Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America

Phase 3

Terminated

• Conditions: Sexual Dysfunctions, Psychological
• Interventions: Drug: Placebo; Drug: Flibanserin

• Registration Number: NCT01057901
• Lead Sponsor: Sprout Pharmaceuticals, Inc

Brief Summary

The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2014-04-14
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-16
• Last Update Submitted: 2014-06-16
• Results First Posted: 2014-06-17
• Last Update Posted: 2014-06-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 748

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	This is the matched placebo which will be administered two tablets daily at bedtime.
Flibanserin 100 mg	Flibanserin	Flibanserin 100 mg administered at bedtime

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Number of Satisfying Sexual Events	baseline to 24 weeks	The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered).; "Satisfying" means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.
Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain	baseline to 24 weeks	The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (1 is lowest level of desire and 5 is the highest level of desire). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.

Trial Locations

Locations (100)

511.156.01059 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

511.156.01084 Boehringer Ingelheim Investigational Site; 🇺🇸 Tucson, Arizona, United States

511.156.01053 Boehringer Ingelheim Investigational Site; 🇺🇸 Tuscon, Arizona, United States

511.156.01069 Boehringer Ingelheim Investigational Site; 🇺🇸 Tuscon, Arizona, United States

511.156.01063 Boehringer Ingelheim Investigational Site; 🇺🇸 Little Rock, Arkansas, United States

511.156.01076 Boehringer Ingelheim Investigational Site; 🇺🇸 Little Rock, Arkansas, United States

511.156.01039 Boehringer Ingelheim Investigational Site; 🇺🇸 Anaheim, California, United States

511.156.01070 Boehringer Ingelheim Investigational Site; 🇺🇸 Berkeley, California, United States

511.156.01075 Boehringer Ingelheim Investigational Site; 🇺🇸 La Mesa, California, United States

511.156.01087 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

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