A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder

Phase 3

Terminated

• Conditions: Sexual Dysfunctions, Psychological
• Interventions: Drug: flibanserin

• Registration Number: NCT01103362
• Lead Sponsor: Sprout Pharmaceuticals, Inc

Brief Summary

To generate additional long-term safety and efficacy data on flibanserin in premenopausal women and establish long-term safety and tolerability of flibanserin in naturally postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior clinical trial of flibanserin (Trial 511.130, 511.147, or 511.156).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-14
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2014-04
• Results First Submitted: 2014-04-11
• Results First Submitted QC: 2014-04-11
• Last Update Submitted: 2014-04-11
• Results First Posted: 2014-05-12
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 596

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
flibanserin 100mg	flibanserin	flibanserin 100mg po qd

Primary Outcome Measures

Name	Time	Method
The Frequency of Adverse Events	A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD

Trial Locations

Locations (95)

511.133.01074 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

511.133.01141 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

511.133.01046 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntsville, Alabama, United States

511.133.01042 Boehringer Ingelheim Investigational Site; 🇺🇸 Mobile, Alabama, United States

511.133.01025 Boehringer Ingelheim Investigational Site; 🇺🇸 Phoenix, Arizona, United States

511.133.01073 Boehringer Ingelheim Investigational Site; 🇺🇸 Phoenix, Arizona, United States

511.133.01127 Boehringer Ingelheim Investigational Site; 🇺🇸 Tuscon, Arizona, United States

511.133.01030 Boehringer Ingelheim Investigational Site; 🇺🇸 Encinitas, California, United States

511.133.01028 Boehringer Ingelheim Investigational Site; 🇺🇸 Fair Oaks, California, United States

511.133.01037 Boehringer Ingelheim Investigational Site; 🇺🇸 Irvine, California, United States

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