Safety and efficacy of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women: a randomized, placebo-controlled trial.
BACKGROUND
Oophorectomy reduces serum testosterone levels. We studied the efficacy and safety of transdermal testosterone in treating hypoactive sexual desire disorder in surgically menopausal women.


METHODS
A 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial was conducted in women (aged 24-70 years) who developed distressful low sexual desire after bilateral salpingo-oophorectomy and hysterectomy and who were receiving oral estrogen therapy. Women were randomized to receive placebo (n = 119) or testosterone patches in dosages of 150 microg/d (n = 107), 300 microg/d (n = 110), or 450 microg/d (n = 111) twice weekly for 24 weeks. Sexual desire and frequency of satisfying sexual activity were primary efficacy outcome measures.


RESULTS
Of the 447 women randomized, 318 (71%) completed the trial. Compared with placebo, women receiving the 300-microg/d testosterone patch had significantly greater increases from baseline in sexual desire (67% vs 48%; P = .05) and in frequency of satisfying sexual activity (79% vs 43%; P = .049). The 150-microg/d group showed no evidence of a treatment effect. The 450-microg/d group also was not statistically different from the 300-microg/d or placebo groups. Marginally significant linear dose-response trends were observed for total satisfying sexual activity and sexual desire at 24 weeks (P = .06 and .06, respectively). Adverse events occurred with similar frequency in both groups; no serious safety concerns were observed.


CONCLUSIONS
The 300-microg/d testosterone patch increased sexual desire and frequency of satisfying sexual activity and was well tolerated in women who developed hypoactive sexual desire disorder after surgical menopause.
Braunstein
Glenn D
GD
Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, Calif, 90048, USA. Glenn.Braunstein@cshs.org
Sundwall
Dale A
DA
Katz
Molly
M
Shifren
Jan L
JL
Buster
John E
JE
Simon
James A
JA
Bachman
Gloria
G
Aguirre
Oscar A
OA
Lucas
Johna D
JD
Rodenberg
Cynthia
C
Buch
Akshay
A
Watts
Nelson B
NB
D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000728:Androgens / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004967:Estrogens / Q000627:therapeutic use; D005260:Female; D012739:Gonadal Steroid Hormones / Q000097:blood; D006801:Humans; D007044:Hysterectomy; D008594:Menopause, Premature / Q000187:drug effects; D008875:Middle Aged; D010052:Ovariectomy / Q000009:adverse effects*; D012725:Sexual Behavior / Q000187:drug effects*; D020018:Sexual Dysfunctions, Psychological / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D013739:Testosterone / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000728:Androgens; D004967:Estrogens; D012739:Gonadal Steroid Hormones; D013739:Testosterone