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

Warner Chilcott

Status and phase: Completed; Phase 3

Conditions: Hypoactive Sexual Desire Disorder

Treatments: Drug: Placebo patch; Drug: Testosterone Transdermal System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00467259

2007004

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,271 patients

Sex: Female

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,271 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

28 cm² Placebo patch

Treatment:

Drug: Placebo patch

Testosterone

Experimental group

Description:

Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks

Treatment:

Drug: Testosterone Transdermal System