YAZ, Oral Contraceptive Registration in China

A Multicenter, Open-label, Single-arm Study to Investigate the Efficacy and Safety of the Oral Contraceptive YAZ (20 μg Ethinylestradiol, 3 mg Drospirenone) for 13 Cycles in 670 Healthy Chinese Female Volunteers.

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.

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).