Home
Clinical Trials
NCT00612742

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

Last Updated: 2021-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3656 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoactive Sexual Desire Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cardiovascular event Breast Cancer Testosterone Menopause Hypoactive Sexual Desire Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

testosterone gel

1% testosterone transdermal gel

Group Type EXPERIMENTAL

testosterone gel

Intervention Type DRUG

once daily transdermal testosterone gel, 300 mcg

placebo gel

placebo transdermal gel

Group Type PLACEBO_COMPARATOR

placebo gel

Intervention Type DRUG

once daily transdermal placebo gel

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

testosterone gel

once daily transdermal testosterone gel, 300 mcg

Intervention Type DRUG

placebo gel

once daily transdermal placebo gel

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LibiGel

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Postmenopausal female subjects

* at least 50 years of age
* with at least two points of cardiovascular risk
* with a clinical diagnosis of HSDD.

Exclusion Criteria

Subjects must not

* require treatment with anti-androgens, high-dose oral or injectable corticosteroids, tamoxifen or other selective estrogen receptor modulators,
* have used androgen therapy within 2 months of randomization,
* have a history of estrogen-dependent neoplasia or any gynecologic cancer,
* have a history of cancer of any kind in the past 10 years prior to randomization,
* have a history of malignant melanoma or a history of invasive cancer at any time,
* have a screening mammogram with any finding that requires follow up within 6 months of randomization,
* have a history of myocardial infarction, coronary revascularization or stroke within 12 months of randomization,
* have any medical condition associated with predicted survival of less than 3 years in the judgment of the Investigator.

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael C Snabes, MD, PhD

Role: STUDY_DIRECTOR

BioSante Pharmaceuticals, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

BioSante Site #215

Birmingham, Alabama, United States

Site Status

BioSante Site 185

Birmingham, Alabama, United States

Site Status

BioSante Site 095

Hoover, Alabama, United States

Site Status

BioSante Site #014

Huntsville, Alabama, United States

Site Status

BioSante Site 196

Huntsville, Alabama, United States

Site Status

BioSante Site 146

Mobile, Alabama, United States

Site Status

BioSante Site 171

Chandler, Arizona, United States

Site Status

BioSante Site 145

Glendale, Arizona, United States

Site Status

BioSante Site 027

Glendale, Arizona, United States

Site Status

BioSante Site 121

Phoenix, Arizona, United States

Site Status

BioSante Site 137

Tucson, Arizona, United States

Site Status

BioSante Site 040

Tucson, Arizona, United States

Site Status

BioSante Site 052

Hot Springs, Arkansas, United States

Site Status

BioSante Site 100

Jonesboro, Arkansas, United States

Site Status

BioSante Site #060

Little Rock, Arkansas, United States

Site Status

BioSante Site 155

Little Rock, Arkansas, United States

Site Status

BioSante Site 011

Los Angeles, California, United States

Site Status

BioSante Site 094

Palm Springs, California, United States

Site Status

BioSante Site 043

Roseville, California, United States

Site Status

BioSante Site 162

Sacramento, California, United States

Site Status