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Study · Randomized controlled trial · 2024

3 results

Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder.

Spielmans GI, Ellefson EM

Journal of sex research21 Feb 2023Cited by 3 (Europe PMC)

PMID36809187 (opens in a new tab)DOI10.1080/00224499.2023.2175192 (opens in a new tab)PepBankPUB-36809187
Publisher pagePubMedAsk about this study
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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study3

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In re-analysis of previously unpublished RECONNECT trial outcomes in women with HSDD, bremelanotide effect sizes ranged from nil to small.

    In plain wordsIn women with low sexual desire disorder, bremelanotide effects on previously unpublished trial outcomes ranged from none to small.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    MixedPreviously unpublished efficacy outcomes of RECONNECT trials
    Study

    n: not reported in source

    Outcome group
    Sexual function · Reproductive and sexual health
    Studied dose
    Dose not stated

    Source sentences

    Summary
    We analyzed these outcomes, upon which effect sizes ranged from nil to small.
    2 context sentences
    Summary · context
    All efficacy results should be reported, but results on 8 of the 11 clinicaltrials.gov-specified efficacy outcomes were heretofore unpublished (including FSDS-DAO total score, FSFI total score, FSFI arousal domain, and items from the Female Sexual Encounter Profile-Revised).
    Summary · context
    We examined the measurement properties of efficacy measures from the phase III ("RECONNECT") bremelanotide trials for hypoactive sexual desire disorder (HSDD) in women.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In RECONNECT trial data, several other continuous and categorical outcomes showed modest apparent benefits with bremelanotide, nearly all likely derived post hoc.

    In plain wordsIn women with low sexual desire disorder, several other outcomes showed modest apparent benefits with bremelanotide, but nearly all were probably chosen after the fact.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    IncreaseOther continuous and categorical outcomes
    Study

    n: not reported in source

    Outcome group
    Sexual function · Reproductive and sexual health
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Several other continuous and categorical outcomes generated modest apparent benefits, though nearly all of these outcomes were likely derived post-hoc.
    1 context sentence
    Summary · context
    We examined the measurement properties of efficacy measures from the phase III ("RECONNECT") bremelanotide trials for hypoactive sexual desire disorder (HSDD) in women.

Studies that did not test the peptide alone1

In this study, Bremelanotide (PT-141) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Bremelanotide (PT-141).

  1. 03HumanNot a test of Bremelanotide (PT-141) aloneRandomized controlled trialOther

    Validity evidence for the RECONNECT continuous efficacy measures was questionable at best, and none supported the published categorical response outcomes.

    In plain wordsThe questionnaires used in the bremelanotide trials had weak evidence that they measure what they claim to, and the response categories had none.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Not applicableValidity of RECONNECT efficacy measures
    Study

    n: not reported in source

    Outcome group
    Analytical methods and detection · Reproductive and sexual health

    Source sentences

    Summary
    Continuous efficacy outcomes, including a) the Female Sexual Function Index (FSFI) and its Desire domain (FSFI-D) and b) the Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) and its item assessing distress due to low desire (FSDS-DAO #13) have questionable, at best, validity evidence for women with HSDD.
    2 context sentences
    Summary · context
    We found no validity evidence for previously published categorical treatment response outcomes from the RECONNECT trials.
    Summary · context
    We examined the measurement properties of efficacy measures from the phase III ("RECONNECT") bremelanotide trials for hypoactive sexual desire disorder (HSDD) in women.

    In this study, Bremelanotide (PT-141) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Bremelanotide (PT-141).

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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