Study of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido - Full Text View

Sponsored by:	Procter and Gamble
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00338312

Purpose

This study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in naturally menopausal women who are taking estrogen or estrogen/progestin therapy.

Condition	Intervention	Phase
Hypoactive Sexual Desire Disorder	Drug: Testosterone Transdermal System Drug: Placebo patch	Phase III

MedlinePlus related topics: Menopause

Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Study to Evaluate the Efficacy/Safety of Transdermal Testosterone for 52 Weeks and Safety for 52 Weeks in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder on Oral Hormone Replacement Therapy.

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

To assess the efficacy of the transdermal system (TTS) as measured by the change from baseline in the frequency of total satisfying sexual activity captured by the Sexual Activity Log (SAL). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the efficacy measured by the change from baseline in sexual desire using personal distress as measured by the Personal Distress Scale (PDS) score; the other 6 domains of the Profile of Female Sexual function, and the other 8 SAL endpoints. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	610
Study Start Date:	June 2002
Study Completion Date:	July 2006
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo patch	Drug: Placebo patch placebo patch changed twice a week for one year
2: Experimental testosterone patch (300 mcg/day) patch changed 2 times/week, for one year	Drug: Testosterone Transdermal System testosterone patch (300 mcg/day) patch changed 2 times/week, for one year

Detailed Description:

Naturally menopausal women with hypoactive sexual desire disorder (HSDD) were randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients were stratified based on presence/absence of uterus and randomized to receive placebo or testosterone transdermal system. Patients had to maintain a stable dose of estrogen/progestin throughout the study. Patients who completed the first 52 weeks of the study were given the opportunity to participate in year 2-4 open-label (active treatment) study extension which was added to the protocol by amendment. Safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabois in evaluation, coagulation testing, and hermatology. Physical exam including clinical assessments of facial hair and acne were monitored.

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Eligible women must:

Be 40-70 years old and in generally good health
Be post-menopausal with no spontaneous periods for 1 year
Be receiving a stable dose of hormone replacement therapy for at least 3 months prior to screening with the intention of maintaining that regimen.
Be, in her own judgment, in a stable, monogamous sexual relationship that is perceived to be secure and communicative, for at least one year prior to study entry
Meet the criteria for having hypoactive sexual desire disorder

Exclusion Criteria:

Eligible women must not:

Have received androgen therapy at any time during the past 3 months (during the past 7 months if therapy was an investigational implantable product)
Be experiencing any chronic or acute life stress relating to any major life change
Be experiencing depression and/or receiving medication for such illness or disorder
Have current severe skin problems (such as severe or cystic acne) or allergy to adhesives (like the ones in bandages)
Have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months
Have a history of breast, endometrial, or other gynecological cancer at any time before study participation or other cancer within the last 5 years
Have diabetes, a history of cerebrovascular disease, thromboembolic disorders, heart attack, or angina at any time before study participation or thrombophlebitis within the last 5 years
Have abnormal laboratory test results upon initial screening for this study
Have previously participated in a clinical trial within 30 days or received an investigational medication within 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338312

Locations

United States, Colorado
Research Facility
Denver, Colorado, United States

Sponsors and Collaborators

Procter and Gamble

Investigators

Study Director:

Johna Lucas, MD

Procter and Gamble

More Information

Responsible Party:	Procter and Gamble ( Johna Lucas, MD )
Study ID Numbers:	2002005 and Yr 2-4 OL
Study First Received:	June 15, 2006
Last Updated:	February 5, 2008
ClinicalTrials.gov Identifier:	NCT00338312
Health Authority:	United States: Food and Drug Administration

Keywords provided by Procter and Gamble:

Natural Menopause
HSDD

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Signs and Symptoms
Testosterone
Mental Disorders
Neurologic Manifestations

Methyltestosterone
Hypokinesia
Dyskinesias
Menopause
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Disease
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Sexual and Gender Disorders

Hormones
Pharmacologic Actions
Anabolic Agents
Pathologic Processes
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on January 16, 2009