A Clinical Study on Yasmin® vs. Marvelon® in Chinese Wome... | NCT00185419

Studies
A Clinical Study on Yasmin® vs. Marvelon® in Chinese Women Requiring Contraception

NCT00185419

Sponsor

Bayer

Status

Completed

Last Update Posted

Jan 14, 2009Estimated

Enrollment

842Actual

Phase

Phase 3

Conditions

Contraception

Interventions

Yasmin
Marvelon

Countries

China

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
308062

Status Module

Record Verification Date

Jan 2009

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

Nov 2003

Primary Completion Date

Mar 2006Actual

Completion Date

Mar 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

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 13, 2009

Last Update Posted Date

Jan 14, 2009Estimated

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 Yasmin and Marvelon on cycle control in healthy Chinese women

Detailed Description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

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

842Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Active Comparator		Drug: Yasmin
Arm 2	Active Comparator		Drug: Marvelon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Yasmin	Drug	30 µg ethinylestradiol, 3mg drospirenone	Arm 1
Marvelon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary efficacy variable is the comparison of cycle control from randomisation to cycle 13. This will be based on the number of subjects reporting at least 1 unexpected intracyclic bleeding episode between cycles 2 to 13.		13 treatment cycles (1 cycle= 28 days)

Secondary Outcomes

Measure	Description	Time Frame
Weight changes		13 treatment cycles
Contraceptive reliability		13 treatment cycles
Effects on skin condition

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy Chinese female requesting contraceptives

Exclusion Criteria:

Vascular, metabolic, hepatic, renal, oncologic and other diseases

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 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
D017135	Desogestrel

Ancestor Terms

ID	Term
D009652	Norpregnenes
D009650	Norpregnanes
D009654	Norsteroids
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided