Cycle Control and Safety of E2-DRSP
Condition: Contraceptive, Oral, Hormonal
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    


Intervention name(s): E2/DRSP (BAY 86-4891) dose 1 (SH T04984E); E2/DRSP (BAY 86-4891) dose 2 (80458739); E2/DRSP (BAY 86-4891) dose 3 (80458755); E2/DRSP (BAY 86-4891) dose 4 (80458720); E2/DRSP (BAY 86-4891) dose 5 (80458712); DRSP (ZK 30595) dose 1 (SH T04984F); DRSP (ZK 30595) dose 2 (80458690); Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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
Intervention MeSH terms: Drospirenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Oral contraception