YAZ, Oral Contraceptive Registration in China

NCT ID: NCT00819312

Last Updated: 2013-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

675 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contraception

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Group Type ACTIVE_COMPARATOR

YAZ (SH T00186, BAY86-5300)

Intervention Type DRUG

20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

YAZ (SH T00186, BAY86-5300)

20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bayer Healthcare AG

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Guangzhou, Guangdong, China

Site Status

Guangzhou, Guangdong, China

Site Status

Wuhan, Hubei, China

Site Status

Nanjing, Jiangsu, China

Site Status

Nanjing, Jiangsu, China

Site Status

Yangzhou, Jiangsu, China

Site Status

Shenyang, Liaoning, China

Site Status

Jinan, Shandong, China

Site Status

Xi’an, Shanxi, China

Site Status

Chengdu, Sichuan, China

Site Status

Beijing, , China

Site Status

Beijing, , China

Site Status

Chongqing, , China

Site Status

Chongqing, , China

Site Status

Shanghai, , China

Site Status

Shanghai, , China

Site Status

Hong Kong, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China Hong Kong

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

311041

Identifier Type: OTHER

Identifier Source: secondary_id

91619

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.