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

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.
ClinicalTrials.gov Identifier: NCT00185419
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : January 14, 2009
Sponsor:
Information provided by:

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  (Clinical Trial)
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 : November 2003
Primary Completion Date : March 2006
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

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

Secondary Outcome Measures :
  1. Weight changes [ Time Frame: 13 treatment cycles ]
  2. Contraceptive reliability [ Time Frame: 13 treatment cycles ]
  3. Effects on skin condition [ Time Frame: 13 treatment cycles ]
  4. Changes in MDQ subscale scores [ Time Frame: 13 treatment cycles ]
  5. Adverse Events [ Time Frame: the whole study period ]

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: September 16, 2005    Key Record Dates
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