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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00819312 |
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.
Condition | Intervention | Phase |
---|---|---|
Contraception |
Drug: YAZ (SH T00186, BAY86-5300) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 670 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental |
Drug: YAZ (SH T00186, BAY86-5300)
20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
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Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com | |
Contact: (Phone Menu Options '3' or '4') | (+)1-888-84 22937 |
China | |
Recruiting | |
Shanghai, China, 200011 | |
Recruiting | |
Shanghai, China, 200127 | |
Not yet recruiting | |
Beijing, China, 100034 | |
Not yet recruiting | |
Beijing, China, 100044 | |
Recruiting | |
Chongqing, China, 400016 | |
Recruiting | |
Chongqing, China, 400010 | |
China, Guangdong | |
Recruiting | |
Guangzhou, Guangdong, China, 510630 | |
China, Hubei | |
Recruiting | |
Wuhan, Hubei, China, 430030 | |
China, Jiangsu | |
Recruiting | |
Nanjing, Jiangsu, China, 210009 | |
China, Liaoning | |
Recruiting | |
Shenyang, Liaoning, China, 110003 | |
China, Shandong | |
Not yet recruiting | |
Jinan, Shandong, China, 250012 | |
China, Shanxi | |
Recruiting | |
Xi'an, Shanxi, China, 710032 | |
China, Sichuan | |
Recruiting | |
Chengdu, Sichuan, China, 610041 | |
Hong Kong | |
Not yet recruiting | |
Hong Kong, Hong Kong |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Schering Pharma AG ( Therapeutic Area Head ) |
Study ID Numbers: | 91619, 311041 |
Study First Received: | January 5, 2009 |
Last Updated: | May 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00819312 History of Changes |
Health Authority: | China: State Food and Drug Administration (SFDA) |
Contraceptives, Oral Hormonal; Contraceptive Methods; Contraceptives, Female |
Estrogens Contraceptive Agents Hormone Antagonists Contraceptives, Oral Estradiol valerate Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Ethinyl Estradiol |
Healthy Estradiol 17 beta-cypionate Hormones Estradiol Estradiol 3-benzoate Drospirenone Polyestradiol phosphate |
Estrogens Contraceptive Agents Therapeutic Uses Physiological Effects of Drugs Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists |
Contraceptive Agents, Female Ethinyl Estradiol Reproductive Control Agents Hormones Pharmacologic Actions |