We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00185419
First Posted: September 16, 2005
Last Update Posted: January 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  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
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

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) ]

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185419


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

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00185419     History of Changes
Other Study ID Numbers: 91330
308062
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: January 14, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Drospirenone
Ethinyl Estradiol
Desogestrel
Drospirenone and ethinyl estradiol combination
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Estrogens
Hormones
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Progestins