Other Clinical Trial - 1. Study to Evaluate the Efficacy/Safety of

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Disease
Hypoactive Sexual Desire Disorder
Hypokinesia
Sexual Dysfunctions, Psychological

Clinical Trial Details

NCT number	NCT02333071
Study type	Interventional
Source	Palatin Technologies
Contact
Status	Completed
Phase	Phase 3
Start date	December 2014
Completion date	June 30, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02430987` - Low Sexual Desire and Metabolic Syndrome	N/A
Completed	`NCT01432665` - Lybrido for Female Sexual Dysfunction	Phase 2
Terminated	`NCT00551785` - Surveillance Study of Women Taking Intrinsa®	Phase 4
Completed	`NCT03232801` - A Mindfulness-based Intervention for Older Women With Low Sexual Desire	N/A
Recruiting	`NCT04179734` - Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder	Phase 4
Terminated	`NCT02770768` - Effects of Flibanserin on the Pre- and Post-menopausal Female Brain	N/A
Completed	`NCT01235754` - Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)	Phase 3
Completed	`NCT03287232` - Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)	Phase 3
Completed	`NCT00384046` - Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen	Phase 3
Completed	`NCT00331123` - Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido	Phase 3
Recruiting	`NCT04943068` - A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)	Phase 3
Completed	`NCT03463707` - BP101 for Adults With Female Sexual Dysfunction	Phase 3
Completed	`NCT01208038` - Testosterone Patch's Effects on the Cardiovascular System and Libido	Phase 4
Completed	`NCT00657501` - Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women	Phase 3
Completed	`NCT04336891` - Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.
Completed	`NCT01382719` - Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder	Phase 2
Recruiting	`NCT00916396` - Dehydroepiandrosterone (DHEA) Treatment in Women and Men Experiencing Hypoactive Sexual Desire Disorder	N/A
Completed	`NCT00338312` - Study of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido	Phase 3
Completed	`NCT00331214` - Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido	Phase 3
Completed	`NCT00034021` - Ginkgo Biloba: Antidepressant-Induced Sexual Dysfunction	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms