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YAZ, Oral Contraceptive Registration in China

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00819312
First received: January 5, 2009
Last updated: January 27, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bleeding pattern indices [ Time Frame: 13 cycles ] [ Designated as safety issue: No ]
  • Cycle control parameters [ Time Frame: 13 cycles ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Whole study period ] [ Designated as safety issue: Yes ]
  • Laboratory tests [ Time Frame: Whole study period ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819312

Locations
China, Guangdong
Guangzhou, Guangdong, China, 510120
Guangzhou, Guangdong, China
China, Hubei
Wuhan, Hubei, China, 430022
China, Jiangsu
Nanjing, Jiangsu, China, 210009
Nanjing, Jiangsu, China, 210006
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, 200127
Shanghai, China, 200011
Hong Kong
Hongkong, Hong Kong
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to Bayer Healthcare products.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00819312     History of Changes
Other Study ID Numbers: 91619, 311041
Study First Received: January 5, 2009
Last Updated: January 27, 2013
Health Authority: China: State Food and Drug Administration (SFDA)

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

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Ethinyl Estradiol
Drospirenone
Drospirenone and ethinyl estradiol combination
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Aldosterone Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on June 18, 2013