Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sprout Pharmaceuticals, Inc

Criteria

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