YAZ, Oral Contraceptive Registration in China

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive YAZ in healthy Chinese women.

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

Details

• Lead Sponsor: Bayer
• Treatments: Contraceptive Agents; Contraceptives, Oral; Drospirenone; Ethinyl Estradiol

Criteria

Inclusion Criteria:

• Healthy women between 18 and 45 requesting oral contraception.

• Smokers may not exceed 30 years of age.

Exclusion Criteria:

• The use of steroidal oral contraceptives , or any drug that could alter oral contraception metabolism will be prohibited during the study.

• Pregnancy, lactation (less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment)

• Menstrual disorders suspicious of ovarian failure (e.g. oligomenorrhea, amenorrhea, hypomenorrhea

• Any disease or condition that may worsen under hormonal treatment

• Other contraceptive methods such as sterilization or IUD/IUS

• Substantial overweight (BMI > 30 kg/m2).