Cellegy reports positive Tostrelle data
This article was originally published in Pharmaceutical Approvals Monthly
Cellegy has begun preparations to move its testosterone gel product Tostrelle into Phase III following discussions with FDA and a positive interim analysis of a Phase II trial in postmenopausal women with low testosterone levels and sexual dysfunction symptoms. The 103-patient, four-month study showed a 65% improvement in number of satisfying sexual events (a 30% increase over placebo). Serum testosterone levels were also brought into normal physiologic range (p<0.001). Cellegy has halted enrollment in the Phase II trial...
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