Menopause

Pivotal phase III trial for estrogen gel completed

Published in Drug Week, May 13th, 2005

BioSante Pharmaceuticals, Inc., (BPA) announced the completion of its 12-week 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.

"The completion of our 483-patient Bio-E-Gel trial brings us closer to filing a new drug application (NDA) and reaching our goal of commercializing this important new therapy," said Stephen M. Simes, president and chief executive officer of BioSante. "We are confident in Bio-E-Gel's potential to help menopausal women better manage...

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Source: Drug Week (2005-05-13)

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