Advertisement

Topics

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Extension

2015-05-04 16:38:21 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Hypoactive Sexual Desire Disorder

Intervention

Bremelanotide, Placebo

Location

Palatin Clinical Site 242
Birmingham
Alabama
United States
35242

Status

Recruiting

Source

Palatin Technologies

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-05-04T16:38:21-0400

Clinical Trials [1610 Associated Clinical Trials listed on BioPortfolio]

BP101 for Adults With Female Sexual Dysfunction

This study is to confirm efficacy and safety of study drug BP101 in female patients with with decrease or loss of sexual desire, which is equal to acquired generalized hypoactive sexual de...

Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in p...

Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)

The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.

Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study

The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.

Flibanserin and EEG in Females With Hypoactive Sexual Desire Disorder

The purpose of the present study is to understand the neurobiological mechanisms of action underlying sexual desire building on prior work Dr. Stephanie Cacioppo has done in which desire w...

PubMed Articles [6986 Associated PubMed Articles listed on BioPortfolio]

Clinical management of hypoactive sexual desire disorder.

Although a woman's healthcare provider has the best opportunity to address hypoactive sexual desire disorder (HSDD), most women are reluctant to discuss their loss of sexual desire. The feeling is oft...

Trazodone in Sexual Medicine: Underused and Overdosed?

Treatment of hypoactive sexual desire disorder (HSDD) remains unfulfilled. The only approved medication, flibanserin (FLI), is highly underused owing to concerns about central nervous system (CNS) dep...

Attachment, Sexual Desire, and Object of Desire Self-Consciousness Trade-Up Effects.

Using spectral and cross-spectral analysis to identify patterns and synchrony in couples' sexual desire.

Sexual desire discrepancy is one of the most frequently reported sexual concerns for individuals and couples and has been shown to be negatively associated with sexual and relationship satisfaction. S...

Broadening your horizons: Self-expanding activities promote desire and satisfaction in established romantic relationships.

In the early stages of romantic relationships, sexual desire is often intense, but over time, as partners get to know each other, desire tends to decline. Low sexual desire has negative implications f...

Medical and Biotech [MESH] Definitions

Disturbances in sexual desire and the psychophysiologic changes that characterize the sexual response cycle and cause marked distress and interpersonal difficulty. (APA, DSM-IV, 1994)

A sexual disorder occurring in a person 16 years or older and that is recurrent with intense sexually arousing fantasies, sexual urges, or behaviors involving sexual activity with a prepubescent child (generally age 13 or younger). (from APA, DSM-IV, 1994).

A personality disorder manifested by a profound defect in the ability to form social relationships, no desire for social involvement, and an indifference to praise or criticism.

Full gratification of a need or desire followed by a state of relative insensitivity to that particular need or desire.

A disorder in which fantasies about or the act of exposing the genitals to an unsuspecting stranger produces sexual excitement with no attempt at further sexual activity with the stranger.

More From BioPortfolio on "A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Extension"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Sexual Health
The World Health Organization (WHO) definition of sexual health; "the state of physical, emotional, mental and social well-being related to sexuality; it is not merely the absence of disease, dysfunction and infirmity. Sexual health requires a posit...

Urology
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...


Searches Linking to this Trial