MedTrace Logo

Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

NCT00996164 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1090

Last updated 2014-05-19

Study results available
· View outcomes & findings →

Summary

The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.

Conditions

  • Sexual Dysfunctions, Psychological

Interventions

DRUG

Flibanserin

patients will be randomized to flibanserin or placebo in a double-blind manner

DRUG

Placebo

patients will be randomized to flibanserin or placebo in a double-blind manner

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
2009-10-31
Primary Completion
2010-12-31
Completion
2011-02-28

Countries

  • United States

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 NCT00996164 on ClinicalTrials.gov