Overview

This trial is active, not recruiting.

Condition hypoactive sexual desire disorder
Treatments bremelanotide, placebo
Phase phase 3
Sponsor Palatin Technologies
Collaborator PRA Health Sciences
Start date January 2015
End date August 2016
Trial size 714 participants
Trial identifier NCT02338960, BMT-302, Reconnect Study

Summary

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
bremelanotide BMT
A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
(Placebo Comparator)
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
Placebo

Primary Outcomes

Measure
Efficacy of a fixed dose of bremelanotide as measured by FSFI (Question Q1 and Q2), 28-day recall.
time frame: 32 weeks
Efficacy of a fixed dose of bremelanotide as measured by FSDS-DAO (item 13)
time frame: 32 weeks

Secondary Outcomes

Measure
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: 32 weeks
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
time frame: 32 weeks
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
time frame: 32 weeks
Efficacy of a fixed dose of bremelanotide, as measured by the change in baseline to End of Study in the FSDS-DAO total score
time frame: 32 weeks
Efficacy of a fixed dose of bremelanotide, as measured by the change in baseline to End of Study in the FSFI total score
time frame: 32 weeks
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
time frame: 32 weeks
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
time frame: 32 weeks
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
time frame: 32 weeks
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)
time frame: 32 weeks
Efficacy of a fixed dose of bremelanotide, as measured by the change in baseline to End of Study in the total number of SSEs
time frame: 32 weeks
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
time frame: 32 weeks
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
time frame: 32 weeks
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
time frame: 32 weeks

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

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)
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) a 32-week phase including a randomized, double-blind treatment period preceded by a screening/baseline period (Core Study) and (2) a 52 week open-label treatment phase (Extension Phase). 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Palatin Technologies.