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

ID: NCT00185419
Status: Completed
Phase: Phase 3
Start Date: November 01, 2003
First Submitted: September 13, 2005
Last Updated: January 13, 2009
Results: N/A
Organization: Bayer
Sponsors & Collaborators: Bayer
Location: China
Conditions: Contraception
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Study Description

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.
Condition or disease Intervention/treatment Phase

Contraception

Drug: Yasmin
Other Names
Drug: Marvelon
Other Names
Phase 3

Tracking Information

First Submitted DateSeptember 13, 2005
Last Update Posted DateJanuary 13, 2009
Start DateNovember 01, 2003
Actual Completion DateMarch 01, 2006
Primary Completion DateMarch 01, 2006
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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. [Time Frame: 13 treatment cycles (1 cycle= 28 days)]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Weight changes [Time Frame: 13 treatment cycles]

  • Contraceptive reliability [Time Frame: 13 treatment cycles]

  • Effects on skin condition [Time Frame: 13 treatment cycles]

  • Changes in MDQ subscale scores [Time Frame: 13 treatment cycles]

  • Adverse Events [Time Frame: the whole study period]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleA Clinical Study on Yasmin® vs. Marvelon® in Chinese Women Requiring Contraception
Official TitleAn Open-Label, Randomised, Parallel-Group Comparison to Investigate the Efficacy of Yasmin® (30 µg Ethinylestradiol, 3mg Drospirenone) and Marvelon® (30 µg Ethinylestradiol, 150 µg Desogestrel) on Cycle Control in Healthy Chinese Women Over 13 Cycles
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.

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
842
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None
Primary Purpose
Prevention
Conditions
Contraception
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Yasmin

30 µg ethinylestradiol, 3mg drospirenone

Other Names
Drug: Marvelon

30 µg ethinylestradiol, 150 µg desogestrel

Other Names
Study Groups/Cohorts
Arm 1

Arm 2

Study Arms
Active Comparator Arm 1
Drug : Yasmin
30 µg ethinylestradiol, 3mg drospirenone

Active Comparator Arm 2
Drug : Marvelon
30 µg ethinylestradiol, 150 µg desogestrel

Arm Intervention/Treatment
Active Comparator Arm 1
Drug : Yasmin
Active Comparator Arm 2
Drug : Marvelon

Recruitment Information

Recruitment Status:Completed
Enrollment842
Completion DateMarch 01, 2006
Eligibility Criteria: Inclusion Criteria:
- Healthy Chinese female requesting contraceptives

Exclusion Criteria:
- Vascular, metabolic, hepatic, renal, oncologic and other diseases
GenderFemale
Age20 Years to 35 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Not Available
Listed Location Countries
China

Administrative Information

NCT Number:NCT00185419
Other Study ID Numbers
91330
308062
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyTherapeutic Area Head,
Study Sponsor
Bayer
Collaborators
Not Available
Investigators
Study Director
Bayer Study Director
Bayer