Phase III clinical trial of Bio-E-Gel initiated.

2003 NOV 6 - (NewsRx.com & NewsRx.net) -- BioSante Pharmaceuticals, Inc., (BPA) announced that it has initiated a pivotal phase III clinical trial of Bio-E-Gel (estradiol topical gel) for the treatment of moderate-to-severe hot flushes and vaginal atrophy in menopausal women.

The phase III trial will be conducted in the United States and Canada and is a randomized, double-blind, placebo-controlled study of symptomatic menopausal women. This trial follows successful completion of a phase II/III clinical study and two dose-ranging phase II clinical trials, which demonstrated that Bio-E-Gel topical gel successfully delivers therapeutic doses of bioidentical estradiol and statistically significantly reduces the frequency and severity of hot flushes.

Current U.S. Food and Drug Administration (FDA) requirements for approval of new estradiol products include one 12-week phase III clinical trial. The clinical endpoints of the required phase III trial include a significant reduction in the severity and frequency of hot flushes at week 4 and week 12 of treatment as compared to placebo. The Bio-E-Gel phase III clinical trial will test two doses of Bio-E-Gel to maximize the safety profile by identifying the lowest effective dose.

"We are extremely excited to move into this phase III study of Bio-E-Gel," said Stephen M. Simes, president and chief executive officer of BioSante. "This is the first phase III trial to be initiated by BioSante, a very important milestone for the company. We have been committed to moving our pipeline of hormone therapy products through clinical trials, and we now have four hormone therapy products in clinical development."

The objective of the completed phase II/III clinical trial was to identify an effective dose of Bio-E-Gel to study in phase III development. The phase II/III trial demonstrated that Bio-E-Gel effectively reduces the severity and frequency of moderate-to-severe hot flushes in menopausal women, according to FDA guidances for development of estrogen products.

Additionally, Bio-E-Gel delivers bioidentical estradiol evenly over time without significant fluctuations in blood levels, such as those typically associated with hormone tablets. Furthermore, even though Bio-E-Gel was applied daily to the same site, minimal skin irritation, a side-effect often associated with ...