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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185419
First received: September 13, 2005
Last updated: January 13, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Contraception
Drug: Yasmin
Drug: Marvelon
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight changes [ Time Frame: 13 treatment cycles ] [ Designated as safety issue: No ]
  • Contraceptive reliability [ Time Frame: 13 treatment cycles ] [ Designated as safety issue: No ]
  • Effects on skin condition [ Time Frame: 13 treatment cycles ] [ Designated as safety issue: No ]
  • Changes in MDQ subscale scores [ Time Frame: 13 treatment cycles ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: the whole study period ] [ Designated as safety issue: Yes ]

Enrollment: 842
Study Start Date: November 2003
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: Yasmin
30 µg ethinylestradiol, 3mg drospirenone
Active Comparator: Arm 2 Drug: Marvelon
30 µg ethinylestradiol, 150 µg desogestrel

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.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Chinese female requesting contraceptives

Exclusion Criteria:

  • Vascular, metabolic, hepatic, renal, oncologic and other diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185419

Locations
China
ask Contact, China
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00185419     History of Changes
Other Study ID Numbers: 91330, 308062
Study First Received: September 13, 2005
Last Updated: January 13, 2009
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014