Efficacy and Safety of a Combined Oral Contraceptive of Estradiol Valerate and Dienogest in Healthy Female Subjects

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in healthy female subjects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Dienogest; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Nandrolone; Polyestradiol phosphate

Criteria

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