Testosterone for low libido in postmenopausal women not taking estrogen.
BACKGROUND
The efficacy and safety of testosterone treatment for hypoactive sexual desire disorder in postmenopausal women not receiving estrogen therapy are unknown.


METHODS
We conducted a double-blind, placebo-controlled, 52-week trial in which 814 women with hypoactive sexual desire disorder were randomly assigned to receive a patch delivering 150 or 300 microg of testosterone per day or placebo. Efficacy was measured to week 24; safety was evaluated over a period of 52 weeks, with a subgroup of participants followed for an additional year. The primary end point was the change from baseline to week 24 in the 4-week frequency of satisfying sexual episodes.


RESULTS
At 24 weeks, the increase in the 4-week frequency of satisfying sexual episodes was significantly greater in the group receiving 300 microg of testosterone per day than in the placebo group (an increase of 2.1 episodes vs. 0.7, P<0.001) but not in the group receiving 150 microg per day (1.2 episodes, P=0.11). As compared with placebo, both doses of testosterone were associated with significant increases in desire (300 microg per day, P<0.001; 150 microg per day, P=0.04) and decreases in distress (300 microg per day, P<0.001; 150 microg per day, P=0.04). The rate of androgenic adverse events - primarily unwanted hair growth - was higher in the group receiving 300 microg of testosterone per day than in the placebo group (30.0% vs. 23.1%). Breast cancer was diagnosed in four women who received testosterone (as compared with none who received placebo); one of the four received the diagnosis in the first 4 months of the study period, and one, in retrospect, had symptoms before undergoing randomization.


CONCLUSIONS
In postmenopausal women not receiving estrogen therapy, treatment with a patch delivering 300 microg of testosterone per day resulted in a modest but meaningful improvement in sexual function. The long-term effects of testosterone, including effects on the breast, remain uncertain. (ClinicalTrials.gov number, NCT00131495.)
Davis
Susan R
SR
Women's Health Program, Monash University, Alfred Hospital, Prahran, Australia. susan.davis@med.monash.edu.au
Moreau
Michele
M
Kroll
Robin
R
Bouchard
Céline
C
Panay
Nick
N
Gass
Margery
M
Braunstein
Glenn D
GD
Hirschberg
Angelica Linden
AL
Rodenberg
Cynthia
C
Pack
Simon
S
Koch
Helga
H
Moufarege
Alain
A
Studd
John
J
D000279:Administration, Cutaneous; D000728:Androgens / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000453:epidemiology; D004311:Double-Blind Method; D005260:Female; D006628:Hirsutism / Q000139:chemically induced; D006728:Hormones / Q000097:blood; D006801:Humans; D007989:Libido / Q000187:drug effects*; D008875:Middle Aged; D009948:Orgasm / Q000187:drug effects; D017698:Postmenopause / Q000187:drug effects / Q000502:physiology; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy*; D013739:Testosterone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000728:Androgens; D006728:Hormones; D013739:Testosterone