Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder
Sexual Dysfunctions, Psychological
About this trial
This is an interventional treatment trial for Sexual Dysfunctions, Psychological
Eligibility Criteria
Inclusion Criteria:
- Women with a primary diagnosis of HSDD who still needs to be treated according to the investigator's opinion and willing to continue in this study. This continuation requires adequate compliance, in the Investigators judgement, with trial medication and the trial visit required in the parent clinical trial (Visit 1 to visit 9).
- Patients must have used a medically acceptable method of contraception [i.e., double barrier method (e.g., diaphragm or condom and spermicide), hormonal therapy (subcutaneous, injectable, intra-vaginal, or oral contraceptive), intrauterine device, tubal sterilization, or partner's surgical sterilization] for at least 3 months before the Screen Visit and continue to use that medically acceptable method of contraception during the trial.
Exclusion Criteria:
- Patients with a history of MDD within 6 months prior the Screen Visit or a score of 14 on the Beck Depression Inventory II, or a history of suicide attempt according to the Beck Scale for Suicide Ideation, or patient with any non-zero statement in the first five items for the Beck Scale for Suicide Ideation.
- Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Inclusion Visit.
- Patients with findings at the Screen Visit of pelvic inflammatory disease, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
- Patients experiencing major life stress (including parenting pressure, eldercare, loss of income, death of a family member, etc.) or relationship discord that could interfere with sexual activity, except distress about HSDD.
- Clinically significant ECG abnormalities at the Screen Visit, according to the investigators opinion or the cardiologist who have performed the ECG. The following ECG values are considered to be exclusionary: QTc intervals >480 milliseconds (ms), PR intervals >240 ms, and QRS intervals >110 ms.
Sites / Locations
- 511.118.43005 Boehringer Ingelheim Investigational Site
- 511.118.43002 Boehringer Ingelheim Investigational Site
- 511.118.43004 Boehringer Ingelheim Investigational Site
- 511.118.43006 Boehringer Ingelheim Investigational Site
- 511.118.32004 Boehringer Ingelheim Investigational Site
- 511.118.32003 Boehringer Ingelheim Investigational Site
- 511.118.32005 Boehringer Ingelheim Investigational Site
- 511.118.32006 Boehringer Ingelheim Investigational Site
- 511.118.32002 Boehringer Ingelheim Investigational Site
- 511.118.42001 Boehringer Ingelheim Investigational Site
- 511.118.42002 Boehringer Ingelheim Investigational Site
- 511.118.42003 Boehringer Ingelheim Investigational Site
- 511.118.42004 Boehringer Ingelheim Investigational Site
- 511.118.35801 Boehringer Ingelheim Investigational Site
- 511.118.35805 Boehringer Ingelheim Investigational Site
- 511.118.35802 Boehringer Ingelheim Investigational Site
- 511.118.35803 Boehringer Ingelheim Investigational Site
- 511.118.35804 Boehringer Ingelheim Investigational Site
- 511.118.3308A Boehringer Ingelheim Investigational Site
- 511.118.3301A Boehringer Ingelheim Investigational Site
- 511.118.3305A Boehringer Ingelheim Investigational Site
- 511.118.3314A Boehringer Ingelheim Investigational Site
- 511.118.3314B Cabinet médical
- 511.118.3303A Boehringer Ingelheim Investigational Site
- 511.118.3310A Boehringer Ingelheim Investigational Site
- 511.118.3312A Boehringer Ingelheim Investigational Site
- 511.118.3315A Cabinet Médical
- 511.118.3306A Boehringer Ingelheim Investigational Site
- 511.118.3311A Boehringer Ingelheim Investigational Site
- 511.118.49004 Boehringer Ingelheim Investigational Site
- 511.118.49001 Boehringer Ingelheim Investigational Site
- 511.118.49006 Boehringer Ingelheim Investigational Site
- 511.118.49008 Boehringer Ingelheim Investigational Site
- 511.118.49003 Boehringer Ingelheim Investigational Site
- 511.118.49002 Boehringer Ingelheim Investigational Site
- 511.118.49005 Boehringer Ingelheim Investigational Site
- 511.118.36001 Boehringer Ingelheim Investigational Site
- 511.118.36005 Boehringer Ingelheim Investigational Site
- 511.118.36003 Boehringer Ingelheim Investigational Site
- 511.118.36004 Boehringer Ingelheim Investigational Site
- 511.118.39004 Boehringer Ingelheim Investigational Site
- 511.118.39001 Boehringer Ingelheim Investigational Site
- 511.118.39003 Boehringer Ingelheim Investigational Site
- 511.118.31006 Boehringer Ingelheim Investigational Site
- 511.118.31001 Boehringer Ingelheim Investigational Site
- 511.118.31004 Boehringer Ingelheim Investigational Site
- 511.118.31003 Boehringer Ingelheim Investigational Site
- 511.118.31007 Boehringer Ingelheim Investigational Site
- 511.118.31005 Boehringer Ingelheim Investigational Site
- 511.118.31002 Boehringer Ingelheim Investigational Site
- 511.118.34004 Boehringer Ingelheim Investigational Site
- 511.118.34003 Boehringer Ingelheim Investigational Site
- 511.118.34002 Boehringer Ingelheim Investigational Site
- 511.118.34001 Boehringer Ingelheim Investigational Site
- 511.118.46004 Boehringer Ingelheim Investigational Site
- 511.118.46009 Boehringer Ingelheim Investigational Site
- 511.118.46001 Boehringer Ingelheim Investigational Site
- 511.118.46006 Boehringer Ingelheim Investigational Site
- 511.118.46005 Boehringer Ingelheim Investigational Site
- 511.118.46003 Boehringer Ingelheim Investigational Site
- 511.118.44009 Boehringer Ingelheim Investigational Site
- 511.118.44004 Boehringer Ingelheim Investigational Site
- 511.118.44008 Boehringer Ingelheim Investigational Site
- 511.118.44003 Boehringer Ingelheim Investigational Site
- 511.118.44001 Boehringer Ingelheim Investigational Site
- 511.118.44002 Boehringer Ingelheim Investigational Site
- 511.118.44007 Boehringer Ingelheim Investigational Site
- 511.118.44010 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Experimental
flibanserin flexible dose
Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening. Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.