Organon starts Ph III NOMAC/E2 trials

Dutch drugmaker Organon, the human health care business of Akzo Nobel, says that it has begun Phase III assessment of the novel combined oral contraceptive NOMAC/E2, which it licenses from German drugmaker Merck KGaA's French affiliate Laboratoire Theramex, under a deal established last year.

The drug contains natural estradiol identical to that produced in women's bodies, thereby differing from other current oral contraceptives which contain the synthetic version, ethinyl estradiol. Phase II trials conducted by Theramex, have established the product's efficacy and safety.

Organon explained that the Phase III program would include two large-scale, randomized, open-label comparative trials, which would seek to enroll 4,200 women and generate data from 30,000 plus cycles of exposure to the drug. The trials will be conducted at more than 200 research centers around the world, including several in the USA.