YAZ, Oral Contraceptive Registration in China

Bayer

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: YAZ (SH T00186, BAY86-5300)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00819312

311041 (Other Identifier)

91619

Details and patient eligibility

About

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.

Enrollment: 675 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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675 participants in 1 patient group

Arm 1

Active Comparator group

Treatment:

Drug: YAZ (SH T00186, BAY86-5300)