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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00185419
• Collaborator: (none)
• Enrollment: 842
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 30.1

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: Yasmin; Drug: Marvelon	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 842 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Study Start Date: Nov 1, 2003
• Actual Primary Completion Date: Mar 1, 2006
• Actual Study Completion Date: Mar 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1	Drug: Yasmin; 30 µg ethinylestradiol, 3mg drospirenone
Active Comparator: Arm 2	Drug: Marvelon; 30 µg ethinylestradiol, 150 µg desogestrel

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Weight changes [13 treatment cycles]

2. Contraceptive reliability [13 treatment cycles]

3. Effects on skin condition [13 treatment cycles]

4. Changes in MDQ subscale scores [13 treatment cycles]

5. Adverse Events [the whole study period]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy Chinese female requesting contraceptives

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		ask Contact		China

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00185419
• Other Study ID Numbers: 91330; 308062
• First Posted: Sep 16, 2005
• Last Update Posted: Jan 14, 2009
• Last Verified: Jan 1, 2009

• Additional relevant MeSH terms: Desogestrel

Study Results

No Results Posted as of Jan 14, 2009