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Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)

NCT01235754 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 626

Last updated 2013-01-10

No results posted yet for this study

Summary

The objective of this study is to evaluate the persistence of benefit of LibiGel (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.

Conditions

  • Hypoactive Sexual Desire Disorder

Interventions

DRUG

transdermal testosterone gel 1%

300 mcg once daily transdermal testosterone gel 1%

DRUG

placebo gel

once daily transdermal placebo gel

Sponsors & Collaborators

  • BioSante Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Michael C Snabes, MD, PhD · BioSante Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
66 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-12-31
Completion
2012-01-31

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 NCT01235754 on ClinicalTrials.gov