Menopause

Phase II/III clinical trial in climacteric symptoms

Published in Women's Health Weekly, March 27th, 2003

BioSante Pharmaceuticals, Inc., (BISP) announced that it has completed its phase II/III clinical trial of Bio-E-Gel (estradiol gel) topical gel for the treatment of menopausal symptoms, including hot flushes.

The trial, conducted in the United States and Canada, is a double-blind placebo-controlled study of 161 patients.

The objective of the phase II/III clinical trial is to define the lowest effective dose of Bio-E-Gel to reduce the severity and frequency of moderate- to-severe hot flushes in menopausal women. In 2001, BioSante completed two phase I/II Bio-E-Gel clinical trials which profiled the blood levels of estradiol delivered by two different...

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Source: Women's Health Weekly (2003-03-27)

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