MedTrace Logo

Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America

NCT01057901 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 748

Last updated 2014-06-17

Study results available
· View outcomes & findings →

Summary

The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.

Conditions

  • Sexual Dysfunctions, Psychological

Interventions

DRUG

Flibanserin

Flibanserin 100mg administered at bedtime for 24 weeks

DRUG

Placebo

This is the matched placebo which will be administered two tablets daily at bedtime.

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
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

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 NCT01057901 on ClinicalTrials.gov