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Trial · Interventional

CompletedPhase 3Results postedRegistry data

1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

Short name HSDD

NCTNCT02333071 (opens ClinicalTrials.gov in a new tab)Other idBMT-301Other idReconnect Study
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
723 participants (actual)
Sponsor
Palatin Technologies, Inc · Industry
Design
Randomized · Triple masking
Countries
2 countries

United States, Canada

Start
Dec 2014
Primary completion
Jul 2016
Completion
30 Jun 2017
First posted
7 Jan 2015 (estimated)
Last update posted
9 Apr 2021
Conditions
Hypoactive Sexual Desire Disorder

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015201620172018
  1. Ph 3

    HSDD

    NCT02333071

    Dec 2014 to 30 Jun 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.

Interventions

  • BremelanotideDrug
  • PlaceboOther

Arms2

  • Experimental

    Bremelanotide (BMT/BMT)

    (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks

  • Placebo comparator

    Placebo (PBO/BMT)

    (Main Study) PBO administered SC on an as-desired basis for 24 weeks (OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall.

    Time frame · 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

    Registry description

    As measured by change from baseline to end-of-study in the desire domain from the FSFI (Question Q1 and Q2), 28-day recall, co-primary endpoint - FSFI desire domain. FSFI = Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. Its six subscales assess desire, arousal, lubrication, orgasm, satisfaction, and pain, by summing individual items that comprise the subscale and multiplying the sum by a factor, resulting in a score ranging from 1.2 to 6. Increasing scores on this scale represent an increase in sexual desire and is a positive outcome.

  2. Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13)

    Time frame · 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

    Registry description

    As measured by the change from baseline to End-of-Study of the Core Study in the bothered by low desire item from the FSDS-DAO (Female Sexual Distress Scale - Desire Arousal Orgasm) (item 13).: co-primary endpoint - FSDS-DAO bothered by low desire item 13. Responses range from 0 (never) to 4 (always). Decreasing scores on this scale represent an increase in sexual desire (positive outcome).

Secondary outcomes(13)

  1. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration

    Time frame · 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

    Registry description

    Patient's change, from baseline to end of study (EOS), in the number of Satisfying Sexual Events (SSEs), as measured by a response of 'Yes' to question 10 (Q10) of the Female Sexual Encounter Profile-Revised questionnaire (FSEP-R). The end point was calculated as the number of events during the last 4 weeks of treatment with Q10 = Yes minus the number of baseline events with Q10 = Yes.

  2. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in Mean Desire Score (Q3) From FSEP-R

    Time frame · 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

    Registry description

    Scores range from 0 (no desire) to 3 (high desire) for an individual encounter. Change from baseline is computed as the mean of the scores from all encounters for a subject in the last 28 days minus the mean of the scores from all encounters for the subject in the last 28 days before Visit 3. Only FSEP-R data pertaining to encounters recorded within 72 hours of the encounter are included.

  3. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R

    Time frame · 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

    Registry description

    Patient's change, from baseline to end of study (EOS), in mean satisfaction with desire score, as measured by a response to question 4 (Q4) of the Female Sexual Encounter Profile-Revised questionnaire (FSEP-R). Responses range from 1 (Not at all satisfied) to 4 (Completely satisfied).

  4. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the FSDS-DAO Total Score

    Time frame · 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

    Registry description

    FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm Scores range from 0 (never feel bothered) to 60 (always feel bothered).

  5. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total FSFI Total Score

    Time frame · 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

    Registry description

    FSFI = Female Sexual Function Index: a multidimensional self-report instrument for the assessment of female sexual function. The FSFI total score is on a scale ranging from 2 to 36. Increasing scores on this scale represent an increase in sexual desire and is a positive outcome.

  6. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Mean Level of Sexual Arousal (Q6) From the FSEP-R

    Time frame · 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

    Registry description

    FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (not at all aroused) to 3 (highly aroused) for an individual encounter. A higher score indicates a better outcome.

  7. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Mean Satisfaction With Sexual Arousal (Q7) From the FSEP-R

    Time frame · 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

    Registry description

    FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (not at all aroused) to 3 (highly aroused) for an individual encounter. A higher score indicates a better outcome.

  8. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Scored Time Spent Being Concerned by Difficulty With Sexual Arousal (Q14) From the FSDS-DAO

    Time frame · 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

    Registry description

    FSDS-DAO = Female Sexual Distress Scale-Desire/Arousal/Orgasm. The outcome reported is the mean score from the 15-item self assessment. The result is on a scale ranging from 0 ("never") to 4 ("always"). A higher score indicates a worse outcome.

  9. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6)

    Time frame · 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

    Registry description

    FSFI = Female Sexual Function Index: a multidimensional self-report instrument for the assessment of female sexual function. The score is on a scale ranging from 1.2 to 6. Increasing scores on this scale represent an increase in sexual desire and is a better outcome.

  10. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total Number of SSEs

    Time frame · 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

    Registry description

    Change from Baseline to EOS in the total number of satisfying sexual events SSEs that occurred within 16 hours of a study drug dosing and reported within 72 hours. A higher value indicates a better outcome.

  11. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Desire Domain of the FSFI (Q1 to Q2) Throughout the Entirety of the Double-blind Phase

    Time frame · 24 weeks (Main Study)

    Registry description

    FSFI = Female Sexual Function Index: a multidimensional self-report instrument for the assessment of female sexual function. The score is on a scale ranging from 1.2 to 6. Increasing scores on this scale represent an increase in sexual desire and is a positive outcome.

  12. Change From Baseline to End of Study in the Total Score for FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase

    Time frame · 24 weeks (Main Study)

    Registry description

    FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm. The FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. The score is on a scale ranging from 0 ("never") to 4 ("always"). A higher score indicates a worse outcome. The score is the mean change from Baseline observed at EOS (Baseline score - EOS score) for FSDS-DAO Item 13 (feeling bothered by low sexual desire).

  13. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Number of SSEs Associated With Study Drug Administration Throughout the Entirety of the Double-blind Phase

    Time frame · 24 weeks (Main Study)

    Registry description

    Mean change from Baseline to EOS in the number of satisfying sexual events SSEs that occurred within 16 hours of study drug dosing and reported within 72 hours. An increase in number reflects a positive outcome.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall.

GroupValue (score on a scale)Spread
Bremelanotide BMT/BMT0.541.106
Placebo PBO/BMT0.240.994
Primary outcomeMean· 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13)

GroupValue (score on a scale)Spread
Bremelanotide BMT/BMT-0.731.203
Placebo PBO/BMT-0.361.082
Secondary and other outcome results(6)
Secondary outcomeMean· 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration

GroupValue (events)Spread
Bremelanotide BMT/BMT0.01.44
Placebo PBO/BMT-0.11.35
Secondary outcomeMean· 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in Mean Desire Score (Q3) From FSEP-R

GroupValue (score on a scale)Spread
Bremelanotide BMT/BMT0.01.09
Placebo PBO/BMT0.10.92
Secondary outcomeMean· 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R

GroupValue (score on a scale)Spread
Bremelanotide BMT/BMT0.21.15
Placebo PBO/BMT0.00.96
Secondary outcomeMean· 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the FSDS-DAO Total Score

GroupValue (score on a scale)Spread
Bremelanotide BMT/BMT-9.213.86
Placebo PBO/BMT-5.512.27
Secondary outcomeMean· 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total FSFI Total Score

GroupValue (score on a scale)Spread
Bremelanotide BMT/BMT2.697.317
Placebo PBO/BMT0.955.963
Secondary outcomeMean· 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Mean Level of Sexual Arousal (Q6) From the FSEP-R

GroupValue (score on a scale)Spread
Bremelanotide BMT/BMT0.11.11
Placebo PBO/BMT-0.10.93

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Bremelanotide (Main Study)Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks. bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)0 / 3244 / 324255 / 324
Placebo (Main Study)Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours. Placebo: Placebo0 / 3191 / 319160 / 319
Bremelanotide (OLE)Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)0 / 1240 / 12495 / 124
Placebo (OLE)Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours f or 52 weeks. bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)0 / 2392 / 239200 / 239

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies7

Studies that cite this trial.

Studies with results

7 studies on this page

Indexing hint: Review · 2024

3 results

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

Spielmans et al. 2024Journal of sex researchcited by 3

PMID 36809187DOI 10.1080/00224499.2023.2175192PUB-36809187

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Randomized controlled trial · 2022

14 results

Safety Profile of Bremelanotide Across the Clinical Development Program.

Clayton et al. 2022Journal of women's health (2002)cited by 6

PMID 35147466DOI 10.1089/jwh.2021.0191PUB-35147466

Full text at the publisher14 results
Publisher pageSee results (14)

Indexing hint: Randomized controlled trial · 2021

3 results

The Patient Experience of Premenopausal Women Treated with Bremelanotide for Hypoactive Sexual Desire Disorder: RECONNECT Exit Study Results.

Koochaki et al. 2021Journal of women's health (2002)cited by 9

PMID 33538638DOI 10.1089/jwh.2020.8460PUB-33538638

Full text at the publisher3 results
Publisher pageSee results (3)

PubMed tag: none · 2020

1 result

Reliability and validity of the elements of desire questionnaire in premenopausal women with hypoactive sexual desire disorder.

Revicki et al. 2020Journal of patient-reported outcomescited by 5

PMID 33033885PMC7544783DOI 10.1186/s41687-020-00241-6PUB-33033885

CC BY1 result
Download PDFSee results (1)

Indexing hint: Randomized controlled trial · 2019

6 results

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

Kingsberg et al. 2019Obstetrics and gynecologycited by 95

PMID 31599840PMC6819021DOI 10.1097/aog.0000000000003500PUB-31599840

Free to read · publisher termsCC BY-NC-ND6 results
Read at sourceSee results (6)

PubMed tag: none · 2019

9 results

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

Simon et al. 2019Obstetrics and gynecologycited by 30

PMID 31599847PMC6819023DOI 10.1097/aog.0000000000003514PUB-31599847

Free to read · publisher termsCC BY-NC-ND9 results
Read at sourceSee results (9)

Indexing hint: Randomized controlled trial · 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 et al. 2017Clinical therapeuticscited by 10

PMID 28189361DOI 10.1016/j.clinthera.2017.01.018PUB-28189361

Free to read · publisher termsCC BY-NC-ND7 results
Read at sourceSee results (7)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultRosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597. PMID 10782451

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Main Inclusion Criteria: * Has met diagnostic criteria for HSDD for at least 6 months * Is willing and able to understand and comply with all study requirements * Has a normal pelvic examination at screening Main Exclusion Criteria: * Subjects should be generally healthy premenopausal females with no psychological, gynecological or urological conditions which might contribute to the sexual dysfunction, compromise study participation, or confound interpretation of the study results * Not currently under treatment for the sexual dysfunction and willing to forego other treatments through the course of the clinical trial

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