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Study · Non-randomized trial · n = 684 · 2019

9 results

Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder.

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

Obstetrics and gynecology1 Nov 2019Cited by 30 (Europe PMC)

PMID31599847 (opens in a new tab)PMCIDPMC6819023 (opens in a new tab)DOI10.1097/aog.0000000000003514 (opens in a new tab)PepBankPUB-31599847
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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 study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    Of 684 patients who enrolled in the open-label extension of bremelanotide, 272 completed it.

    In plain wordsOf 684 women who joined the year-long extension, 272 finished it. The abstract does not give reasons.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Not applicableCompletion of the open-label extension
    Study

    n = 684

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    Participants enrolled
    684 patients
    open-label extension
    Participants completed
    272 patients
    open-label extension

    Source sentences

    Summary
    Of the 856 eligible patients who completed the core phase, 684 elected to participate in the open-label extension, and 272 completed it.
    2 context sentences
    Summary · context
    Women who completed the 24-week double-blind core phase of RECONNECT, composed of two parallel phase 3 trials (301 and 302) examining the safety and efficacy of bremelanotide compared with placebo in premenopausal women with hypoactive sexual desire disorder, could enroll in the 52-week open-label e…
    Summary · context
    All statistical analyses were descriptive.
  2. 02HumanNon-randomized trialSafety outcome

    In the 52-week open-label extension, nausea was the most common treatment-emergent adverse event related to bremelanotide, at 40.4%.

    In plain wordsIn a year-long open-label extension, 40.4% of women taking bremelanotide had nausea related to the drug.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Not applicableNausea (treatment-related)
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    Nausea incidence
    40.4%
    treatment-related, open-label extension

    Source sentences

    Summary
    The most common treatment-emergent adverse events considered related to study drug were nausea (40.4%)
    2 context sentences
    Summary · context
    Women who completed the 24-week double-blind core phase of RECONNECT, composed of two parallel phase 3 trials (301 and 302) examining the safety and efficacy of bremelanotide compared with placebo in premenopausal women with hypoactive sexual desire disorder, could enroll in the 52-week open-label e…
    Summary · context
    All statistical analyses were descriptive.
  3. 03HumanNon-randomized trialSafety outcome

    In the 52-week open-label extension, flushing related to bremelanotide occurred in 20.6%.

    In plain wordsIn a year-long open-label extension, 20.6% of women taking bremelanotide had flushing related to the drug.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Not applicableFlushing (treatment-related)
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    Flushing incidence
    20.6%
    treatment-related, open-label extension

    Source sentences

    Summary
    The most common treatment-emergent adverse events considered related to study drug were nausea (40.4%), flushing (20.6%)
    2 context sentences
    Summary · context
    Women who completed the 24-week double-blind core phase of RECONNECT, composed of two parallel phase 3 trials (301 and 302) examining the safety and efficacy of bremelanotide compared with placebo in premenopausal women with hypoactive sexual desire disorder, could enroll in the 52-week open-label e…
    Summary · context
    All statistical analyses were descriptive.
  4. 04HumanNon-randomized trialSafety outcome

    In the 52-week open-label extension, headache related to bremelanotide occurred in 12.0%.

    In plain wordsIn a year-long open-label extension, about 12% of women taking bremelanotide had headache related to the drug.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Not applicableHeadache (treatment-related)
    Study

    n: not reported in source

    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    Headache incidence
    12%
    treatment-related, open-label extension

    Source sentences

    Summary
    The most common treatment-emergent adverse events considered related to study drug were nausea (40.4%), flushing (20.6%), and headache (12.0%)
    2 context sentences
    Summary · context
    Women who completed the 24-week double-blind core phase of RECONNECT, composed of two parallel phase 3 trials (301 and 302) examining the safety and efficacy of bremelanotide compared with placebo in premenopausal women with hypoactive sexual desire disorder, could enroll in the 52-week open-label e…
    Summary · context
    All statistical analyses were descriptive.
  5. 05HumanNon-randomized trialSafety outcome

    In the open-label extension, nausea was the only severe treatment-emergent adverse event reported by more than one participant in both studies.

    In plain wordsIn a year-long open-label extension of bremelanotide, nausea was the only severe side effect that more than one person had in both studies.

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

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    and the only severe treatment-emergent adverse event experienced by more than one participant in both studies was nausea during the open-label extension.
    2 context sentences
    Summary · context
    Women who completed the 24-week double-blind core phase of RECONNECT, composed of two parallel phase 3 trials (301 and 302) examining the safety and efficacy of bremelanotide compared with placebo in premenopausal women with hypoactive sexual desire disorder, could enroll in the 52-week open-label e…
    Summary · context
    All statistical analyses were descriptive.
  6. 06HumanNon-randomized trialEfficacy outcome

    In women who received bremelanotide in the core phase, the Female Sexual Function Index desire score rose by 1.25 to 1.30 from baseline to the end of the open-label extension.

    In plain wordsIn women treated with bremelanotide in the core phase, desire scores rose over the year-long extension.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    IncreaseFSFI-desire domain change after core-phase bremelanotide
    Study

    n: not reported in source

    Outcome group
    Sexual function · Reproductive and sexual health
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    FSFI-desire change from baseline
    1.25 to 1.3 points
    bremelanotide in core phase

    Source sentences

    Summary
    The change in Female Sexual Function Index-desire domain score and Female Sexual Distress Scale-Desire/Arousal/Orgasm item 13 from baseline to end of the open-label extension ranged from 1.25 to 1.30 and -1.4 to -1.7, respectively, for patients who received bremelanotide during the core phase, and 0…
    2 context sentences
    Summary · context
    Women who completed the 24-week double-blind core phase of RECONNECT, composed of two parallel phase 3 trials (301 and 302) examining the safety and efficacy of bremelanotide compared with placebo in premenopausal women with hypoactive sexual desire disorder, could enroll in the 52-week open-label e…
    Summary · context
    All statistical analyses were descriptive.
  7. 07HumanNon-randomized trialEfficacy outcome

    In women who received bremelanotide in the core phase, the distress score (FSDS-DAO item 13) fell by 1.4 to 1.7 from baseline to the end of the open-label extension.

    In plain wordsIn women treated with bremelanotide in the core phase, distress about low desire fell over the year-long extension.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    DecreaseFSDS-DAO item 13 change after core-phase bremelanotide
    Study

    n: not reported in source

    Outcome group
    Sexual function · Reproductive and sexual health
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    FSDS-DAO item 13 change from baseline
    −1.4 to −1.7 points
    bremelanotide in core phase

    Source sentences

    Summary
    The change in Female Sexual Function Index-desire domain score and Female Sexual Distress Scale-Desire/Arousal/Orgasm item 13 from baseline to end of the open-label extension ranged from 1.25 to 1.30 and -1.4 to -1.7, respectively, for patients who received bremelanotide during the core phase, and 0…
    2 context sentences
    Summary · context
    Women who completed the 24-week double-blind core phase of RECONNECT, composed of two parallel phase 3 trials (301 and 302) examining the safety and efficacy of bremelanotide compared with placebo in premenopausal women with hypoactive sexual desire disorder, could enroll in the 52-week open-label e…
    Summary · context
    All statistical analyses were descriptive.
  8. 08HumanNon-randomized trialEfficacy outcome

    In women who received placebo in the core phase and bremelanotide in the extension, the Female Sexual Function Index desire score rose by 0.70 to 0.77 from baseline.

    In plain wordsIn women who took placebo first and then bremelanotide, desire scores rose over the year-long extension.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    IncreaseFSFI-desire domain change after core-phase placebo
    Study

    n: not reported in source

    Outcome group
    Sexual function · Reproductive and sexual health
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    FSFI-desire change from baseline
    0.7 to 0.77 points
    placebo in core phase

    Source sentences

    Summary
    The change in Female Sexual Function Index-desire domain score and Female Sexual Distress Scale-Desire/Arousal/Orgasm item 13 from baseline to end of the open-label extension ranged from 1.25 to 1.30 and -1.4 to -1.7, respectively, for patients who received bremelanotide during the core phase, and 0…
    2 context sentences
    Summary · context
    Women who completed the 24-week double-blind core phase of RECONNECT, composed of two parallel phase 3 trials (301 and 302) examining the safety and efficacy of bremelanotide compared with placebo in premenopausal women with hypoactive sexual desire disorder, could enroll in the 52-week open-label e…
    Summary · context
    All statistical analyses were descriptive.
  9. 09HumanNon-randomized trialEfficacy outcome

    In women who received placebo in the core phase and bremelanotide in the extension, the distress score (FSDS-DAO item 13) fell by 0.9 from baseline.

    In plain wordsIn women who took placebo first and then bremelanotide, distress about low desire fell over the year-long extension.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    DecreaseFSDS-DAO item 13 change after core-phase placebo
    Study

    n: not reported in source

    Outcome group
    Sexual function · Reproductive and sexual health
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    FSDS-DAO item 13 change from baseline
    −0.9 points
    placebo in core phase

    Source sentences

    Summary
    The change in Female Sexual Function Index-desire domain score and Female Sexual Distress Scale-Desire/Arousal/Orgasm item 13 from baseline to end of the open-label extension ranged from 1.25 to 1.30 and -1.4 to -1.7, respectively, for patients who received bremelanotide during the core phase, and 0…
    2 context sentences
    Summary · context
    Women who completed the 24-week double-blind core phase of RECONNECT, composed of two parallel phase 3 trials (301 and 302) examining the safety and efficacy of bremelanotide compared with placebo in premenopausal women with hypoactive sexual desire disorder, could enroll in the 52-week open-label e…
    Summary · context
    All statistical analyses were descriptive.

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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