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Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women

NCT00613002 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 597

Last updated 2013-01-10

No results posted yet for this study

Summary

This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel® 300mcg in the treatment of HSDD in surgically menopausal women

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
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2011-09-30
Completion
2011-09-30

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 NCT00613002 on ClinicalTrials.gov