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.
2 other identifiers
interventional
675
2 countries
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2008
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 5, 2009
CompletedFirst Posted
Study publicly available on registry
January 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJanuary 29, 2013
January 1, 2013
2.1 years
January 5, 2009
January 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Bleeding pattern indices
13 cycles
Cycle control parameters
13 cycles
Adverse events
Whole study period
Laboratory tests
Whole study period
Study Arms (1)
Arm 1
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy women between 18 and 45 requesting oral contraception.
- Smokers may not exceed 30 years of age.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (17)
Unknown Facility
Guangzhou, Guangdong, 510120, China
Unknown Facility
Guangzhou, Guangdong, China
Unknown Facility
Wuhan, Hubei, 430022, China
Unknown Facility
Nanjing, Jiangsu, 210006, China
Unknown Facility
Nanjing, Jiangsu, 210009, China
Unknown Facility
Yangzhou, Jiangsu, 225001, China
Unknown Facility
Shenyang, Liaoning, 110004, China
Unknown Facility
Jinan, Shandong, China
Unknown Facility
Xi’an, Shanxi, 710032, China
Unknown Facility
Chengdu, Sichuan, China
Unknown Facility
Beijing, 100034, China
Unknown Facility
Beijing, 100044, China
Unknown Facility
Chongqing, 400010, China
Unknown Facility
Chongqing, China
Unknown Facility
Shanghai, 200011, China
Unknown Facility
Shanghai, 200127, China
Unknown Facility
Hong Kong, Hong Kong
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 5, 2009
First Posted
January 8, 2009
Study Start
December 1, 2008
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
January 29, 2013
Record last verified: 2013-01