Status:
COMPLETED
YAZ, Oral Contraceptive Registration in China
Lead Sponsor:
Bayer
Conditions:
Contraception
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Healthy women between 18 and 45 requesting oral contraception.
- Smokers may not exceed 30 years of age.
Exclusion
- 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).
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
675 Patients enrolled
Trial Details
Trial ID
NCT00819312
Start Date
December 1 2008
End Date
January 1 2011
Last Update
January 29 2013
Active Locations (17)
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1
Guangzhou, Guangdong, China, 510120
2
Guangzhou, Guangdong, China
3
Wuhan, Hubei, China, 430022
4
Nanjing, Jiangsu, China, 210006