YAZ, Oral Contraceptive Registration in China | NCT00819312

Studies
YAZ, Oral Contraceptive Registration in China

NCT00819312

Sponsor

Bayer

Status

Completed

Last Update Posted

Jan 29, 2013Estimated

Enrollment

675Actual

Phase

Phase 3

Conditions

Contraception

Interventions

YAZ (SH T00186, BAY86-5300)

Countries

China
Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
311041	Other Identifier	company internal

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Jan 5, 2009

First Submission Date that Met QC Criteria

Jan 7, 2009

First Posted Date

Jan 8, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2013

Last Update Posted Date

Jan 29, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

675Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Active Comparator		Drug: YAZ (SH T00186, BAY86-5300)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
YAZ (SH T00186, BAY86-5300)	Drug	20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	Time Frame
Bleeding pattern indices		13 cycles
Cycle control parameters		13 cycles
Adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Intervention Browse Module

MeSH Terms

ID	Term
C534342	drospirenone and ethinyl estradiol combination

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Guangzhou	Guangdong	510120	China