Monocenter, Open-label, Randomized Study to Determine the Ovulation Inhibitory Effect of the Combined Oral Contraceptive SH T04769G and SH D00659AF (0.03 mg Ethinylestradiol and 2.0 mg Dienogest), Applied for Two Treatment Cycles to 60 Healthy Female Volunteers
The trial is sponsored by Bayer Schering Pharma AG, Germany.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary efficacy variable is ovulation inhibition in Cycle 2 (yes/no). Ovarian activity will be classified according to Hoogland and Skouby (1993).
4 cycles: one cycle before treatment followed by two treatment cycles (28 days each, 21 days with tablet intake followed by a 7-day tablet-free interval) one post-treatment cycle
Bayer Study Director
Germany: Federal Institute for Drugs and Medical Devices