Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women - Full Text View

Sponsored by:	Procter and Gamble
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00467259

Purpose

This study is designed to evaluate the endometrial safety of a testosterone patch as treatment for low libido in naturally postmenopausal women.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Randomized, Double-Blind, Placebo-controlled, Multicenter, 52-week Study to Evaluate the Endometrial Safety of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder.

Resource links provided by NLM:

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

U.S. FDA Resources

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

To estimate the incidence of endometrial hyperplasia associated with 300 mcg/day testosterone transdermal system therapy in naturally postmenopausal women with hypoactive sexual desire disorder who are not using concomitant estrogen. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment:	1271
Study Start Date:	April 2007
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (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 52 weeks
2: Experimental Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks	Drug: Testosterone Transdermal System Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks

Detailed Description:

Naturally postmenopausal women with hypoactive sexual desire disorder (HSDD) will be randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients will be stratified based on whether they use concomitant estrogen/progestin therapy and then randomized in a 4:1 ration to receive either testosterone transdermal system (300 mcg/day) or placebo. Patients using estrogen/progestin at the start of the study should maintain this therapy throughout the study; patients not using estrogen/progestin at the start of the study should not initiate estrogen/progestin therapy throughout the study. Endometrial biopsies and transvaginal ultrasounds will be collected/performed at screening and study exit for all patients. Safety will be assessed by adverse events, reports of vaginal bleeding, lipids, serum chemistry, and hematology. Physical exams, pap smears, and mammograms will be monitored.

Eligibility

Ages Eligible for Study:	45 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women will be screened for study participation and must be at least one year post menopausal, 45-70 years old, in general good health, and may or may not be on hormone therapy, and must have low sexual desire which causes distress.

Exclusion Criteria:

Women will be screened for study participation and must not be using androgen therapy or have any medical, physical, psychological, or pharmacological condition that could make participation unsafe or confound the safety evaluation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467259

Show 121 Study Locations

Sponsors and Collaborators

Procter and Gamble

Investigators

Study Director:

Johna Lucas, MD

Procter and Gamble

More Information

No publications provided

Responsible Party:	Procter and Gamble Pharmaceuticals ( Johna Lucas, MD )
Study ID Numbers:	2007004
Study First Received:	April 27, 2007
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00467259 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Procter and Gamble:

Natural Menopause

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Methyltestosterone
Dyskinesias
Hormones
Testosterone 17 beta-cypionate

Signs and Symptoms
Anabolic Agents
Testosterone
Mental Disorders
Neurologic Manifestations
Hypokinesia
Menopause
Androgens

Additional relevant MeSH terms:

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

Pharmacologic Actions
Testosterone 17 beta-cypionate
Signs and Symptoms
Anabolic Agents
Testosterone
Pathologic Processes
Mental Disorders
Therapeutic Uses
Neurologic Manifestations
Hypokinesia
Androgens

ClinicalTrials.gov processed this record on September 03, 2009