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

Primary Purpose

Hypoactive Sexual Desire Disorder

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Bremelanotide

Placebo

About this trial

This is an interventional treatment trial for Hypoactive Sexual Desire Disorder focused on measuring HSDD Female, Sexual Desire Disorder, decreased desire, female sexual dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bremelanotide (BMT/BMT)

Placebo (PBO/BMT)

Arm Description

(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

(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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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)

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02338960

First Posted

January 12, 2015

Last Updated

January 26, 2021

Sponsor

Palatin Technologies, Inc

Collaborators

AMAG Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02338960

Brief Title

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

Acronym

HSDD

Official Title

Phase 3, Randomized, Double-blind, Placebo-controlled, Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Subcutaneously Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

June 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Palatin Technologies, Inc

Collaborators

AMAG Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoactive Sexual Desire Disorder

Keywords

HSDD Female, Sexual Desire Disorder, decreased desire, female sexual dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

714 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bremelanotide (BMT/BMT)

Arm Type

Experimental

Arm Description

Arm Title

Placebo (PBO/BMT)

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Bremelanotide

Other Intervention Name(s)

BMT, PT-141

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

PBO

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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

Description

Time Frame