Flibanserin Randomized Withdrawal Trial in Pre-Menopausal Women - Tabular View

Tracking Information

First Received Date ^ICMJE

January 16, 2006

Last Updated Date

December 16, 2008

Start Date ^ICMJE

January 2006

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Co-primary endpoints are the changes from randomization baseline to the final visit for satisfying sexual events per month and the desire score monthly total.

Change History

Complete list of historical versions of study NCT00277914 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Time to the loss of response, rates of loss of response, and total scores of the FSDS-R during the double-blind period.

Descriptive Information

Brief Title ^ICMJE

Flibanserin Randomized Withdrawal Trial in Pre-Menopausal Women

Official Title ^ICMJE

12-Month Sustained Efficacy of Flibanserin v Placebo n Younger Women With HSDD in NA

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Sexual Dysfunctions, Psychological

Intervention ^ICMJE

Drug: Flibanserin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

749

Completion Date

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Women over 18 and pre-menopausal
FSDS-R above 14
Willingness to try to have sexual activity at least monthly
Willingness to use an electronic diary daily
Stable, monogamous, heterosexual relationship for at least one year
Medically acceptable method of contraception

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

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00277914

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study ID Numbers ^ICMJE

511.74

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP