Women Call Improved Libido With Testosterone Patch a Meaningful Benefit

CLEVELAND, Aug. 15 -- For women with hypoactive sexual desire disorder following surgical menopause, low doses of testosterone delivered by an investigational transdermal patch improved desire and function, reported researchers here.
Fifty-two percent of women who received 300 mcg per day of testosterone transdermally said they had experienced a "meaningful treatment benefit" versus 31% of women in the placebo group (P=0.025), wrote Sheryl Kingsberg, Ph.D., of University Hospitals, and colleagues, in the August issue of the Journal of Sexual Medicine.
Overall, women randomized to testosterone reported an increase in frequency of sexual activity compared with women in the placebo arm -- an increase in sexual activity of 4.4 times per four weeks versus 0.5 times per four weeks for women in the placebo group (P<0.001).
Other studies have reported statistically significant improvement in prespecified markers such as sexual activity associated with testosterone therapy (See Testosterone May Patch Up Desire After Surgical Menopause), but the authors said this was the first study to assess whether those improvements were meaningful.
Dr. Kingsberg and colleagues analyzed data-structured interviews with a representative sample of 132 surgically postmenopausal women who were enrolled in two randomized, placebo-controlled trials of transdermal testosterone. All 132 women had hypoactive sexual desire disorder following the removal of uteri and ovaries.
The women were randomized to transdermal testosterone or placebo for six months. At the end of the study, but before unblinding, frequency of satisfying sexual activity, increase in sexual desire, and decrease in personal distress were assessed by structured interview. In addition, 132 women were asked "Overall, would you say that you experienced a meaningful benefit from the study patches?"
Women in the sample were in their late forties and most were about nine years post hysterectomy-oophorectomy. About 90% of the women were white and most had been in an intimate relationship for more than 18 years.
Overall, women randomized to testosterone reported an increase in frequency of sexual activity compared with women in the placebo arm -- 4.4 times per four weeks versus an increase in sexual activity of 0.5 times per four weeks for women in the placebo group (P<0.001).
Women in the testosterone arm were also more likely to report that the treatment "met their expectations" than women in the placebo group, 47% versus 27% (P=0.030), they wrote.
Not surprisingly women who said the treatment was beneficial were also more likely to be willing to continue treatment -- 85% versus 10%.
The authors said, however, that there was a potential for selection bias in the study because while the sample was representative of the study population, "the sample was not randomly selected."
Moreover, they because that interviews were only conducted at study sites within the United States, but since more than 90% of the participants in the two randomized trials were enrolled at U.S. centers, "this geographic limitation would not be expected to have any substantial effect on the results."
The study was funded by Procter & Gamble Pharmaceuticals, Inc., of Cincinnati. The authors reported no financial disclosures.Primary source: Journal of Sexual MedicineSource reference: Kingsberg S et al "Evaluation of the Clinical Relevance of Benefits Associated with Transdermal Testosterone Treatment in Postmenopausal Women with Hypoactive Sexual Disease Disorder" J Sex Med 2007; 4:1001-1008.