Trial Information

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.

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.