Flibanserin Randomized Withdrawal Trial in Pre-Menopausal Women

This study has been completed.

First Received on January 16, 2006. Last Updated on December 16, 2008 History of Changes

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00277914

Purpose

To estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment.

Condition	Intervention	Phase
Sexual Dysfunctions, Psychological	Drug: Flibanserin	Phase III

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	12-Month Sustained Efficacy of Flibanserin v Placebo n Younger Women With HSDD in NA

Resource links provided by NLM:

MedlinePlus related topics: Sexual Problems in Women

Drug Information available for: Flibanserin

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Enrollment:	749
Study Start Date:	January 2006
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Clinically relevant conditions which might interfere with the patient's abil ity to participate in the trial
Specified medications
Sexual function affected by medication
Drug dependence or abuse
Sexual partner needing treatment
Peri-Menopause or Menopause (surgical or otherwise)
Pregnancy
Pelvic Inflammatory Disease
Major depressive Episode
Significant ECG abnormalities
Significant Neurologic findings
Significant GI, Hepatic, Cardiovascular, Renal, Hematologic, Immunologic or Respiratory findings
Uncorrected thyroid or endocrine disease
Uncontrolled Glaucoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277914

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00277914 History of Changes
Other Study ID Numbers:	511.74
Study First Received:	January 16, 2006
Last Updated:	December 16, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012