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

TERMINATEDPHASE3

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

Worldwide One-year Open-label Safety Study of Flibanserin in Women With HSDD

NCT00441558•Sprout Pharmaceuticals, Inc

View on ClinicalTrials.gov

Summary

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/.75/.105) with Flibanserin.

Eligibility

Age

18 - 55 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Women with a primary diagnosis of HSDD who have completed a previous study of Flibanserin.
•2. Patients must have used a medically acceptable method of contraception for at least 2 months before the start of the study and continue to use that method for the duration of the study.
•3. Patients must be reliable, compliant, and agree to cooperate with all study evaluations.
•4. Patients must be able and willing to give meaningful, written informed consent prior to the start of the study and be willing to discuss their sexual functioning with the study staff.

Exclusion Criteria

•1. A history of Major Depressive Disorder within 6 months prior to the start of the study, current suicidal thoughts, or any history of a suicide attempt.
•2. Participation in another clinical trial within 1 month prior to the start of the study, except for Flibanserin.
•3. Patients with pelvic inflammatory disease, urinary tract infection, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
•4. Patients who are pregnant or have been pregnant within 1 month prior to study start.
•5. Patients experiencing major life stress (including loss of income, death of a family member, major illness, etc.) or relationship trouble that could interfere with sexual activity, except distress about HSDD.
•6. Clinically significant ECG or lab abnormalities at study start.
•7. Patients taking prohibited medications that were excluded in their previous trial which contribute to sexual dysfunction or safety-related interactions.

Locations (196)

511.84.01079 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

511.84.01193 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

511.84.01188 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

511.84.01110 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

511.84.01142 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

511.84.01157 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

511.84.01162 Boehringer Ingelheim Investigational Site

Little Rock, Alaska, United States

511.84.01070 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

511.84.01191 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

511.84.01115 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Key Dates

Start Date

February 1, 2007

Primary Completion Date

August 1, 2009

Completion Date

August 1, 2009

Last Updated

June 13, 2014

Enrollment

1,723

ACTUAL participants

Conditions

Sexual Dysfunctions, Psychological

Interventions

Flibanserin

DRUG

Sexual Function Changes in High-Risk Pregnancies

NCT05093647

Sexual Dysfunctions, PsychologicalHigh Risk Pregnancy+1 more

View study

COMPLETEDPHASE2

Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men

NCT02593396

Sexual Dysfunctions, PsychologicalHypoactive Sexual Desire Disorder+1 more

View study

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: June 13, 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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A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).

Inclusion Criteria

Exclusion Criteria

Sexual Function Changes in High-Risk Pregnancies

Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men

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

Sexual Health on Antidepressants Through Physical Exercise

Pharmacokinetics of Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)

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