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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
635
Single dose administration of E2 + DRSP as a tablet
Single dose administration of E2 + DRSP as a tablet
Single dose administration of E2 + DRSP as a tablet
Single dose administration of E2 + DRSP as a tablet
Single dose administration of E2 + DRSP as a tablet
Single dose administration of DRSP as a tablet
Single dose administration of DRSP as a tablet
Placebo administration in each arm
Unnamed facility
Krumbach, Bavaria, Germany
Unnamed facility
Nuremberg, Bavaria, Germany
Unnamed facility
Hamburg, Hamburg, Germany
Unnamed facility
Hamburg, Hamburg, Germany
Unnamed facility
Dietzenbach, Hesse, Germany
Unnamed facility
Frankfurt am Main, Hesse, Germany
Unnamed facility
Frankfurt am Main, Hesse, Germany
Unnamed facility
Fulda, Hesse, Germany
Unnamed facility
Mühlheim am Main, Hesse, Germany
Unnamed facility
Dippoldiswalde, Saxony, Germany
...and 15 more locations
Number of intracyclic bleeding episodes during cycles 2 to 7
Time frame: 168 days
Number of intracyclic bleeding days (including spotting) in Cycles 2 to 7
Time frame: 168 days
Number of withdrawal bleeding episodes in Cycles 1 to 6
Time frame: 168 days
Bleeding pattern
Bleeding pattern was determined by: - Number of bleeding/spotting days - Number of bleeding days (excluding spotting) - Number of spotting-only days - Number, mean length, maximum length, and range of length of bleeding/spotting episodes - Number, mean length, maximum length, and range of length of spotting-only episodes
Time frame: Approximately 7 months
Cycle control
Withdrawal bleeding - Number of volunteers with/without withdrawal bleeding; - Length, maximum intensity, and onset of withdrawal bleeding episodes Intracyclic bleeding (including/excluding spotting) - Number of volunteers with/without intracyclic bleeding; - Number, maximum length, maximum intensity (including spotting only) of intracyclic bleeding episodes - Number of intracyclic bleeding days - Number of volunteers with at least one intracyclic bleeding (including/excluding spotting) episode in Cycles 2 - 6 and in Cycles 2 - 7
Time frame: Approximately 7 months
Subjective assessment of treatment
The treatment satisfaction assessment was done through a questionaire. The investigator handed it over to the subject and the subject was asked to answer all questions by herself.
Time frame: Day 196 - Day 210
Number of participants with adverse events
Time frame: Approximately 7 months
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