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William B White, Deborah Grady, Linda C Giudice, Scott M Berry, Joanne Zborowski, Michael C Snabes
Evaluation of the safety of hormonal preparations for the treatment of female sexual dysfunction is important to assess the benefit-to-risk profile of these drugs and has been strongly encouraged by the Food and Drug Administration. LibiGel (Biosante Pharmaceuticals, Inc., Lincolnshire, IL), a low-dose testosterone gel, is under development for the treatment of hypoactive sexual desire disorder (HSDD) in oophorectomized women. To evaluate the long-term effects of LibiGel on risk for cardiovascular (CV) events, breast cancer, and general safety, a randomized, placebo-controlled clinical study using a novel adaptive design to optimize sample size and power is being conducted...
January 2012: American Heart Journal
Jill M Krapf, James A Simon
At least 16 million women over the age of 50 currently experience low sexual desire, with approximately 4 million women exhibiting hypoactive sexual desire disorder (HSDD). Although early research established that testosterone therapy improves sexual desire in postmenopausal women, safer and more efficacious administration routes were explored. Large randomized, double-blinded placebo-controlled studies demonstrate that transdermal testosterone improves sexual function and activity in postmenopausal women with HSDD...
July 20, 2009: Maturitas
Michael C Snabes, Stephen M Simes
INTRODUCTION: Despite a high prevalence of hypoactive sexual desire disorder (HSDD), no medical treatment is available in the United States for this condition. AIM: To identify the current prescribing pattern of off-label testosterone use in treating HSDD. MAIN OUTCOME MEASURES: Quantitation of Intercontinental Marketing Services (IMS) prescription data to identify testosterone prescriptions written for women and a summary of response to queries to opinion leaders and practicing physicians...
July 2009: Journal of Sexual Medicine
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