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Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

NCT00360555 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1584

Last updated 2016-06-27

Study results available
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Summary

This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard diagnostic criteria.

Efficacy for flibanserin will be assessed vs. a parallel placebo group.

Conditions

  • Sexual Dysfunctions, Psychological

Interventions

DRUG

flibanserin

flibanserin 25 mg b.i.d

DRUG

flibanserin 50mg

flibanserin 50mg qhs/b.i.d.

DRUG

flibanserin 100mg

flibanserin 50 mg b.i.d/100mg qhs

DRUG

placebo

placebo comparator

Sponsors & Collaborators

  • Sprout Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT00360555 on ClinicalTrials.gov