Loading clinical trials...

Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

Best Tolerability: 50mg Twice Daily Versus 100 mg in the Evening Versus 25 mg Twice Daily Versus Placebo in Younger Women in North America

NCT00360555•Sprout Pharmaceuticals, Inc

View on ClinicalTrials.gov

Summary

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 criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.

Eligibility

Age

18 - 55 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Women who are 18 years of age and older.
•2. Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria.
•3. Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress.
•4. Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
•5. Patients must be willing and able to use an electronic diary on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).
•6. At the Baseline Visit, patients must have complied with eDiary use adequately.
•7. Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 1 year prior to the Screen Visit. The partner is expected to be physically present at least 50% of each month.
•8. Patients must have used a medically acceptable method of contraception for at least 3 months before the Baseline Visit (Visit 2) and continue to use that medically acceptable method of contraception during the trial.
•9. In the investigators opinion, patients must be reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them.
•10. Patients must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must have sufficient understanding to communicate effectively with the investigator, and be willing to discuss their sexual functioning with the investigative staff.
+2 more criteria

Exclusion Criteria

•1. Patients who have taken any medication noted in the protocols List of Prohibited Medications within 30 days before screening.
•2. Patients whose sexual function was affected (enhanced or worsened) in the investigators opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit.
•3. Patients with a history of drug dependence or abuse within the past one year.
•4. Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain.
•5. Patients with a history of participation in a trial of another investigational medication within one month prior to the Screen Visit, or participation in any previous clinical trial of flibanserin.
•6. Patients who meet accepted diagnostic criteria for sexual disorders that would interfere with improvement in HSDD (sexual aversion, substance-induced sexual problems, urge to live as a man, etc.
•7. Patients who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the patients response to treatment.
•8. Patients who have entered the menopausal transition or menopause or have had a hysterectomy.
•9. Patients with findings at the Screen Visit of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female organs.
•10. Patients who are breast feeding or have breastfed within the last 6 months prior to the Baseline Visit.
+4 more criteria

Locations (77)

511.75.01015 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

511.75.01028 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

511.75.01051 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

511.75.01063 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

511.75.01017 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

511.75.01014 Boehringer Ingelheim Investigational Site

Encinitas, California, United States

511.75.01042 Boehringer Ingelheim Investigational Site

Fair Oaks, California, United States

511.75.01022 Boehringer Ingelheim Investigational Site

Irvine, California, United States

511.75.01005 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

511.75.01053 Boehringer Ingelheim Investigational Site

Sacremento, California, United States

Key Dates

Start Date

July 1, 2006

Primary Completion Date

March 1, 2008

Completion Date

March 1, 2008

Last Updated

June 27, 2016

Enrollment

1,584

ACTUAL participants

Conditions

Sexual Dysfunctions, Psychological

Interventions

flibanserin

DRUG

flibanserin 50mg

DRUG

flibanserin 100mg

DRUG

placebo

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 27, 2016Data 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.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Sexual Function Changes in High-Risk Pregnancies

Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men

Sexual Health on Antidepressants Through Physical Exercise

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

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