Register for Women's Sexual Dysfunction Programs Expanded
Testosterone DeficiencyJanuary 11, 2001
(NewsRx.com & NewsRx.net) -- Cellegy Pharmaceuticals, Inc. (CLGY), San Francisco, California, announced that it has initiated an expanded Phase I/II clinical trial of Tostrelle, its transdermal testosterone gel product for female sexual dysfunction.
Testosterone deficiency in women frequently leads to diminished libido, and decreased muscle/bone mass and energy level.
Additionally, Cellegy announced it is sponsoring a collaborative research program focusing on a specific female sexual disorder at the University of California, Los Angeles, Medical Center. The program will be conducted by Jennifer Berman, MD.
Cellegy is currently enrolling surgically-induced menopausal women on estrogen replacement therapy for the expanded Phase I/II study in the United Kingdom. This study is designed to determine the optimal dosing regimen of Tostrelle in women who have undergone oophorectomy and hysterectomy.
The company successfully completed a Phase I/II trial in September 2000, which evaluated serum testosterone concentrations following varying doses of Tostrelle given to 18 naturally menopausal women. The trial, which was conducted at two medical centers in the U.S., demonstrated that bioavailable testosterone levels, similar to those in young women, could be achieved in women on hormone replacement therapy without significant adverse events.
The collaborative research studies at UCLA will explore the use of a Cellegy topical compound to establish proof of efficacy in the treatment of a specific non-hormone-related female sexual disorder.
This article was prepared by Women's Health Weekly editors from staff and other reports.
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