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

Contraception Clinical Trial

Official title:

An 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185419
• Other study ID #: 91330
• Secondary ID: 308062
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: January 13, 2009
• Start date: November 2003
• Est. completion date: March 2006

Study information

• Verified date: January 2009
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 842
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy Chinese female requesting contraceptives

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Yasmin
30 µg ethinylestradiol, 3mg drospirenone
• Marvelon
30 µg ethinylestradiol, 150 µg desogestrel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Weight changes		13 treatment cycles	No
Secondary	Contraceptive reliability		13 treatment cycles	No
Secondary	Effects on skin condition		13 treatment cycles	No
Secondary	Changes in MDQ subscale scores		13 treatment cycles	No
Secondary	Adverse Events		the whole study period	Yes

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