The study will be performed as a multi-center, randomized, double-blind, parallel-group trial
in fertile women aged between 18 and 35 years inclusive. A total of 600 volunteers will be
randomized into one of the six treatment groups. The study will be performed only in Germany.
The investigational drug is an oral contraceptive. It contains the estrogen estradiol (E2)
and the progestogen drospirenone (DRSP). As the contraceptive efficacy has not yet been
proven for these new regimens, even a protection against unwanted pregnancies cannot be
assured. The treatments will be applied daily for 7 cycles of 28 days each without pill-free
interval, i.e., for 196 consecutive days. Treatment will be initiated after a screening
period of approximately 1 to 2 weeks, the latter focused on confirmation of the baseline
safety status. Tablet intake will start on the first day of the first menstrual/withdrawal
bleeding after Visit 2, regardless of whether the volunteer is a first user (starter) or
switching from another COC. In the following cycles, tablet intake is not to be triggered by
any bleeding events. The primary objective of this study is to evaluate and compare the cycle
control and bleeding patterns of six different treatment regimens with E2/DRSP during
administration for 7 treatment cycles. Volunteers will be provided with a diary to document
the intake of study medication, any bleeding events, and days without bleeding, pregnancy
test results. Safety will be also assessed. During the whole study period, 4 visits are
planned. At Screening and Final examination, a thorough physical examination and a
gynecological examination (including breast palpation and cervical smear ) will be performed.
Blood samples will be taken for safety laboratory parameters.Additional examinations can be
performed any time, if this becomes necessary for medical reasons. At Visit 3 or in case of
premature discontinuation of study the investigator will discuss options for follow-up
contraception with the volunteer. The volunteer can start the intake of a post-treatment OC
on the day after the last tablet intake of study medication, after a negative urine ß-HCG
test (home pregnancy test) result.