Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00601367
First received: January 15, 2008
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens


Condition Intervention Phase
Sexual Dysfunctions, Psychological
Drug: flibanserin flexible dose
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Twenty-Eight Week, Open-Label, Safety Study of Flibanserin 50 Mgs to 100 Mgs Daily in Premenopausal European Women With HSDD

Further study details as provided by Sprout Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Frequency of Adverse Events [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 480
Study Start Date: January 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: 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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601367

  Show 68 Study Locations
Sponsors and Collaborators
Sprout Pharmaceuticals, Inc
Investigators
Study Chair: Sprout Pharmaceuticals Sprout Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00601367     History of Changes
Other Study ID Numbers: 511.118
Study First Received: January 15, 2008
Results First Received: April 22, 2014
Last Updated: May 20, 2014
Health Authority: Austria: Austrian Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Flibanserin
Serotonin 5-HT1 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin 5-HT2 Receptor Antagonists

ClinicalTrials.gov processed this record on September 22, 2014