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Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

NCT00612742 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3656

Last updated 2021-10-29

No results posted yet for this study

Summary

This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

Conditions

  • Hypoactive Sexual Desire Disorder

Interventions

DRUG

testosterone gel

once daily transdermal testosterone gel, 300 mcg

DRUG

placebo gel

once daily transdermal placebo gel

Sponsors & Collaborators

  • BioSante Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Michael C Snabes, MD, PhD · BioSante Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2012-10-31
Completion
2012-12-31

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 NCT00612742 on ClinicalTrials.gov