Testosterone Patch for Low Sexual Desire in Surgically... : Obstetrics & Gynecology (original) (raw)

Original Research

Testosterone Patch for Low Sexual Desire in Surgically Menopausal Women: A Randomized Trial

Buster, John E. MD*; Kingsberg, Sheryl A. PhD‡; Aguirre, Oscar MD§; Brown, Candace PhD¶; Breaux, Jeffrey G. MD**; Buch, Akshay PhD†; Rodenberg, Cynthia A. PhD†; Wekselman, Kathryn RN, PhD†; Casson, Peter MD∥

From the *Baylor College of Medicine, Houston, Texas;† Case Western Reserve University School of Medicine, University Hospitals of Cleveland, Cleveland, Ohio;§ Colorado Gynecology & Continence Center, Denver, Colorado; ¶University of Tennessee College of Pharmacy, Memphis, Tennessee; **Baton Rouge, Louisiana; Procter & Gamble Pharmaceuticals, Inc., Cincinnati, Ohio;‡ ∥and University of Vermont College of Medicine, Burlington, Vermont.

Financial Disclosure: Procter & Gamble Pharmaceuticals, Inc. (Cincinnati, OH) provided financial support for this study, statistical analysis of study results, and assistance in preparation of the manuscript.

Drs. Buch, Rodenberg, and Wekselman are employees of Procter & Gamble Pharmaceuticals, Inc.

Reprints are not available. Address correspondence requests to: John E. Buster, MD, Department of Obstetrics and Gynecology, Baylor College of Medicine, 6550 Fannin, Suite 900, Houston, TX 77030; e-mail: [email protected].

Received September 1, 2004. Received in revised form January 14, 2005. Accepted January 19, 2005.

OBJECTIVE:

To assess the efficacy and safety of a 300 μg/d testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women on concomitant estrogen therapy.

METHODS:

Five hundred thirty-three women with hypoactive sexual desire disorder who had undergone previous hysterectomy and bilateral oophorectomy were enrolled in a 24-week, multicenter, double-blind, placebo-controlled trial. Patients were randomly assigned to receive placebo or the testosterone patch twice weekly. The primary efficacy endpoint was change from baseline at week 24 in the frequency of total satisfying sexual activity, measured by the Sexual Activity Log. Secondary measures included sexual desire using the Profile of Female Sexual Function and personal distress as measured by the Personal Distress Scale. Hormone levels, adverse events, and clinical laboratory measures were reviewed.

RESULTS:

Total satisfying sexual activity significantly improved in the testosterone patch group compared with placebo after 24 weeks (mean change from baseline, 1.56 compared with 0.73 episodes per 4 weeks, P = .001). Treatment with the testosterone patch also significantly improved sexual desire (mean change, 10.57 compared with 4.29, P < .001) and decreased personal distress (_P_ = .009). Serum free, total, and bioavailable testosterone concentrations increased from baseline. Overall, adverse events were similar in both groups (_P_ > .05). The incidence of androgenic adverse events was higher in the testosterone group; most androgenic adverse events were mild.

CONCLUSION: