Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.

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Key information

Conditions

Sexual Dysfunctions, Psychological Mental Disorders

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

511.147.01074 Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Premenopausal women who are 18 years old and older
Primary diagnosis of hypoactive sexual desire disorder, generalized acquired type according to Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision, at least 24 weeks in duration.
Stable, monogamous heterosexual relationship for at least one year.
Willing to discuss sexual issues.
Willing to engage in sexual activity at least once a month
Normal pap smear
Must use medically acceptable method of contraception
Able to comply with daily use of a handheld entry device

Exclusion criteria

Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit.
Patients who meet Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision for: Sexual aversion disorder, substance induced sexual dysfunction, Dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual dysfunction do to a general medical condition.
Partner with inadequately treated organic or psychosexual dysfunction
History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior.
Sexual function impaired by psychiatric disorder
Sexual function impaired by gynecological disorder
Major life stress that could impair sexual function
Substance abuse

Treatment and study plan

flibanserin

Drug

patients will be randomized to flibanserin or placebo in a double-blind manner

Placebo

Drug

patients will be randomized to flibanserin or placebo in a double-blind manner

Primary outcomes

The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.

Time frame: 24 weeks

The FSFI is a self-administered questionnaire for assessing key dimensions of sexual function in women. The scale consists of 19 items assessing sexual function over the past 4 weeks and yields scores in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The 2 items in the desire domain are scored from '1' to '5'. The raw scores of the 2 items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0. The higher the score on the desire domain, the higher the level of reported sexual desire.
Change From Baseline in the SSE Count From Baseline to 24 Weeks

Time frame: 24 weeks

The change from baseline in the number of Satisfying Sexual Events (SSEs) as measured by the eDiary. The SSEs will be standardized to a 28-day period according to the below formula:

Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered).

"Satisfying" means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.

An eDiary was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.

Sponsors and collaborators

Lead sponsor

Sprout Pharmaceuticals, Inc

Industry

Registry information

Official study title

A Twenty-four Week, Randomized, Double-blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin (100 Milligrams) Administered Orally Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder in the United States

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2011
First posted: Oct 16, 2009
Registry last updated: May 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed