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
18 Years
35 Years
Female
Oral Contraceptive
Trial Information
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.
Inclusion Criteria:
- Healthy female volunteers, aged 18 - 35 years (smokers up to 30 years)
- Willingness to apply non-hormonal methods of contraception during the course of the
study (e.g., condom with spermicide, diaphragm with spermicide)
- Confirmation of ovulation during the cycle before treatment
- Normal routine blood values
Exclusion Criteria:
- Contraindications for the use of oral contraceptives
- Pregnancy, lactation
- Simultaneous participation in another clinical study
- Considerable overweight
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary efficacy variable is ovulation inhibition in Cycle 2 (yes/no). Ovarian activity will be classified according to Hoogland and Skouby (1993).
Outcome Time Frame:
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
Safety Issue:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
91539
NCT ID:
NCT00471991
Start Date:
April 2007
Completion Date:
December 2007
Related Keywords:
- Oral Contraceptive
- Oral contraceptive
- ovulation inhibitory effect
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