ 10%
    bremelanotide, both studies

    Source sentences

    Summary
    Patients taking bremelanotide experienced more nausea, flushing, and headache (10% or more in both studies) compared with placebo.
    2 context sentences
    Summary · context
    Two identical phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trials (RECONNECT) evaluated the safety and efficacy of bremelanotide 1.75 mg administered subcutaneously as needed in premenopausal women with hypoactive sexual desire disorder.
    Summary · context
    Patients were randomized 1:1 to 24 weeks of treatment with bremelanotide or placebo.
  4. 04HumanRandomized controlled trialSafety outcome

    In premenopausal women with hypoactive sexual desire disorder, flushing was more frequent with bremelanotide than with placebo, at 10% or more in both studies.

    In plain wordsMore women had flushing with bremelanotide than with placebo in two trials.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    IncreaseFlushing
    Study

    n = 1,247

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    1.75 mg · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    Flushing incidence
    ≥ 10%
    bremelanotide, both studies

    Source sentences

    Summary
    Patients taking bremelanotide experienced more nausea, flushing, and headache (10% or more in both studies) compared with placebo.
    2 context sentences
    Summary · context
    Two identical phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trials (RECONNECT) evaluated the safety and efficacy of bremelanotide 1.75 mg administered subcutaneously as needed in premenopausal women with hypoactive sexual desire disorder.
    Summary · context
    Patients were randomized 1:1 to 24 weeks of treatment with bremelanotide or placebo.
  5. 05HumanRandomized controlled trialSafety outcome

    In premenopausal women with hypoactive sexual desire disorder, headache was more frequent with bremelanotide than with placebo, at 10% or more in both studies.

    In plain wordsMore women had headache with bremelanotide than with placebo in two trials.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    IncreaseHeadache
    Study

    n = 1,247

    Comparator
    Placebo
    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    1.75 mg · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    Headache incidence
    ≥ 10%
    bremelanotide, both studies

    Source sentences

    Summary
    Patients taking bremelanotide experienced more nausea, flushing, and headache (10% or more in both studies) compared with placebo.
    2 context sentences
    Summary · context
    Two identical phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trials (RECONNECT) evaluated the safety and efficacy of bremelanotide 1.75 mg administered subcutaneously as needed in premenopausal women with hypoactive sexual desire disorder.
    Summary · context
    Patients were randomized 1:1 to 24 weeks of treatment with bremelanotide or placebo.
  6. 06HumanRandomized controlled trialSafety outcome

    In premenopausal women with hypoactive sexual desire disorder, most treatment-emergent adverse events with bremelanotide were related to tolerability and were mild or moderate in intensity.

    In plain wordsIn two trials of bremelanotide in premenopausal women, most side effects were mild or moderate.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Not applicableSeverity of treatment-emergent adverse events
    Study

    n = 1,247

    Outcome group
    Adverse events · Whole body
    Studied dose
    1.75 mg · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Most treatment-emergent adverse events were related to tolerability and the majority were mild or moderate in intensity.
    2 context sentences
    Summary · context
    Two identical phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trials (RECONNECT) evaluated the safety and efficacy of bremelanotide 1.75 mg administered subcutaneously as needed in premenopausal women with hypoactive sexual desire disorder.
    Summary · context
    Patients were randomized 1:1 to 24 weeks of treatment with bremelanotide or placebo.

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

Registered trials3

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

3 trials · 3 completed · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4Results postedNCT04179734

Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder

Imperial College Healthcare NHS Trustn = 407 Oct 2019 to 6 Oct 2020

Hypoactive Sexual Desire Disorder

Trial pageClinicalTrials.govUpdated 9 Aug 2024
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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