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Phase I Trials Evaluate Seven-Day Combination Patches.(Brief Article)
2001 SEP 13 - (NewsRx.com & NewsRx.net) -- Agile Therapeutics, Inc. (formerly Levotech, Inc.), announced that two Phase I clinical trials have begun enrollment. The goal of these trials is to evaluate the safety of two new seven-day transdermal formulas for birth control.
Approximately 15 subjects will be evaluated in each of the two trials. Each trial will run 30 days and will measure blood levels of levonorgestrel and ethinyl estradiol. When these trials are completed, Phase II trials will begin with each formula to determine ability to inhibit ovulation.
Agile Therapeutics currently is conducting two Phase II trials using its original formulation in 7.5 cm(2) and 9 cm(2) patches. A total of 90 subjects have been enrolled. These eight-month trials are scheduled for completion in the first half of 2002.
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