Contraception
Conditions
Keywords
Efficacy, Safety, oral contraception, estradiol valerate, dienogest
Brief summary
To evaluate the efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in healthy female subjects.
Interventions
Oral estradiol valerate and dienogest (2 days 3.0 mg estradiol valerate (EV), 5 days 2.0 mg EV + 2.0 mg dienogest (DNG), 17 days 2.0 mg EV + 3.0 mg DNG, 2 days 1.0 mg EV, 2 days placebo), one table oral daily for 13 treatment cycles (1 cycle = 28days)
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy women between 18 and 50 for the entire study, except women enrolled from India should be aged between 18 and 40 years, requesting contraception * Smokers may not exceed 35 years of age
Exclusion criteria
* Pregnancy or lactation (delivery, abortion, or lactation within less than three cycles before the start of treatment) * Body mass index (BMI) \> 32 kg/m2 * Any disease or condition that may worsen under hormonal treatment * Undiagnosed abnormal genital bleeding * Other contraceptive methods such as sterilization, hormonal contraception, IUD within 30 days of Visit 1, monthly contraceptive injection within a period of three times of the injection interval before start of treatment * Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of unintended pregnancies | Up to Cycle 13 (1 Cycle = 28 days) |
Secondary
| Measure | Time frame |
|---|---|
| Number of expected bleeding days | Up to Cycle 13 (1 Cycle = 28 days) |
| Number of unexpected bleeding days | Up to Cycle 13 (1 Cycle = 28 days) |
| Number of expected bleeding episodes | Up to Cycle 13 (1 Cycle = 28 days) |
| Number of unexpected bleeding episodes | Up to Cycle 13 (1 Cycle = 28 days) |
| Number of participants with Adverse Events as a Measure of Safety and Tolerability | Up to Cycle 13 (1 Cycle = 28 days) |
Countries
China, Hong Kong, India, Taiwan, Thailand
Outcome results
None listed