Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

Sprout Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Sexual Dysfunctions, Psychological

Treatments: Drug: Flibanserin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00277914

511.74

Details and patient eligibility

About

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

Enrollment: 749 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)