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A Twenty-eight Week Safety, Extension Study of Flibanserin to Treat Premenopausal and Postmenopausal Women With Hypoactive Sexual Desire Disorder

2014-08-27 03:14:34 | BioPortfolio

Summary

To generate additional long-term safety and efficacy data on flibanserin in premenopausal women and establish long-term safety and tolerability of flibanserin in naturally postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior clinical trial of flibanserin (Trial 511.130, 511.147, or 511.156).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Sexual Dysfunctions, Psychological

Intervention

flibanserin

Location

511.133.01074 Boehringer Ingelheim Investigational Site
Birmingham
Alabama
United States

Status

Recruiting

Source

Boehringer Ingelheim Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:34-0400

Clinical Trials [624 Associated Clinical Trials listed on BioPortfolio]

A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).

To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness of Flibanserin in Women with HSDD that have already completed a previous study (511.70/71/.74...

Flibanserin Randomized Withdrawal Trial in Pre-Menopausal Women

To estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment.

6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA

This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meet standard diagnostic ...

24-Week Placebo-Controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder

This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire (HSDD) that meets standard diagnostic criteri...

A Twenty Four Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard diagnostic...

PubMed Articles [3548 Associated PubMed Articles listed on BioPortfolio]

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...

The Relevance of Sexual Concerns and Adult Attachment for Sexual Functioning.

Sexual dysfunctions are highly prevalent and often associated with negative sexual attitudes such as sexual myths and sexual concerns. The aim of this paper was to explore the relationships between se...

Sexual function of undergraduate women: a comparative study between Brazil and Italy.

to evaluate the sexual function of Italian and Brazilian nursing students using the Female Sexual Function Index (FSFI), to estimate the prevalence of sexual dysfunctions and related factors.

Postcoital Dysphoria: Prevalence and Correlates among Males.

Consensual sexual activity is believed to be associated with a positive emotional experience, however, Postcoital Dysphoria (PCD) is a counter-intuitive phenomenon characterized by inexplicable feelin...

Psychometric validation of the Portuguese version of the Massachusetts General Hospital - Sexual Functioning Questionnaire.

Sexual dysfunctions are a high prevalence health problem, making it necessary to provide assessment instruments adapted to the Portuguese population.

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).

The processes of anatomical and physiological changes related to sexual or reproductive functions during the life span of a human or an animal, from FERTILIZATION to DEATH. These processes include SEX DIFFERENTIATION; SEXUAL MATURATION; and changes during AGING.

This discipline concerns the study of SEXUALITY, and the application of sexual knowledge such as sexual attitudes, psychology, and SEXUAL BEHAVIOR. Scope of application generally includes educational (SEX EDUCATION), clinical (SEX COUNSELING), and other settings.

A pattern of assaultive and coercive behavior by an individual against their partner or spouse that may include physical injury, psychological abuse, sexual assault, progressive isolation, stalking, deprivation, intimidation, and reproductive coercion.

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