YAZ, Oral Contraceptive Registration in China
Phase 3
Completed
- Conditions
- Contraception
- Interventions
- Drug: YAZ (SH T00186, BAY86-5300)
- Registration Number
- NCT00819312
- Lead Sponsor
- Bayer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 675
Inclusion Criteria
- Healthy women between 18 and 45 requesting oral contraception.
- Smokers may not exceed 30 years of age.
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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).
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 YAZ (SH T00186, BAY86-5300) -
- Primary Outcome Measures
Name Time Method The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment. 13 cycles (1 cycle= 28 days)
- Secondary Outcome Measures
Name Time Method Bleeding pattern indices 13 cycles Cycle control parameters 13 cycles Adverse events Whole study period Laboratory tests Whole study period