Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448)
Status:
Terminated
Trial end date:
2014-02-12
Target enrollment:
Participant gender:
Summary
The purpose of this study was to assess the contraceptive efficacy of a nomegestrol acetate +
17ß-estradiol (NOMAC-E2) combined oral contraceptive (COC) in healthy, sexually-active
American women at risk for pregnancy. Vaginal bleeding patterns of women taking NOMAC-E2 were
assessed and compared to those of women taking a norethisterone acetate + ethinyl estradiol
(NETA-EE) COC. The safety of NOMAC-E2 was also assessed.
Participants were randomized to receive either NOMAC-E2 or NETA-EE in a 3:1 ratio. As of
Amendment 1 (which increased the sample size of the NOMAC-E2 group), the randomization ratio
was adapted accordingly for participants randomized after the sample size increase.