Pivotal phase IIIa trials for Organon's novel oral contraceptive, NOMAC/E2, complete recruitment
Organon announced that it has now completed recruitment for both pivotal phase IIIa trials for NOMAC/E2, its novel oral contraceptive containing natural estrogen. According to the company, the success means the development program is on track for file submission in 2009.
NOMAC/E2 is the first monophasic oral contraceptive containing natural estrogen. It contains the estrogen estradiol (E2), which is similar to the one naturally present in the woman's body. All currently available combined oral contraceptives contain synthetic ethinyl-estradiol (EE), a chemically modified version of estrogen. The new combined pill also contains NOMAC (nomegestrol acetate), a hormone new in contraception, which resembles the progesterone a woman's body produces at certain times in her menstrual cycle.
The phase IIIa development program for NOMAC/E2 started in June 2006. The two large, randomized, open-label multi-centre, 13-cycle, comparative studies designed to evaluate the efficacy, cycle control, safety and acceptability of NOMAC/E2, will generate more than 30,000 cycles of exposure to NOMAC/E2. In total more than 180 centers in 24 countries including the USA, are taking part. Potential product pluses and non-contraceptive benefits specifically related to the use of this unique combination are under investigation in both trials. A number of smaller studies designed to assess the pharmacodynamic and metabolic aspects of NOMAC/E2 as required by the regulatory guidelines for development of a new contraceptive product are also underway.
Organon was granted development and marketing rights of NOMAC/E2 in 2005 by Laboratoire Théramex, an affiliate of Merck KGaA of Darmstadt, Germany. Théramex completed the phase II program indicating that NOMAC/E2 combines inhibition of ovulation with a stable bleeding pattern.
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