Hormone Replacement Therapy

Enrollment completed for Phase III clinical trial for estrogen gel

Published in OBGYN and Reproduction Week, February 7th, 2005

BioSante Pharmaceuticals, Inc. (Amex:BPA) says it has reached its enrollment target of over 450 women in the company's pivotal Phase III clinical trial to evaluate the safety and efficacy of Bio-E-Gel (bioidentical estradiol transdermal gel) for the treatment of moderate-to-severe hot flashes in menopausal women.

Hot flashes occur in up to 85% of menopausal women.

"Completing enrollment in our Phase III Bio-E-Gel trial is an important milestone that brings BioSante one step closer to a new drug application (NDA) and commercialization of Bio-E-Gel," said Stephen M. Simes, BioSante. "We are confident in the potential of Bio-E-Gel to help women better...

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Source: OBGYN and Reproduction Week (2005-02-07)

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