Testosterone patch for the treatment of hypoactive sexual desire disorder in naturally menopausal women: results from the INTIMATE NM1 Study.
OBJECTIVE
To evaluate the efficacy and safety of a testosterone patch for the treatment of women with hypoactive sexual desire disorder after natural menopause.


METHODS
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.
Shifren
Jan L
JL
Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, MA 02114, USA. jshifren@partners.org
Davis
Susan R
SR
Moreau
Michele
M
Waldbaum
Arthur
A
Bouchard
Celine
C
DeRogatis
Leonard
L
Derzko
Christine
C
Bearnson
Patricia
P
Kakos
Norman
N
O'Neill
Sheila
S
Levine
Stephen
S
Wekselman
Kathryn
K
Buch
Akshay
A
Rodenberg
Cynthia
C
Kroll
Robin
R
D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000728:Androgens / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008593:Menopause / Q000502:physiology; D008875:Middle Aged; D012725:Sexual Behavior / Q000187:drug effects; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy*; D013739:Testosterone / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D016896:Treatment Outcome
D000728:Androgens; D013739:Testosterone