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Trial record 46 of 101 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND ethinylestradiol

YAZ, Oral Contraceptive Registration in China

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ClinicalTrials.gov Identifier: NCT00819312
Recruitment Status : Completed
First Posted : January 8, 2009
Last Update Posted : January 29, 2013
Sponsor:
Information provided by:
Bayer

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.

Condition or disease Intervention/treatment Phase
Contraception Drug: YAZ (SH T00186, BAY86-5300) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 675 participants
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.
Study Start Date : December 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Arm Intervention/treatment
Active Comparator: Arm 1 Drug: YAZ (SH T00186, BAY86-5300)
20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd




Primary Outcome Measures :
  1. 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 :
  1. Bleeding pattern indices [ Time Frame: 13 cycles ]
  2. Cycle control parameters [ Time Frame: 13 cycles ]
  3. Adverse events [ Time Frame: Whole study period ]
  4. Laboratory tests [ Time Frame: Whole study period ]


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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).

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
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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
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Study Director: Bayer Study Director Bayer

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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 Posted: January 8, 2009    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013
Keywords provided by Bayer:
Contraceptives,
Oral Hormonal;
Contraceptive Methods;
Female
Additional relevant MeSH terms:
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Drospirenone
Ethinyl Estradiol
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents