EWING, N.J.--(BUSINESS WIRE)--Antares Pharma, Inc. (AMEX:AIS) and the Population Council have initiated a Phase I pharmacokinetic clinical program in twelve healthy, post-menopausal women using Antares’ ATD™ transdermal gel to deliver nestorone and estradiol in two separate treatment periods. In the first period there will be a single administration of two different doses of nestorone concurrently with estradiol and in the second treatment period the most effective combined dose of nestorone and estradiol will be tested as once daily dosing for ten consecutive days. The primary objectives of the studies include determining the pharmacokinetic profile of the nestorone component of the nestorone/estradiol combination ATD™ gel delivered transdermally and determining the necessary nestorone dose to achieve the appropriate therapeutic levels for effective contraception. Secondary objectives include determining the profile of estradiol needed to reach estrogen replacement levels and to maintain regular bleeding patterns and evaluating local skin irritation and tolerability of the nestorone/estradiol combination ATD™ gel.
