A randomized, double-blind, placebo-controlled, parallel-group, multicentre 52-week study to evaluate the efficacy and safety of transdermal patches delivering 150 or 300 µg/day testosterone in menopausal women with low libido not receiving systemic oestrogen or oestrogen progestin therapy.
This was a double blind placebo-controlled study of two doses of testosterone administered by a transdermal (skin) patch against a placebo, for healthy post-menopausal women with loss of libido who were not using any form of HRT. The aim of this study was to evaluate the effectiveness and safety of 2 different doses of the transdermal testosterone patch in post-menopausal women with low libido who were not receiving HRT.
Participants were randomly assigned to a patch releasing either 300 micrograms or 150 micrograms of testosterone or to a placebo. The patches were applied twice weekly for 12 months. Women were assessed by well established sexual questionnaires comparing pre-treatment scores against post-treatment scores at 3 and 6 months. Subjects were monitored to ensure the safety of giving testosterone without the traditional use of concommitant HRT.