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CompletedNCT02338960HSDDUpdated Jan 28, 2021Results posted

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

A Phase 3 interventional study of Bremelanotide and Placebo in Hypoactive Sexual Desire Disorder, sponsored by Palatin Technologies, Inc. Completed at 91 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-28.

Sponsored by Palatin Technologies, Inc · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
714
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the detailed description

This will be a multicenter, randomized, placebo-controlled, parallel group study in up to 80 sites in the United States of America (USA) and Canada to evaluate the efficacy and safety of a fixed dose of SC BMT versus placebo on an as-needed basis under conditions of home use in premenopausal women with HSDD (with or without decreased arousal).

The study will consist of 2 phases: (1) Core Study: 4-week no-treatment qualification period, a 4-week single-blind placebo treatment period (baseline), and a 24-week double-blind treatment period where participants will self-administer placebo or BMT 1.75 mg SC via an autoinjector; and (2) Extension Phase: a 52-week open-label treatment period during which all subjects will receive BMT 1.75 mg.

Primary Objective

  • 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.

Secondary Objectives

  • To evaluate the efficacy of BMT in premenopausal women in the double-blind Core Study, as assessed by subject responses to questionnaires measuring sexual function, treatment satisfaction, and distress associated with sexual dysfunction.
  • To evaluate the safety of BMT in premenopausal women in the double-blind Core Study.
  • To evaluate the safety of long-term therapy with BMT in the open label Extension Phase.
  • To evaluate the efficacy of long-term therapy with BMT in the open-label Extension Phase.
02

Conditions studied

  • Hypoactive Sexual Desire Disorder

Keywords

  • HSDD Female
  • Sexual Desire Disorder
  • decreased desire
  • female sexual dysfunction
03

In context

Hypokinesia

84 studies on the registry are indexed under Hypokinesia; 10 are open to participants now.

This study's enrollment of 714 is above the median of 60 across 65 interventional studies indexed under Hypokinesia.

Browse Hypokinesia studies →

Lead sponsor

Palatin Technologies, Inc is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
714 participants (actual)

Study arms

  • 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

    Drug: Bremelanotide

  • 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

    Drug: Bremelanotide · Drug: Placebo

Interventions

  • DrugBremelanotide

    A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)

    Also known as: BMT, PT-141

  • DrugPlacebo

    Placebo

    Also known as: PBO

06

What researchers measure

Primary outcomes

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

    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 This score is on a scale ranging from 1.2 to 6. A higher score on this scale represent an increase in sexual desire and is a better outcome.

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

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

    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 (item 13). Responses range from 0 (never) to 4 (always). Lower scores on this scale represent an increase in sexual desire and indicate a better outcome. Higher scores indicate a worse outcome.

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

Secondary outcomes

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

    Mean change from Baseline to end of study (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 indicates a better outcome.

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

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

    FSEP-R=Female Sexual Encounter Profile - Revised Scores on this scale range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where an increase in value indicates a better outcome.

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

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

    FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.

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

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

    FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm. The FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. All responses are on a scale ranging from 0 ("never") to 4 ("always"). Total Scores range from 0 (never feel bothered) to 60 (always feel bothered). Decreased scores indicate improvement. A higher score on this scale indicates a worse outcome. The score is the mean change from Baseline observed at EOS (Baseline score - EOS score)

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

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

    Female Sexual Function Index (FSFI) The score is computed programmatically \] resulting in a score on a scale ranging from 1.2 to 6 (Note: OLE: Open-label extension. Scores range from 2 to 36. An improvement in total FSFI score is an increase from baseline. A higher score on this scale represents an increase in sexual desire and is a better outcome.

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

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

    FSEP-R=Female Sexual Encounter Profile - Revised Scores on this scale range from 0 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.

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

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

    FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.

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

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

    FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm. The FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. Scores on this scale range from 0 ("never") to 4 ("always"). Decreased scores indicate improvement. A higher score on this scale indicates a worse outcome.

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

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

    Female Sexual Function Index (FSFI) The score is computed programmatically using the algorithm described by Rosen, resulting in a score ranging from 1.2 to 6. Higher scores on this scale represent an increase in sexual desire and is a better outcome.

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

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

    Change from Baseline to EOS in the total number of satisfying sexual events SSEs. A higher number of events indicates a better outcome.

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

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

    FSFI = Female Sexual Function Index The score is on a scale ranging from 1.2 to 6. A higher score on this scale represents an increase in sexual desire and is a better outcome.

    Time frame: 24 weeks (Main Study)

  12. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Score for Feeling Bothered by Low Sexual Desire as Measured by the FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase

    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"). Decreased scores indicate improvement. A higher score indicates a worse outcome.

    Time frame: 24 weeks (Main Study)

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

    Mean change from Baseline to EOS in the number of satisfying sexual events SSEs associated with study drug administration throughout the entirety of the double-blind phase. A higher number of events indicates a better outcome.

    Time frame: 24 weeks (Main Study)

07

Results

Posted Jan 28, 2021

Participant flow

Core ("Main") Study consisted of a 4-week no drug Screening period, followed by a 4-week single blind PBO period, first dose administered in-clinic. Following the end of single-blind period, which served as Baseline, eligible subjects were then randomized to a 24-week double-blind outpatient treatment period, first dose administered in-clinic.

Core Study
Participant flow — Core Study
MilestonePlacebo PBO/BMTBrememlanotide BMT/BMT
Started306308
Received intervention303301
Completed219173
Not completed87135
Open Label Extension
Participant flow — Open Label Extension
MilestonePlacebo PBO/BMTBrememlanotide BMT/BMT
Started191130
Completed7751
Not completed11479

Outcome measures

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

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 This score is on a scale ranging from 1.2 to 6. A higher score on this scale represent an increase in sexual desire and is a better outcome.

Time frame:
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Reported as:
Mean · score on a scale
Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall.
score on a scaleBremelanotide BMT/BMTPlacebo PBO/BMT
Main study0.63 ± 1.0360.21 ± 0.922
Open label extension1.25 ± 1.1580.70 ± 1.220
PrimaryEfficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13)

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 (item 13). Responses range from 0 (never) to 4 (always). Lower scores on this scale represent an increase in sexual desire and indicate a better outcome. Higher scores indicate a worse outcome.

Time frame:
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Reported as:
Mean · score on a scale
Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13)
score on a scaleBremelanotide BMT/BMTPlacebo PBO/BMT
Main study-0.71 ± 1.145-0.42 ± 1.047
Open label extension-1.4 ± 1.20-0.9 ± 1.07
SecondaryEfficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study (EOS) in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration

Mean change from Baseline to end of study (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 indicates a better outcome.

Time frame:
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Reported as:
Mean · events
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study (EOS) in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration
eventsBremelanotide BMT/BMTPlacebo PBO/BMT
Main study0.0 ± 1.340.0 ± 1.20
Open label extension0.19 ± 1.997-0.31 ± 1.296
SecondaryEfficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in Mean Desire Score (Q3) From the FSEP-R

FSEP-R=Female Sexual Encounter Profile - Revised Scores on this scale range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where an increase in value indicates a better outcome.

Time frame:
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Reported as:
Mean · score on a scale
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in Mean Desire Score (Q3) From the FSEP-R
score on a scaleBremelanotide BMT/BMTPlacebo PBO/BMT
Main study0.04 ± 1.0650.01 ± 0.928
Open label extension0.43 ± 1.0950.33 ± 1.023
SecondaryEfficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R

FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.

Time frame:
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Reported as:
Mean · score on a scale
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R
score on a scaleBremelanotide BMT/BMTPlacebo PBO/BMT
Main study0.27 ± 1.0770.11 ± 0.977
Open label extension0.76 ± 1.1270.47 ± 1.075
SecondaryEfficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSDS-DAO Total Score

FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm. The FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. All responses are on a scale ranging from 0 ("never") to 4 ("always"). Total Scores range from 0 (never feel bothered) to 60 (always feel bothered). Decreased scores indicate improvement. A higher score on this scale indicates a worse outcome. The score is the mean change from Baseline observed at EOS (Baseline score - EOS score)

Time frame:
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Reported as:
Mean · score on a scale
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSDS-DAO Total Score
score on a scaleBremelanotide BMT/BMTPlacebo PBO/BMT
Main study-9.7 ± 13.79-5.6 ± 12.06
Open label extension-18.4 ± 14.06-11.1 ± 14.37
SecondaryEfficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSFI Total Score

Female Sexual Function Index (FSFI) The score is computed programmatically \] resulting in a score on a scale ranging from 1.2 to 6 (Note: OLE: Open-label extension. Scores range from 2 to 36. An improvement in total FSFI score is an increase from baseline. A higher score on this scale represents an increase in sexual desire and is a better outcome.

Time frame:
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Reported as:
Mean · score on a scale
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSFI Total Score
score on a scaleBremelanotide BMT/BMTPlacebo PBO/BMT
Main study2.45 ± 7.3830.84 ± 5.879
Open label extension5.15 ± 7.3013.14 ± 7.281
SecondaryEfficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Mean Level of Sexual Arousal (Q6) From the FSEP-R

FSEP-R=Female Sexual Encounter Profile - Revised Scores on this scale range from 0 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.

Time frame:
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Reported as:
Mean · score on a scale
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Mean Level of Sexual Arousal (Q6) From the FSEP-R
score on a scaleBremelanotide BMT/BMTPlacebo PBO/BMT
Main study0.04 ± 1.068-0.01 ± 0.906
Open label extension0.33 ± 0.9870.35 ± 0.994
SecondaryEfficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Mean Satisfaction With Sexual Arousal (Q7) From the FSEP-R

FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.

Time frame:
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Reported as:
Mean · score on a scale
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Mean Satisfaction With Sexual Arousal (Q7) From the FSEP-R
score on a scaleBremelanotide BMT/BMTPlacebo PBO/BMT
Main study0.23 ± 1.1120.09 ± 0.974
Open label extension0.60 ± 1.1070.47 ± 1.102
SecondaryEfficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Scored Time Spent Being Concerned by Difficulty With Sexual Arousal (Q14) From the FSDS-DAO

FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm. The FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. Scores on this scale range from 0 ("never") to 4 ("always"). Decreased scores indicate improvement. A higher score on this scale indicates a worse outcome.

Time frame:
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Reported as:
Mean · score on a scale
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Scored Time Spent Being Concerned by Difficulty With Sexual Arousal (Q14) From the FSDS-DAO
score on a scaleBremelanotide BMT/BMTPlacebo PBO/BMT
Main study-0.8 ± 1.23-0.4 ± 1.11
Open label extension-1.3 ± 1.11-0.9 ± 1.17
SecondaryEfficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6)

Female Sexual Function Index (FSFI) The score is computed programmatically using the algorithm described by Rosen, resulting in a score ranging from 1.2 to 6. Higher scores on this scale represent an increase in sexual desire and is a better outcome.

Time frame:
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Reported as:
Mean · score on a scale
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6)
score on a scaleBremelanotide BMT/BMTPlacebo PBO/BMT
Main study0.52 ± 1.5350.18 ± 1.254
Open label extension1.19 ± 1.5600.83 ± 1.563
SecondaryEfficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Total Number of SSEs

Change from Baseline to EOS in the total number of satisfying sexual events SSEs. A higher number of events indicates a better outcome.

Time frame:
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Reported as:
Mean · events
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Total Number of SSEs
eventsBremelanotide BMT/BMTPlacebo PBO/BMT
Main study0.0 ± 1.34-0.0 ± 1.20
Open label extension0.25 ± 2.376-0.35 ± 1.655
SecondaryEfficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Desire Domain of the FSFI (Q1 to Q2) Throughout the Entirety of the Double-blind Phase

FSFI = Female Sexual Function Index The score is on a scale ranging from 1.2 to 6. A higher score on this scale represents an increase in sexual desire and is a better outcome.

Time frame:
24 weeks (Main Study)
Reported as:
Mean · score on a scale
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Desire Domain of the FSFI (Q1 to Q2) Throughout the Entirety of the Double-blind Phase
score on a scaleBremelanotide BMTPlacebo PBO
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Desire Domain of the FSFI (Q1 to Q2) Throughout the Entirety of the Double-blind Phase0.78 ± 1.0520.16 ± 0.909
SecondaryEfficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Score for Feeling Bothered by Low Sexual Desire as Measured by the FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase

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"). Decreased scores indicate improvement. A higher score indicates a worse outcome.

Time frame:
24 weeks (Main Study)
Reported as:
Mean · score on a scale
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Score for Feeling Bothered by Low Sexual Desire as Measured by the FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase
score on a scaleBremelanotide BMTPlacebo PBO
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Score for Feeling Bothered by Low Sexual Desire as Measured by the FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase-0.8 ± 1.22-0.4 ± 1.02
SecondaryEfficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Number of SSEs Associated With Study Drug Administration Throughout the Entirety of the Double-blind Phase

Mean change from Baseline to EOS in the number of satisfying sexual events SSEs associated with study drug administration throughout the entirety of the double-blind phase. A higher number of events indicates a better outcome.

Time frame:
24 weeks (Main Study)
Reported as:
Mean · events
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Number of SSEs Associated With Study Drug Administration Throughout the Entirety of the Double-blind Phase
eventsBremelanotide BMTPlacebo PBO
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Number of SSEs Associated With Study Drug Administration Throughout the Entirety of the Double-blind Phase0.1 ± 1.37-0.1 ± 1.28

Adverse events

Collected over 1 year. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Bremelanotide (Main Study)0/303 (0%)3/303 (1%)224/303 (73.9%)
Placebo (Main Study)0/301 (0%)2/301 (0.7%)137/301 (45.5%)
Bremelanotide (OLE)0/130 (0%)1/130 (0.8%)93/130 (71.5%)
Placebo (OLE)0/191 (0%)0/191 (0%)142/191 (74.3%)
Most frequent serious events
Most frequent serious events
EventBremelanotide (Main Study)Placebo (Main Study)Bremelanotide (OLE)Placebo (OLE)
cholecystitisHepatobiliary disorders0/3030/3011/1300/191
Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/3031/3010/1300/191
AnemiaBlood and lymphatic system disorders0/3031/3010/1300/191
PregnancyPregnancy, puerperium and perinatal conditions0/3031/3010/1300/191
Abdominal PainGastrointestinal disorders1/3030/3010/1300/191
PneumoniaInfections and infestations1/3030/3010/1300/191
Gastrointestinal inflammationGastrointestinal disorders1/3030/3010/1300/191
Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/3030/3010/1300/191
Most frequent other events
Showing 10 of 31
Most frequent other events
EventBremelanotide (Main Study)Placebo (Main Study)Bremelanotide (OLE)Placebo (OLE)
NauseaGastrointestinal disorders111/3030/30137/13084/191
FlushingVascular disorders43/3030/30111/13041/191
SunburnInjury, poisoning and procedural complications16/30328/30122/13025/191
HeadacheNervous system disorders38/3034/3019/13029/191
Injection site painGeneral disorders21/30317/3012/1305/191
NasopharyngitisInfections and infestations9/30318/3014/13010/191
Urinary tract infectionInfections and infestations10/3039/3014/13011/191
Injection site reactionGeneral disorders16/3030/3014/1305/191
VomitingGastrointestinal disorders13/3031/3013/1309/191
SinusitisInfections and infestations14/30313/3014/1309/191

Baseline characteristics

Randomized population = 614, of which 10 were not dosed, leaving 604 participants. A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase, including 130 in the BMT group (BMT-BMT) and 191 in the PBO group (PBO-BMT)

Age, Continuous
Age, Continuous(years)Bremelanotide (BMT/BMT)Placebo (PBO/BMT)Total
Main38.5 ± 7.1939.1 ± 6.9638.8 ± 7.08
OLE39.8 ± 7.1239.4 ± 6.5439.6 ± 6.77
Sex: Female, Male
Sex: Female, Male(Participants)Bremelanotide (BMT/BMT)Placebo (PBO/BMT)Total
Main — Female303301604
Main — Male000
OLE — Female130191321
OLE — Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Bremelanotide (BMT/BMT)Placebo (PBO/BMT)Total
Main — Hispanic or Latino212142
Main — Not Hispanic or Latino282280562
Main — Unknown or Not Reported000
OLE — Hispanic or Latino6915
OLE — Not Hispanic or Latino124182306
OLE — Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Bremelanotide (BMT/BMT)Placebo (PBO/BMT)Total
Main — American Indian or Alaska Native213
Main — Asian549
Main — Native Hawaiian or Other Pacific Islander000
Main — Black or African American292958
Main — White263262525
Main — More than one race325
Main — Unknown or Not Reported134
OLE — American Indian or Alaska Native000
OLE — Asian123
OLE — Native Hawaiian or Other Pacific Islander000
OLE — Black or African American101525
OLE — White117171288
OLE — More than one race224
OLE — Unknown or Not Reported011
08

Study locations

91 sites
  • Palatin Clinical Site 242
    Birmingham, Alabama 35242, United States
  • Palatin Clinical Site 218
    Phoenix, Arizona 85032, United States
  • Palatin Clinical Site 254
    Tucson, Arizona 85712, United States
  • Palatin Clinical Site 207
    Hot Springs, Arkansas 71901, United States
  • Palatin Clinical Site 258
    Beverly Hills, California 90210, United States
  • Palatin Clinical Site 256
    Garden Grove, California 92845, United States
  • Palatin Clinical Site 291
    Los Angeles, California 90024, United States
  • Palatin Clinical Site 270
    Oakland, California 94612, United States
  • Palatin Clinical Site 210
    San Diego, California 92120, United States
  • Palatin Clinical Site 251
    San Diego, California 92123, United States
  • Palatin Clinical Site 272
    Sherman Oaks, California 91403, United States
  • Palatin Clinical Site 253
    Tarzana, California 91356, United States
  • Palatin Clinical Site 212
    Denver, Colorado 80209, United States
  • Palatin Clinical Site 219
    Denver, Colorado 80220, United States
  • Palatin Clinical Site 243
    Lakewood, Colorado 80228, United States
  • Palatin Clinical Site 211
    New London, Connecticut 06320, United States
  • Palatin Clinical Site 229
    Waterbury, Connecticut 06708, United States
  • Palatin Clinical Site 202
    Washington, District of Columbia 20036, United States
  • Palatin Clinical Site 204
    Aventura, Florida 33180, United States
  • Palatin Clinical Site 273
    Coral Gables, Florida 33134, United States
  • Palatin Clinical Site 203
    Fort Myers, Florida 33912, United States
  • Palatin Clinical Site 255
    Gainesville, Florida 32607, United States
  • Palatin Clinical Site 266
    Gainesville, Florida 32607, United States
  • Palatin Clinical Site 224
    Jupiter, Florida 33458, United States
  • Palatin Clinical Site 250
    Orlando, Florida 32806, United States
  • Palatin Clinical Site 261
    Oviedo, Florida 32765, United States
  • Palatin Clinical Site 260
    Pinellas Park, Florida 33781, United States
  • Palatin Clinical Site 236
    West Palm Beach, Florida 33409, United States
  • Palatin Clinical Site 248
    Alpharetta, Georgia 30005, United States
  • Palatin Clinical Site 263
    Atlanta, Georgia 30328, United States
  • Palatin Clinical Site 288
    Addison, Illinois 60101, United States
  • Palatin Clinical Site 252
    Chicago, Illinois 60640, United States
  • Palatin Clinical Site 201
    Chicago, Illinois 60654, United States
  • Palatin Clinical Site 277
    Indianapolis, Indiana 46260, United States
  • Palatin Clinical Site 247
    Prairie Village, Kansas 66206, United States
  • Palatin Clinical Site 286
    Paducah, Kentucky 42003, United States
  • Palatin Clinical Site 279
    Lake Charles, Louisiana 70629, United States
  • Palatin Clinical Site 281
    Metairie, Louisiana 70002, United States
  • Palatin Clinical Site 257
    Annapolis, Maryland 21401, United States
  • Palatin Clinical Site 222
    Lutherville, Maryland 21093, United States
  • Palatin Clinical Site 283
    Rockville, Maryland 20852, United States
  • Palatin Clinical Site 265
    Boston, Massachusetts 02131, United States
  • Palatin Clinical Site 217
    New Bedford, Massachusetts 02740, United States
  • Palatin Clinical Site 239
    Kalamazoo, Michigan 49009, United States
  • Palatin Clinical Site 245
    Saginaw, Michigan 48604, United States
  • Palatin Clinical Site 287
    Flowood, Mississippi 39232, United States
  • Palatin Clinical Site 244
    Kansas City, Missouri 64114, United States
  • Palatin Clinical Site 280
    Saint Louis, Missouri 63043, United States
  • Palatin Clinical Site 220
    Lincoln, Nebraska 68510, United States
  • Palatin Clinical Site 290
    Berlin, New Jersey 08009, United States
  • Palatin Clinical Site 233
    Lawrenceville, New Jersey 08648, United States
  • Palatin Clinical Site 276
    Albuquerque, New Mexico 87102, United States
  • Palatin Clinical Site 282
    Rochester, New York 14618, United States
  • Palatin Clinical Site 264
    Cary, North Carolina 27518, United States
  • Palatin Clinical Site 206
    Raleigh, North Carolina 27612, United States
  • Palatin Clinical Site 231
    Salisbury, North Carolina 28144, United States
  • Palatin Clinical Site 209
    Winston-Salem, North Carolina 27103, United States
  • Palatin Clinical Site 271
    Canton, Ohio 44718, United States
  • Palatin Clinical Site 215
    Cincinnati, Ohio 45249, United States
  • Palatin Clinical Site 232
    Cleveland, Ohio 44122, United States
  • Palatin Clinical Site 246
    Columbus, Ohio 43212, United States
  • Palatin Clinical Site 221
    Mayfield Heights, Ohio 44124, United States
  • Palatin Clinical Site 289
    Tiffin, Ohio 44883, United States
  • Palatin Clinical Site 238
    Oklahoma City, Oklahoma 73103, United States
  • Palatin Clinical Site 227
    Oklahoma City, Oklahoma 73112, United States
  • Palatin Clinical Site 267
    Allentown, Pennsylvania 18104, United States
  • Palatin Clinical Site 234
    Philadelphia, Pennsylvania 19114, United States
  • Palatin Clinical Site 240
    Pittsburgh, Pennsylvania 15206, United States
  • Palatin Clinical Site 278
    Lincoln, Rhode Island 02865, United States
  • Palatin Clinical Site 200
    Greer, South Carolina 29650, United States
  • Palatin Clinical Site 259
    Moncks Corner, South Carolina 29461, United States
  • Palatin Clinical Site 275
    Chattanooga, Tennessee 37403, United States
  • Palatin Clinical Site 216
    Jackson, Tennessee 38305, United States
  • Palatin Clinical Site 274
    Memphis, Tennessee 38119, United States
  • Palatin Clinical Site 292
    Nashville, Tennessee 37201, United States
  • Palatin Clinical Site 235
    Arlington, Texas 75230, United States
  • Palatin Clinical Site 230
    Austin, Texas 78731, United States
  • Palatin Clinical Site 223
    Dallas, Texas 75234, United States
  • Palatin Clinical Site 208
    Houston, Texas 77054, United States
  • Palatin Clinical Site 269
    Draper, Utah 84020, United States
  • Palatin Clinical Site 228
    West Jordan, Utah 84088, United States
  • Palatin Clinical Site 284
    Newport News, Virginia 23606, United States
  • Palatin Clinical Site 205
    Norfolk, Virginia 23502, United States
  • Palatin Clinical Site 213
    Richmond, Virginia 23294, United States
  • Palatin Clinical Site 268
    Richmond, Virginia 23298, United States
  • Palatin Clinical Site 214
    Seattle, Washington 98105, United States
  • Palatin Clinical Site 285
    Charleston, West Virginia 25304, United States
  • Palatin Clinical Site 400
    Vancouver, British Columbia V6J 1S3, Canada
  • Palatin Clinical Site 405
    Sudbury, Ontario P3E 1H5, Canada
  • Palatin Clinical Site 401
    Pointe Claire, Quebec H9R 4S3, Canada
  • Palatin Clinical Site 404
    Sherbrooke, Quebec J1H 121, Canada
09

References and documents

Publications

  • Rosen 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. PubMed 10782451 ↗
  • Clayton AH, Kingsberg SA, Portman D, Sadiq A, Krop J, Jordan R, Lucas J, Simon JA. Safety Profile of Bremelanotide Across the Clinical Development Program. J Womens Health (Larchmt). 2022 Feb;31(2):171-182. doi: 10.1089/jwh.2021.0191. PubMed 35147466 ↗
  • Koochaki P, Revicki D, Wilson H, Pokrzywinski R, Jordan R, Lucas J, Williams LA, Sadiq A, Krop J. The Patient Experience of Premenopausal Women Treated with Bremelanotide for Hypoactive Sexual Desire Disorder: RECONNECT Exit Study Results. J Womens Health (Larchmt). 2021 Apr;30(4):587-595. doi: 10.1089/jwh.2020.8460. Epub 2021 Feb 3. PubMed 33538638 ↗
  • Revicki DA, Althof SE, Derogatis LR, Kingsberg SA, Wilson H, Sadiq A, Krop J, Jordan R, Lucas J. Reliability and validity of the elements of desire questionnaire in premenopausal women with hypoactive sexual desire disorder. J Patient Rep Outcomes. 2020 Oct 8;4(1):82. doi: 10.1186/s41687-020-00241-6. PubMed 33033885 ↗
  • Simon JA, Kingsberg SA, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Clayton AH. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstet Gynecol. 2019 Nov;134(5):909-917. doi: 10.1097/AOG.0000000000003514. PubMed 31599847 ↗
  • Kingsberg SA, Clayton AH, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Simon JA. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol. 2019 Nov;134(5):899-908. doi: 10.1097/AOG.0000000000003500. PubMed 31599840 ↗
  • Clayton AH, Lucas J, DeRogatis LR, Jordan R. Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants. Clin Ther. 2017 Mar;39(3):514-526.e14. doi: 10.1016/j.clinthera.2017.01.018. Epub 2017 Feb 9. PubMed 28189361 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02338960
Lead sponsor
Palatin Technologies, Inc
Collaborators
AMAG Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jan 15, 2015
Start date
Jan 2015
Primary completion
Aug 2016
Completion
Jun 29, 2017
Results posted
Jan 28, 2021
Last update
Jan 28, 2021

Study contacts

Robert Jordan
study director · Palatin Technologies, Inc

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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