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Flibanserin Evaluation Over 28 Additional Weeks in HSDD
This study is ongoing, but not recruiting participants.
First Received: January 15, 2008   Last Updated: April 22, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00601367
  Purpose

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


Condition Intervention Phase
Sexual Dysfunctions, Psychological
Drug: BIMT 17 BS 25 mg
Drug: BIMT 17 BS 50 mg
Drug: BIMT 17 BS 100 mg
Phase III

MedlinePlus related topics: Female Sexual Dysfunction
Drug Information available for: Flibanserin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Single Group Assignment, Safety/Efficacy Study
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 Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Frequency of Adverse events

Secondary Outcome Measures:
  • FSFI desire subscale, FSDS R, PGI Improvement, CGI Improvement, Patient Benefit Evaluation

Estimated Enrollment: 457
Study Start Date: January 2008
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601367

  Show 68 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 511.118
Study First Received: January 15, 2008
Last Updated: April 22, 2009
ClinicalTrials.gov Identifier: NCT00601367     History of Changes
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna;   Belgium: Federal Agency for Medicines and Health Products;   Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10;   Finland: National Agency for Medicines;   France: AFFSAPS;   Germany: Federal Institute for Drugs and Medical Devices;   Great Britain: MHRA;   Hungary: National Institute of Pharmacy, H-1051 Budapest;   Italy: Comitato Etico Centrale - Fondazione S. Maugeri IRCCS - PAVIA;   Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO) Parnassusplein 5 2511 VX DEN HAAG;   Spain: Spanish Agency for Medicines and Health Products;   Sweden: Regional Ethics Committee of Stockholm, PO Box 289, SE-17177 Stockholm, Sweden. Medical Products Agency, PO Box 26, SE-751 03 Uppsala, Sweden;   United States: Food and Drug Administration

Study placed in the following topic categories:
Sexual Dysfunctions, Psychological
Mental Disorders

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Mental Disorders
Sexual and Gender Disorders

ClinicalTrials.gov processed this record on May 06, 2009