Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Antares Pharma and the Population Council, a non-profit research organization, have announced positive results from a prospective, open-label, dose-ranging pharmacokinetic Phase I trial for a novel contraceptive gel containing the progestin, Nestorone and the bio-identical estrogen, estradiol.
Subscribe to our email newsletter
The trial was designed to determine absorption of Nestorone and estradiol using the Advanced Transdermal Delivery (ATD) gel system. A total of 12 postmenopausal women were selected for the trial in order to avoid interference with the menstrual cycle of premenopausal women.
Data showed that an effective combined dose was identified that consistently delivered Nestorone. Serum levels following multiple administrations matched the target range expected to provide effective contraception. Serum levels for estradiol were also, on average, within the range for maintenance of regular bleeding patterns. The gel was well tolerated, with no serious adverse events recorded. Most subjects did not experience skin irritation at the site of application.
Dario Carrara, senior vice president and managing director for Antares, said: “We are pleased to present the preliminary data for Nestorone/estradiol ATD gel. The promising results obtained now from our joint Phase I study validate once again the capability of our ATD system to successfully deliver transdermally active substances in a broad variety of therapeutic fields. We are delighted with the results, as we believe a transdermal gel for contraception represents an excellent business opportunity in a large and growing market segment.”