Evaluation of the clinical relevance of benefits associated with transdermal testosterone treatment in postmenopausal women with hypoactive sexual desire disorder.
BACKGROUND
Postmenopausal women with hypoactive sexual desire disorder (HSDD) experienced statistically significant improvements in the frequency of satisfying sexual activity, sexual desire, and distress with testosterone treatment in phase III trials, but it was not known whether the magnitude of these effects was clinically meaningful. The clinical relevance study was designed to answer this question.


OBJECTIVE
To evaluate the clinical relevance of the treatment benefits.


METHODS
This study involved a representative sample of 132 surgically postmenopausal women with HSDD who were enrolled in two randomized, placebo-controlled trials (N = 1094) assessing the efficacy and safety of transdermal testosterone treatment (300 mcg/day) for 6 months. At the end of the studies, prior to unblinding, a sample of women (12%) was interviewed concerning their experiences with the treatment.


METHODS
Women were asked "Overall, would you say that you experienced a meaningful benefit from the study patches?" Changes in the efficacy end points in the double-blind studies were compared for the women who did and did not experience an overall meaningful benefit.


RESULTS
Overall, 33 of 64 women (52%) who received testosterone reported experiencing a meaningful treatment benefit, compared with 21 of 68 women (31%) who received placebo (P = 0.025). Among the women who identified themselves as experiencing a meaningful benefit, the mean (SE) change from baseline in 4-week frequency of satisfying sexual activity was 4.4 (0.76), in desire score was 21.0 (2.78), moving from "seldom" to "sometimes" feeling sexual desire, and in distress score was -36.5 (3.96), moving from "often" to "seldom" being distressed. Among the women who identified themselves as not experiencing a meaningful benefit, the mean (SE) change from baseline in 4-week frequency of satisfying sexual activity was 0.5 (0.31), in desire score was 2.9 (1.42), and in distress score was -8.8 (2.23).


CONCLUSIONS
Surgically menopausal women with HSDD in these studies received clinically meaningful benefits, including improvements in satisfying sexual activity, sexual desire, and personal distress.
Kingsberg
Sheryl
S
University Hospitals of Cleveland, 11100 Euclid Avenue, Cleveland, OH 44106, USA. Sheryl.Kingsberg@UHhospitals.org
Shifren
Jan
J
Wekselman
Kathryn
K
Rodenberg
Cynthia
C
Koochaki
Patricia
P
Derogatis
Leonard
L
D000279:Administration, Cutaneous; D000328:Adult; D000728:Androgens / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006304:Health Status; D006801:Humans; D007989:Libido / Q000187:drug effects; D008594:Menopause, Premature; D008875:Middle Aged; D012725:Sexual Behavior / Q000187:drug effects; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy*; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy*; D013739:Testosterone / Q000008:administration & dosage*; D016896:Treatment Outcome; D016387:Women's Health
D000728:Androgens; D013739:Testosterone