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Transdermal Testosterone Gel Looks Like Promising Therapy.(Brief Article)
2001 OCT 4 - (NewsRx.com & NewsRx.net) --
Cellegy Pharmaceuticals, Inc. (CLGY) announced that it has successfully completed a second Phase I/II clinical trial using Tostrelle, its transdermal testosterone gel product for the treatment of female sexual dysfunction.
Testosterone deficiency in women frequently leads to diminished libido, decreased muscle/bone mass, and reduced energy levels. A meeting has been requested with the U.S. Food and Drug Administration (FDA) to review results of trials conducted to date and Cellegy's proposed protocol for an advanced efficacy trial.
The 36-patient trial, conducted in the United Kingdom, was designed to determine the dose of Tostrelle required to safely restore normal testosterone levels in surgically-induced menopausal women on various forms of estrogen replacement therapy. The trial achieved all of the desired endpoints.
Late last year (2000), Cellegy successfully completed an initial Phase I/II trial which evaluated serum testosterone concentrations following varying doses of Tostrelle given to 18 naturally menopausal women. That trial, which was conducted at two medical centers in the United States, also demonstrated that bioavailable testosterone ...
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