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Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT00996164•Sprout Pharmaceuticals, Inc

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 55 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Premenopausal women who are 18 years old and older
•2. 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.
•3. Stable, monogamous heterosexual relationship for at least one year.
•4. Willing to discuss sexual issues.
•5. Willing to engage in sexual activity at least once a month
•6. Normal pap smear
•7. Must use medically acceptable method of contraception
•8. Able to comply with daily use of a handheld entry device

Exclusion Criteria

•1. Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit.
•2. 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.
•3. Partner with inadequately treated organic or psychosexual dysfunction
•4. History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior.
•5. Sexual function impaired by psychiatric disorder
•6. Sexual function impaired by gynecological disorder
•7. Major life stress that could impair sexual function
•8. Substance abuse

Locations (75)

511.147.01074 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

511.147.01046 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

511.147.01042 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

511.147.01025 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

511.147.01073 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

511.147.01030 Boehringer Ingelheim Investigational Site

Encinitas, California, United States

511.147.01028 Boehringer Ingelheim Investigational Site

Fair Oaks, California, United States

511.147.01037 Boehringer Ingelheim Investigational Site

Irvine, California, United States

511.147.01022 Boehringer Ingelheim Investigational Site

Sacramento, California, United States

511.147.01035 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Key Dates

Start Date

October 1, 2009

Primary Completion Date

December 1, 2010

Completion Date

February 1, 2011

Last Updated

May 19, 2014

Enrollment

1,090

ACTUAL participants

Conditions

Sexual Dysfunctions, Psychological

Interventions

Flibanserin

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 19, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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