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

NCT01103362 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 596

Last updated 2014-05-12

Study results available
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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).

Conditions

  • Sexual Dysfunctions, Psychological

Interventions

DRUG

flibanserin

all patients will receive open-label flibanserin 100mg

Sponsors & Collaborators

  • Sprout Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Sprout Pharmaceuticals · Sprout Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01103362 on ClinicalTrials.gov