YAZ, Oral Contraceptive Registration in China
Information source: Bayer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: YAZ (SH T00186, BAY86-5300) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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.
Clinical Details
Official title: A Multicenter, Open-label, Single-arm Study to Investigate the Efficacy and Safety of the Oral Contraceptive YAZ (20μg Ethinylestradiol, 3mg Drospirenone) for 13 Cycles in 670 Healthy Chinese Female Volunteers.
Study design: Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment.
Secondary outcome: Bleeding pattern indicesCycle control parameters Adverse events Laboratory tests
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
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).
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Shanghai 200011, China; Recruiting
Shanghai 200127, China; Recruiting
Beijing 100034, China; Recruiting
Beijing 100044, China; Not yet recruiting
Chongqing 400016, China; Recruiting
Chongqing 400010, China; Recruiting
Hong Kong, Hong Kong; Recruiting
Guangzhou, Guangdong 510630, China; Recruiting
Guangzhou, Guangdong 510120, China; Recruiting
Wuhan, Hubei 430030, China; Recruiting
Nanjing, Jiangsu 210009, China; Recruiting
Nanjing, Jiangsu 210006, China; Recruiting
Yangzhou, Jiangsu 225001, China; Recruiting
Shenyang, Liaoning 110003, China; Recruiting
Jinan, Shandong 250012, China; Recruiting
Xi'an, Shanxi 710032, China; Recruiting
Chengdu, Sichuan 610041, China; Recruiting
Additional Information
Click here and search for drug information provided by the FDA Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product Click here to find results for studies related to marketed products
Starting date: December 2008
Ending date: January 2011
Last updated: October 1, 2009
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