check_circleStudy Completed

Contraception

Bayer Identifier:

91619

ClinicalTrials.gov Identifier:

NCT00819312

EudraCT Number:

Not Available

EU CT Number:

Not Available
YAZ, Oral Contraceptive registration in China

Trial 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.

Key Participants Requirements

Sex

Female

Age

18 - 45 Years
  • -Healthy women between 18 and 45
    requesting oral contraception.
    -Smokers may not exceed 30 years of age.
  • -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).

Trial summary

Enrollment Goal
675
Trial Dates
December 2008 - January 2011
Phase
Phase 3
Could I Receive a placebo
No
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Peking University First HospitalBeijing, 100034, China
Completed
Chongqing Medical University Second HospitalChongqing, 400010, China
Completed
Tongji Hosp Tongji Med College of Huazhong University of SciWuhan, 430022, China
Completed
Xijing Hospital, the 4th Military Medical UniversityXi An, 710032, China
Completed
Southeast University affilitated Zhongda HospitalNanjing, 210009, China
Completed
The Obs. and Gyn. Hospital of Medical Center of Fudan UniverShanghai, 200011, China
Completed
Shanghai second Medical University, Shanghai Ren Ji HospitalShanghai, 200127, China
Completed
Peking University People's HospitalBeijing, 100044, China
Completed
West China Second University Hospital of Sichuan UniversityChengdu, China
Completed
1st hospital of Chongqing Medical UniversityChongqing, China
Completed
Shengjing Hospital of China Medical UniversityShenyang, 110004, China
Completed
Qi Lu hospital of Shandong UniversityJinan, China
Completed
The Third Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, China
Completed
Nanjing First HopitalNanjing, 210006, China
Completed
Subei People's Hospital of Jiangsu ProvinceYangzhou, 225001, China
Completed
The Second Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, 510120, China
Completed
Queen Mary Hospital, University of Hong KongHongkong, Hong Kong

Primary Outcome

  • The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment.
    date_rangeTime Frame:
    13 cycles (1 cycle= 28 days)
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Bleeding pattern indices
    date_rangeTime Frame:
    13 cycles
    enhanced_encryption
    Safety Issue:
    no
  • Cycle control parameters
    date_rangeTime Frame:
    13 cycles
    enhanced_encryption
    Safety Issue:
    no
  • Adverse events
    date_rangeTime Frame:
    Whole study period
    enhanced_encryption
    Safety Issue:
    yes
  • Laboratory tests
    date_rangeTime Frame:
    Whole study period
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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