YAZ, Oral Contraceptive Registration in China

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.

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: YAZ (SH T00186, BAY86-5300)

• Study Type: Interventional
• Enrollment (Actual): 675
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100044
  • Beijing, China, 100034
  • Chongqing, China
  • Chongqing, China, 400010
  • Shanghai, China, 200127
  • Shanghai, China, 200011
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
    • Guangzhou, Guangdong, China
  • Hubei
    • Wuhan, Hubei, China, 430022
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
    • Nanjing, Jiangsu, China, 210009
    • Yangzhou, Jiangsu, China, 225001
  • Liaoning
    • Shenyang, Liaoning, China, 110004
  • Shandong
    • Jinan, Shandong, China
  • Shanxi
    • Xi An, Shanxi, China, 710032
  • Sichuan
    • Chengdu, Sichuan, China
• Hong Kong
  • Hongkong, Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Arm 1	Drug: YAZ (SH T00186, BAY86-5300); 20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	Whole study period
Laboratory tests	Whole study period
Bleeding pattern indices	13 cycles
Cycle control parameters	13 cycles

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): January 1, 2011

Study Registration Dates

• First Submitted: January 5, 2009
• First Submitted That Met QC Criteria: January 7, 2009
• First Posted (ESTIMATE): January 8, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): January 29, 2013
• Last Update Submitted That Met QC Criteria: January 27, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Female; Contraceptives,; Oral Hormonal;; Contraceptive Methods
• Other Study ID Numbers: 91619; 311041 (OTHER: company internal)