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YAZ, Oral Contraceptive Registration in China

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00819312
First Posted: January 8, 2009
Last Update Posted: January 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  Purpose
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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.

Further study details as provided by Bayer:

Primary Outcome Measures:
  • The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment. [ Time Frame: 13 cycles (1 cycle= 28 days) ]

Secondary Outcome Measures:
  • Bleeding pattern indices [ Time Frame: 13 cycles ]
  • Cycle control parameters [ Time Frame: 13 cycles ]
  • Adverse events [ Time Frame: Whole study period ]
  • Laboratory tests [ Time Frame: Whole study period ]

Enrollment: 675
Study Start Date: December 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: YAZ (SH T00186, BAY86-5300)
20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00819312


Locations
China, Guangdong
Guangzhou, Guangdong, China, 510120
Guangzhou, Guangdong, China
China, Hubei
Wuhan, Hubei, China, 430022
China, Jiangsu
Nanjing, Jiangsu, China, 210006
Nanjing, Jiangsu, China, 210009
Yangzhou, Jiangsu, China, 225001
China, Liaoning
Shenyang, Liaoning, China, 110004
China, Shandong
Jinan, Shandong, China
China, Shanxi
Xi An, Shanxi, China, 710032
China, Sichuan
Chengdu, Sichuan, China
China
Beijing, China, 100034
Beijing, China, 100044
Chongqing, China, 400010
Chongqing, China
Shanghai, China, 200011
Shanghai, China, 200127
Hong Kong
Hongkong, Hong Kong
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00819312     History of Changes
Other Study ID Numbers: 91619
311041 ( Other Identifier: company internal )
First Submitted: January 5, 2009
First Posted: January 8, 2009
Last Update Posted: January 29, 2013
Last Verified: January 2013

Keywords provided by Bayer:
Contraceptives,
Oral Hormonal;
Contraceptive Methods;
Female

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Drospirenone
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Estrogens
Hormones