Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

Phase 3

Completed

• Conditions: Sexual Dysfunctions, Psychological

• Registration Number: NCT00277914
• Lead Sponsor: Sprout Pharmaceuticals, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-16
• Study First Submitted QC: 2006-01-16
• Study First Posted: 2006-01-18
• Primary Completion: 2007-07
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-14
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 749

Inclusion Criteria

1. Women over 18 and pre-menopausal
2. FSDS-R above 14
3. Willingness to try to have sexual activity at least monthly
4. Willingness to use an electronic diary daily
5. Stable, monogamous, heterosexual relationship for at least one year
6. Medically acceptable method of contraception

Exclusion Criteria

1. Clinically relevant conditions which might interfere with the patient's abil ity to participate in the trial
2. Specified medications
3. Sexual function affected by medication
4. Drug dependence or abuse
5. Sexual partner needing treatment
6. Peri-Menopause or Menopause (surgical or otherwise)
7. Pregnancy
8. Pelvic Inflammatory Disease
9. Major depressive Episode
10. Significant ECG abnormalities
11. Significant Neurologic findings
12. Significant GI, Hepatic, Cardiovascular, Renal, Hematologic, Immunologic or Respiratory findings
13. Uncorrected thyroid or endocrine disease
14. Uncontrolled Glaucoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Duration of efficacy of flibanserin in Sexually Satisfying Events	24 weeks

Trial Locations

Locations (65)

511.74.01051 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

511.74.01027 Boehringer Ingelheim Investigational Site; 🇺🇸 Mobile, Alabama, United States

511.74.01029 Boehringer Ingelheim Investigational Site; 🇺🇸 Scottsdale, Arizona, United States

511.74.01031 Boehringer Ingelheim Investigational Site; 🇺🇸 Tucson, Arizona, United States

511.74.01004 Boehringer Ingelheim Investigational Site; 🇺🇸 Jonesboro, Arkansas, United States

511.74.01053 Boehringer Ingelheim Investigational Site; 🇺🇸 Little Rock, Arkansas, United States

511.74.01033 Boehringer Ingelheim Investigational Site; 🇺🇸 Palm Springs, California, United States

511.74.01003 Boehringer Ingelheim Investigational Site; 🇺🇸 Palo Alto, California, United States

511.74.01015 Boehringer Ingelheim Investigational Site; 🇺🇸 Sacramento, California, United States

511.74.01013 Boehringer Ingelheim Investigational Site; 🇺🇸 San Diego, California, United States

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