YAZ Post Authorization Safety Study (PASS)/Post Authorization Efficacy Study (PAES) in China

Inclusion criteria

• Signed and dated informed consent
• Chinese female subjects requesting oral contraception, including subjects who underwent abortion (medical or surgical)
• Planned use of combined oral contraceptives for at least 6 cycles
• Age: 18 to 45 years (inclusive); smokers must not be older than 35 years at the time of informed consent
• At least 4 weeks postpartum for women who are not breastfeeding or after a second trimester abortion

Exclusion criteria

• Evidence or suspicion of incomplete abortion (medical abortion subjects must have complete abortion confirmed by ultrasound [endometrial thickness ≤ 15 mm]).
• Pregnancy or lactation
• Menstrual disorders consistent with ovarian failure (eg, oligomenorrhea, amenorrhea, hypomenorrhea)
• Abuse of alcohol, drugs, or medicine (eg, laxatives)
• Inability to cooperate with the study procedures for any reason (eg, language comprehension, psychiatric illness, inability to get to the study site).
• Any diseases or conditions that can compromise the function of body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
• Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
• Any contraindication to YAZ according to the Chinese label, such as:

• Renal impairment
• Adrenal insufficiency
• A high risk of arterial or venous thromboembolic diseases. Examples include subjects who are known to:

• Have deep vein thrombosis or pulmonary embolism, now or in the past
• Have cerebrovascular disease
• Have coronary artery disease
• Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (eg, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)
• Have inherited or acquired hypercoagulopathies
• Have uncontrolled hypertension
• Have diabetes mellitus with vascular disease
• Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35
• Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past
• Liver tumors, benign or malignant, or liver disease
• Hypersensitivity to any ingredient of the study drug
• Undiagnosed abnormal genital bleeding
• Sterilized subjects or concomitant use of other hormonal contraception, intrauterine device (IUD), or intrauterine system (IUS) during the study
• For subjects qualifying for the moderate acne subgroup:

• Subjects with acne and atopy, comedonal acne or acne conglobata, sandpaper acne or acne with multiple large nodes, cysts, fistular comedones, or abscessing fistular ducts
• Use of preparations that have an acne-inducing effect (eg, iodinated or bromated drugs, tuberculostatics, lithium, vitamin B1 [>1.5 mg daily], B6 [>2 mg daily], B12 [>6 µg daily], corticoids, adrenocorticotropic hormone anabolics, quinine, disulfiram, methoxypsoralene, phenobarbital, phenytoin, trimethadione, thyroid depressants, and certain oily cosmetics)
• Subjects undergoing systemic acne treatment