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Flibanserin Versus Placebo in Premenopausal Women With HSDD

NCT00491829 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 945

Last updated 2014-06-02

Study results available
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Summary

To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women.

To evaluate safety and tolerability of flibanserin in such patients.

Conditions

  • Sexual Dysfunctions, Psychological

Interventions

DRUG

50 mg qhs

flibanserin 50 mg

DRUG

100 mg

flibanserin 100mg

DRUG

placebo

placebo

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
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Austria
  • Belgium
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Norway
  • Spain
  • Sweden
  • United Kingdom

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 NCT00491829 on ClinicalTrials.gov