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

Stopped early · Phase 3

Conditions studied: Sexual Dysfunctions, Psychological

In brief

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.

Key facts

Study ID

NCT00441558

Run by

Sprout Pharmaceuticals, Inc

People needed

1723

Starts

2007-02-01

Expected to finish

2009-08-01

Last updated by the study team

2014-06-13

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women with a primary diagnosis of HSDD who have completed a previous study of Flibanserin.
• 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.
• Patients must be reliable, compliant, and agree to cooperate with all study evaluations.
• 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.

You may not qualify if…

• 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.
• Participation in another clinical trial within 1 month prior to the start of the study, except for Flibanserin.
• Patients with pelvic inflammatory disease, urinary tract infection, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
• Patients who are pregnant or have been pregnant within 1 month prior to study start.
• 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.
• Clinically significant ECG or lab abnormalities at study start.
• Patients taking prohibited medications that were excluded in their previous trial which contribute to sexual dysfunction or safety-related interactions.

Where it is running

• 511.84.01193 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
• 511.84.01188 Boehringer Ingelheim Investigational Site — Huntsville, Alabama, United States
• 511.84.01110 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
• 511.84.01142 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
• 511.84.01157 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
• 511.84.01162 Boehringer Ingelheim Investigational Site — Little Rock, Alaska, United States
• 511.84.01070 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 511.84.01191 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 511.84.01115 Boehringer Ingelheim Investigational Site — Tucson, Arizona, United States
• 511.84.01013 Boehringer Ingelheim Investigational Site — Jonesboro, Arkansas, United States
• 511.84.01087 Boehringer Ingelheim Investigational Site — Berkeley, California, United States
• 511.84.01077 Boehringer Ingelheim Investigational Site — Encinitas, California, United States
• 511.84.01074 Boehringer Ingelheim Investigational Site — Fair Oaks, California, United States
• 511.84.01104 Boehringer Ingelheim Investigational Site — Irvine, California, United States
• 511.84.01037 Boehringer Ingelheim Investigational Site — La Jolla, California, United States
• 511.84.01056 Boehringer Ingelheim Investigational Site — Sacramento, California, United States
• 511.84.01195 Boehringer Ingelheim Investigational Site — Sacramento, California, United States
• 511.84.01043 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 511.84.01047 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 511.84.01096 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 511.84.01040 Boehringer Ingelheim Investigational Site — Stanford, California, United States
• 511.84.01048 Boehringer Ingelheim Investigational Site — Tarzana, California, United States
• 511.84.01017 Boehringer Ingelheim Investigational Site — Torrance, California, United States
• 511.84.01173 Boehringer Ingelheim Investigational Site — Vista, California, United States
• 511.84.01079 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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