This Article Full Text Full Text (PDF) All Versions of this Article: 90/9/5226    most recent Author Manuscript (PDF) Submit a related Letter to the Editor Purchase Article View Shopping Cart Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Copyright Permission Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Simon, J. Articles by Davis, S. Search for Related Content PubMed PubMed Citation Articles by Simon, J. Articles by Davis, S. Related Collections Female Endocrinology

Testosterone Patch Increases Sexual Activity and Desire in Surgically Menopausal Women with Hypoactive Sexual Desire Disorder

Women’s Health Research Center (J.S.), Laurel, Maryland 20707; Cedars-Sinai Medical Center (G.B.), Los Angeles, California 90048; New York University School of Medicine (L.N.), New York, New York 10016; Rapid Medical Research (W.U.), Cleveland, Ohio 44122; Katz, Kade, and Hewitt, Inc. (M.K.), Cincinnati, Ohio 45219; S. A. M. Clinical Research Center (S.M.), San Antonio, Texas 78229; Downtown Women’s Health Care (A.W.), Denver, Colorado 80202; Clinique RSF, Inc. (C.B.), Quebec, Canada G1S 2L6; St. Michael’s Hospital Health Center (C.D.), Toronto, Canada M5B 1W8; Procter & Gamble Pharmaceuticals Health Care Research Center (A.B., C.R., J.L.), Mason, Ohio 45040; The Jean Hailes Foundation, Research Unit (S.D.), Clayton, Australia VIC 3168; and Department of Medicine (S.D.), Monash University, Praham, Victoria, Australia VIC 3800

Address all correspondence and requests for reprints to: Dr. James Simon, 14201 Laurel Park Drive Suite 104, Laurel, Maryland 20707. E-mail: jasimon{at}whrc.net.

Context: Hypoactive sexual desire disorder (HSDD) is one of the most common sexual problems reported by women, but few studies have been conducted to evaluate treatments for this condition.

Objective: The objective of this study was to evaluate the efficacy and safety of a testosterone patch in surgically menopausal women with HSDD.

Design: The design was a randomized, double-blind, parallel-group, placebo-controlled, 24-wk study (the Intimate SM 1 study).

Setting: The study was performed at private or institutional practices.

Patients: The subjects studied were women, aged 26–70 yr, with HSDD after bilateral salpingo-oophorectomy who were receiving concomitant estrogen therapy. Placebo (n = 279) or testosterone 300 µg/d (n = 283) was administered. There were 19 patients who withdrew due to adverse events in the placebo group and 24 in the 300 µg/d testosterone group.

Intervention: Testosterone (300 µg/d) or placebo patches were applied twice weekly.

Main Outcome Measure(s): The primary end point was the change in the frequency of total satisfying sexual activity at 24 wk. Secondary end points included other sexual functioning end points and safety assessments.

Results: At 24 wk, there was an increase from baseline in the frequency of total satisfying sexual activity of 2.10 episodes/4 wk in the testosterone group, which was significantly greater than the change of 0.98 episodes/4 wk in the placebo group (P = 0.0003). The testosterone group also experienced statistically significant improvements in sexual desire and a decrease in distress. The overall safety profile was similar in both treatment groups.

Conclusion: In the Intimate SM 1 study, the testosterone patch improved sexual function and decreased distress in surgically menopausal women with HSDD and was well tolerated in this trial.

This article has been cited by other articles:

				S. R. Davis, M. Moreau, R. Kroll, C. Bouchard, N. Panay, M. Gass, G. D. Braunstein, A. L. Hirschberg, C. Rodenberg, S. Pack, et al. Testosterone for Low Libido in Postmenopausal Women Not Taking Estrogen N. Engl. J. Med., November 6, 2008; 359(19): 2005 - 2017. [Abstract] [Full Text] [PDF]

				Writing Group for the British Menopause Society Co, J. Pitkin, M. C P Rees, S. Gray, M. A. Lumsden, J. Marsden, J. C Stevenson, and J. Williamson Non-estrogen-based treatments for menopausal symptoms Menopause Int, June 1, 2008; 14(2): 88 - 90. [Abstract] [Full Text] [PDF]

				C. Gordon, D. J. Wallace, S. Shinada, K. C. Kalunian, L. Forbess, G. D. Braunstein, and M. H. Weisman Testosterone patches in the management of patients with mild/moderate systemic lupus erythematosus Rheumatology, March 1, 2008; 47(3): 334 - 338. [Abstract] [Full Text] [PDF]

				E. M. Gurnell, P. J. Hunt, S. E. Curran, C. L. Conway, E. M. Pullenayegum, F. A. Huppert, J. E. Compston, J. Herbert, and V. K. K. Chatterjee Long-Term DHEA Replacement in Primary Adrenal Insufficiency: A Randomized, Controlled Trial J. Clin. Endocrinol. Metab., February 1, 2008; 93(2): 400 - 409. [Abstract] [Full Text] [PDF]

				K. K. Miller, B. M. K. Biller, A. Schaub, K. Pulaski-Liebert, G. Bradwin, N. Rifai, and A. Klibanski Effects of Testosterone Therapy on Cardiovascular Risk Markers in Androgen-Deficient Women with Hypopituitarism J. Clin. Endocrinol. Metab., July 1, 2007; 92(7): 2474 - 2479. [Abstract] [Full Text] [PDF]

				D. L. Barton, D. B. Wender, J. A. Sloan, R. J. Dalton, E. P. Balcueva, P. J. Atherton, A. M. Bernath Jr, W. L. DeKrey, T. Larson, J. D. Bearden III, et al. Randomized Controlled Trial to Evaluate Transdermal Testosterone in Female Cancer Survivors With Decreased Libido; North Central Cancer Treatment Group Protocol N02C3 J Natl Cancer Inst, May 2, 2007; 99(9): 672 - 679. [Abstract] [Full Text] [PDF]

				J. E. Potter A 60-Year-Old Woman With Sexual Difficulties JAMA, February 14, 2007; 297(6): 620 - 633. [Abstract] [Full Text] [PDF]

				S. Basaria and A. S. Dobs Controversies Regarding Transdermal Androgen Therapy in Postmenopausal Women J. Clin. Endocrinol. Metab., December 1, 2006; 91(12): 4743 - 4752. [Abstract] [Full Text] [PDF]

				J. H. Morrison, R. D. Brinton, P. J. Schmidt, and A. C. Gore Estrogen, Menopause, and the Aging Brain: How Basic Neuroscience Can Inform Hormone Therapy in Women J. Neurosci., October 11, 2006; 26(41): 10332 - 10348. [Full Text] [PDF]

				M. E. Wierman, R. Basson, S. R. Davis, S. Khosla, K. K. Miller, W. Rosner, and N. Santoro Androgen Therapy in Women: An Endocrine Society Clinical Practice Guideline J. Clin. Endocrinol. Metab., October 1, 2006; 91(10): 3697 - 3710. [Abstract] [Full Text] [PDF]

				D. J. Handelsman The Rationale for Banning Human Chorionic Gonadotropin and Estrogen Blockers in Sport J. Clin. Endocrinol. Metab., May 1, 2006; 91(5): 1646 - 1653. [Abstract] [Full Text] [PDF]

				K. K. Miller, B. M. K. Biller, C. Beauregard, J. G. Lipman, J. Jones, D. Schoenfeld, J. C. Sherman, B. Swearingen, J. Loeffler, and A. Klibanski Effects of Testosterone Replacement in Androgen-Deficient Women with Hypopituitarism: A Randomized, Double-Blind, Placebo-Controlled Study J. Clin. Endocrinol. Metab., May 1, 2006; 91(5): 1683 - 1690. [Abstract] [Full Text] [PDF]

				R. Basson Sexual Desire and Arousal Disorders in Women N. Engl. J. Med., April 6, 2006; 354(14): 1497 - 1506. [Full Text] [PDF]

				W. Arlt Androgen therapy in women Eur. J. Endocrinol., January 1, 2006; 154(1): 1 - 11. [Abstract] [Full Text] [PDF]

				A. B. Singh, M. L. Lee, I. Sinha-Hikim, M. Kushnir, W. Meikle, A. Rockwood, S. Afework, and S. Bhasin Pharmacokinetics of a Testosterone Gel in Healthy Postmenopausal Women J. Clin. Endocrinol. Metab., January 1, 2006; 91(1): 136 - 144. [Abstract] [Full Text] [PDF]