Testosterone patch increases sexual activity and desire in surgically menopausal women with hypoactive sexual desire disorder.
BACKGROUND
Hypoactive sexual desire disorder (HSDD) is one of the most common sexual problems reported by women, but few studies have been conducted to evaluate treatments for this condition.


OBJECTIVE
The objective of this study was to evaluate the efficacy and safety of a testosterone patch in surgically menopausal women with HSDD.


METHODS
The design was a randomized, double-blind, parallel-group, placebo-controlled, 24-wk study (the Intimate SM 1 study).


METHODS
The study was performed at private or institutional practices.


METHODS
The subjects studied were women, aged 26-70 yr, with HSDD after bilateral salpingo-oophorectomy who were receiving concomitant estrogen therapy. Placebo (n = 279) or testosterone 300 microg/d (n = 283) was administered. There were 19 patients who withdrew due to adverse events in the placebo group and 24 in the 300 mug/d testosterone group.


METHODS
Testosterone (300 microg/d) or placebo patches were applied twice weekly.


METHODS
The primary end point was the change in the frequency of total satisfying sexual activity at 24 wk. Secondary end points included other sexual functioning end points and safety assessments.


RESULTS
At 24 wk, there was an increase from baseline in the frequency of total satisfying sexual activity of 2.10 episodes/4 wk in the testosterone group, which was significantly greater than the change of 0.98 episodes/4 wk in the placebo group (P = 0.0003). The testosterone group also experienced statistically significant improvements in sexual desire and a decrease in distress. The overall safety profile was similar in both treatment groups.


CONCLUSIONS
In the Intimate SM 1 study, the testosterone patch improved sexual function and decreased distress in surgically menopausal women with HSDD and was well tolerated in this trial.
Simon
James
J
Women's Health Research Center (J.S.), Laurel, Maryland 20707, USA. jasimon@whrc.net
Braunstein
Glenn
G
Nachtigall
Lila
L
Utian
Wulf
W
Katz
Molly
M
Miller
Sam
S
Waldbaum
Arthur
A
Bouchard
Celine
C
Derzko
Christine
C
Buch
Akshay
A
Rodenberg
Cynthia
C
Lucas
Johna
J
Davis
Susan
S
D000279:Administration, Cutaneous; D000728:Androgens / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects; D006801:Humans; D007989:Libido / Q000187:drug effects*; D008594:Menopause, Premature; D012725:Sexual Behavior / Q000187:drug effects*; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy* / Q000503:physiopathology*; D013739:Testosterone / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use; D016896:Treatment Outcome
D000728:Androgens; D013739:Testosterone