ABSTRACT
Two phase II clinical studies were performed. A total of 447 women receiving oral ERT, and varying by age, weight and time since surgical menopause, were enrolled in a 6-month, double-blind, multicenter trial. They were randomly assigned to receive placebo or testosterone 150, 300 or 450 µg/day by transdermal patch. A 6-month safety extension was added to this trial and 155 women consented to participate, continuing to receive the same dose. In the second trial, 77 women receiving transdermal ERT, and likewise diverse in baseline characteristics, were enrolled in a double-blind, 6-month multicenter trial in which they were randomized to receive placebo or a 300 µg/day transdermal testosterone patch.
