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

Sprout Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Sexual Dysfunctions, Psychological

Treatments: Drug: Flibanserin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00441558

511.84

Details and patient eligibility

About

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.

Enrollment: 1,723 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,723 participants in 1 patient group

flibanserin

Experimental group

Description:

flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.

Treatment:

Drug: Flibanserin