Testosterone Patches Restore Hormone Blood Levels To Normal Range
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Testosterone Patches Restore Hormone Blood Levels To Normal Range

NEW ORLEANS, LA -- June 26, 1998 -- TheraTech Inc. presented results from a clinical trial on its transdermal testosterone and estradiol/testosterone combination patches for the treatment of testosterone deficiency in women at the Endocrine Society Conference this week in New Orleans.

These patches, which are designed to provide normal physiological replacement levels of testosterone for women, are being developed in collaboration with Procter & Gamble Pharmaceuticals, who upon regulatory approval will market the products on a world-wide basis excluding certain Asian countries.

Dr. Norman Mazer, vice president of clinical research at TheraTech, reported on the results from an initial study conducted with testosterone and estradiol/testosterone combination patches in surgically menopausal women with testosterone deficiency. The goal of the study, which was conducted by Dr. Angela Bowen, of the Middleton Foundation, Olympia, WA., was to determine the amount of testosterone and estradiol delivered by the patches.

On average, testosterone levels increased two-fold over baseline values in subjects treated with both the testosterone and estradiol/testosterone combination patches, restoring their testosterone blood levels to the normal range for women. Estradiol levels were also elevated in the surgically menopausal women when treated with the combination patch. Both patches were well tolerated in the study.

"These preliminary results demonstrate the feasibility of using transdermal patches to restore testosterone levels to the normal range in surgically menopausal women,” Dr. Mazer said.

Phase II clinical studies to assess the efficacy and safety of the testosterone patches for the treatment of decreased sexual function in surgically menopausal women are currently underway.

Generally considered as the male hormone, testosterone is produced by women, although at much lower levels than men. Currently, there are no products which provide physiological testosterone replacement for women suffering from testosterone deficiency. When testosterone is administered to women at doses higher than their normal physiological production, undesired side effects such as acne and increased facial hair can occur.

Testosterone deficiency in women can result from a variety of causes, including certain diseases, as well as natural and surgical menopause. Many physicians believe that testosterone deficiency is one of the most overlooked medical problems facing women today and that millions of women in the U.S. and Europe may experience testosterone deficiency.

Physiological testosterone replacement therapy could play an important role in restoring physical energy, sense of well being and sexual desire or libido, as well as providing positive effects on muscle strength and bone density in women.

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