OBJECTIVE: To evaluate the efficacy and safety of a testosterone patch for the treatment of women with hypoactive sexual desire disorder after natural menopause. DESIGN: A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was conducted in naturally menopausal women with hypoactive sexual desire disorder receiving a stable dose of oral estrogen with or without progestin (N = 549). Women were randomized to receive testosterone 300 microg/day or placebo patches twice weekly for 24 weeks. The primary efficacy measure was change from baseline in frequency of total satisfying sexual activity over a 4-week period (weeks 21-24). RESULTS: A total of 483 women (88%) were included in the primary analysis population (those with baseline sex hormone binding globulin levels < or = 160 nmol/L). The change from baseline in number of total satisfying sexual episodes was significantly greater for testosterone compared with placebo (participants with baseline sex hormone binding globulin levels < or = 160 nmol/L, mean change of 2.1 +/- 0.28 versus 0.5 +/- 0.23 episodes/4 weeks; P < 0.0001; intent-to-treat population, mean change from baseline of 1.9 +/- 0.26 versus 0.5 +/- 0.21 episodes/4 weeks, P < 0.0001). Testosterone also produced statistically significant improvements compared with placebo in all secondary efficacy measures, including sexual desire and personal distress. The testosterone patch was well tolerated. CONCLUSIONS:Testosterone patch treatment increased the frequency of satisfying sexual activity and sexual desire, decreased personal distress, and was well tolerated in naturally menopausal women with hypoactive sexual desire disorder.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of a testosterone patch for the treatment of women with hypoactive sexual desire disorder after natural menopause. DESIGN: A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was conducted in naturally menopausal women with hypoactive sexual desire disorder receiving a stable dose of oral estrogen with or without progestin (N = 549). Women were randomized to receive testosterone 300 microg/day or placebo patches twice weekly for 24 weeks. The primary efficacy measure was change from baseline in frequency of total satisfying sexual activity over a 4-week period (weeks 21-24). RESULTS: A total of 483 women (88%) were included in the primary analysis population (those with baseline sex hormone binding globulin levels < or = 160 nmol/L). The change from baseline in number of total satisfying sexual episodes was significantly greater for testosterone compared with placebo (participants with baseline sex hormone binding globulin levels < or = 160 nmol/L, mean change of 2.1 +/- 0.28 versus 0.5 +/- 0.23 episodes/4 weeks; P < 0.0001; intent-to-treat population, mean change from baseline of 1.9 +/- 0.26 versus 0.5 +/- 0.21 episodes/4 weeks, P < 0.0001). Testosterone also produced statistically significant improvements compared with placebo in all secondary efficacy measures, including sexual desire and personal distress. The testosterone patch was well tolerated. CONCLUSIONS:Testosterone patch treatment increased the frequency of satisfying sexual activity and sexual desire, decreased personal distress, and was well tolerated in naturally menopausal women with hypoactive sexual desire disorder.
Authors: Eliana L Sánchez Montoya; Lizaida Hernández; Jennifer L Barreto-Estrada; José G Ortiz; Juan Carlos Jorge Journal: J Sex Med Date: 2010-11 Impact factor: 3.802
Authors: Rakibul M Islam; Robin J Bell; David J Handelsman; Penelope J Robinson; Rory Wolfe; Susan R Davis Journal: Clin Endocrinol (Oxf) Date: 2021-01-02 Impact factor: 3.478
Authors: Amanda Jones; Dong Jin Hwang; Charles B Duke; Yali He; Anjaiah Siddam; Duane D Miller; James T Dalton Journal: J Pharmacol Exp Ther Date: 2010-05-05 Impact factor: 4.030
Authors: Grace Huang; Shehzad Basaria; Thomas G Travison; Matthew H Ho; Maithili Davda; Norman A Mazer; Renee Miciek; Philip E Knapp; Anqi Zhang; Lauren Collins; Monica Ursino; Erica Appleman; Connie Dzekov; Helene Stroh; Miranda Ouellette; Tyler Rundell; Merilyn Baby; Narender N Bhatia; Omid Khorram; Theodore Friedman; Thomas W Storer; Shalender Bhasin Journal: Menopause Date: 2014-06 Impact factor: 2.953