Testosterone Patch Increases Sexual Activity and Desire in Surgically Menopausal Women with Hypoactive Sexual Desire Disorder (original) (raw)

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1Women’s Health Research Center (J.S.), Laurel, Maryland 20707;

*Address all correspondence and requests for reprints to: Dr. James Simon, 14201 Laurel Park Drive Suite 104, Laurel, Maryland 20707.

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2Cedars-Sinai Medical Center (G.B.), Los Angeles, California 90048;

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3New York University School of Medicine (L.N.), New York, New York 10016;

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4Rapid Medical Research (W.U.), Cleveland, Ohio 44122;

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5Katz, Kade, and Hewitt, Inc. (M.K.), Cincinnati, Ohio 45219;

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6S. A. M. Clinical Research Center (S.M.), San Antonio, Texas 78229;

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7Downtown Women’s Health Care (A.W.), Denver, Colorado 80202;

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8Clinique RSF, Inc. (C.B.), Quebec, Canada G1S 2L6;

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9St. Michael’s Hospital Health Center (C.D.), Toronto, Canada M5B 1W8;

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10Procter & Gamble Pharmaceuticals Health Care Research Center (A.B., C.R., J.L.), Mason, Ohio 45040;

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Received:

01 September 2004

Published:

01 September 2005

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James Simon, Glenn Braunstein, Lila Nachtigall, Wulf Utian, Molly Katz, Sam Miller, Arthur Waldbaum, Celine Bouchard, Christine Derzko, Akshay Buch, Cynthia Rodenberg, Johna Lucas, Susan Davis, Testosterone Patch Increases Sexual Activity and Desire in Surgically Menopausal Women with Hypoactive Sexual Desire Disorder, The Journal of Clinical Endocrinology & Metabolism, Volume 90, Issue 9, 1 September 2005, Pages 5226–5233, https://doi.org/10.1210/jc.2004-1747
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Abstract

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.

Copyright © 2005 by The Endocrine Society

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