Landmark Clinical Study Shows Female Testosterone Patch Significantly Improved Sexual Desire in Surgically Menopausal Women

  Women In Study Reported 74% Increase in Frequency of Satisfying Sexual Activity

  Data from a landmark Phase III safety and efficacy study of 562 women showed treatment with an investigational female testosterone patch significantly increased satisfying sexual activity and desire in patients with Hypoactive Sexual Desire Disorder (HSDD), who previously had both ovaries removed.  HSDD is defined as a lack of sexual desire that causes a woman personal distress.  The preliminary findings of the study were presented today during the 52nd Annual Clinical Meeting of The American College of Obstetricians and Gynecologists (ACOG).

"As a physician who has been treating menopausal women with sexual difficulties for over 30 years, I know how distressing loss of sexual drive can be for both women and their partners," said Professor Alan Riley, professor of Sexual Medicine at the Lancashire Postgraduate School of Medicine and Health, University of Central Lancashire . "This is exciting news as we have had to treat many of these women with products that have been designed for men.  An effective and safe therapeutic option for enhancing sexual desire following surgical menopause will fulfill an important medical need.  We hope we are one step closer to providing an approved treatment."

The study of 562 surgically menopausal women with HSDD showed patients receiving testosterone via a transdermal patch experienced a 74 percent increase in the frequency of total satisfying sexual activity, as well as a 56 percent increase in sexual desire versus baseline.  The increases were statistically significant versus baseline and placebo.  Significant improvements were also seen in other aspects of HSDD -- arousal, orgasm, pleasure, responsiveness, concerns and distress levels -- in women using the testosterone patch.  Overall, adverse event reports were comparable to placebo, the most common being application site reaction, upper respiratory infection and headache.

ABOUT TESTOSTERONE & THE FEMALE PATCH

Testosterone is produced naturally in a woman's ovaries and adrenal glands and has long been linked to female sexual function.  When a woman has her ovaries surgically removed, she experiences an immediate decline in testosterone.  The loss of sexual desire can be a consequence of that testosterone drop.  According to a recent study, an estimated one in three surgically menopausal women in France , Italy , Germany and the UK has low sexual desire, and one-fifth of these women studied reported being distressed about it.(1)  Low desire is the most commonly reported type of female sexual health problem.

In the study, the thin, transparent testosterone patch was worn on the abdomen and worked by releasing a low, controlled dose of natural, plant- derived testosterone.  Procter & Gamble Pharmaceuticals formed a joint collaboration with Watson Pharmaceuticals, Inc., to develop the testosterone patch.  There are currently no products approved in Europe to treat HSDD in women.

ABOUT THE STUDY

The 24-week, randomised, double-blind, multi-centre study, called INTIMATE SM 1, enrolled surgically menopausal women with HSDD who were taking oral or transdermal oestrogen.  Patients were on average 49 years old, were in stable relationships (mean of 19 years), and had their ovaries removed an average of 8-1/2 years before study entry.  Patients were randomised to receive a placebo patch or the female testosterone patch designed to deliver 300 micrograms (mcg) of testosterone per day.  All patches were changed twice weekly.

In the study, the primary efficacy endpoint was the change in total satisfying sexual activity, as recorded in a Sexual Activity Log (SAL), at 24 weeks.  The Profile of Female Sexual Function (PFSF) and Personal Distress Scale (PDS), two multinational, validated instruments,(2) measured seven domains of sexual function (desire, arousal, orgasm, pleasure, responsiveness, concerns and self-image), and distress associated with low desire, respectively.

This study was sponsored by Procter & Gamble Pharmaceuticals and conducted at The Women's Health Research Center and 51 other centres in the U.S. , Canada and Australia .

(1) Leiblum S, Koochaki P, Rodenberg C, Rosen R.  Prevalence of Low  Sexual Desire and Sexual Activity Levels Among Populations of Menopausal Women.  NAMS Oral presentation 2002.

(2) Derogatis L, Rust J, Golombok S, et al.  Validation of the profile of female sexual function (PFSF) in surgically and naturally menopausal women.  J Sex Marital Ther. 2004;30:25-36.

Web site:  http://www.pgpharma.com               http://www.eu.pg.com

Source: Procter & Gamble

(5/5/04)