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Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00624130
First received: February 18, 2008
Last updated: May 28, 2009
Last verified: May 2009
History of Changes
  Purpose

The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator.


Condition Intervention Phase
Contraception
 Drug: Yasmin 20
Drug: Mercilon
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Open, Randomized, Parallel Multi-Center Comparison of Cycle Control and Safety of the Oral Contraceptive Yasmin 20 in a 24-Day Regimen vs. Mercilon for 7 Cycles in 440 Healthy Female Volunteers

Resource links provided by NLM:

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

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Cycle control and bleeding pattern [ Time Frame: 7 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pearl index [ Time Frame: 7 cycles ] [ Designated as safety issue: No ]
  • Laboratory tests [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: 7 cycles ] [ Designated as safety issue: Yes ]
  • General Physical and gynecological examinations [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Screening, admission ] [ Designated as safety issue: Yes ]
  • Body weight [ Time Frame: Screening, admission ] [ Designated as safety issue: Yes ]

Enrollment: 440
Study Start Date: March 2004
Study Completion Date: June 2005
Arms Assigned Interventions
Experimental: Arm 1 Drug: Yasmin 20
Yasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral)
Active Comparator: Arm 2 Drug: Mercilon
Mercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral)

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female volunteer aged 18-35,
  • Smokers 18-30

Exclusion Criteria:

  • Contraindications for using hormonal contraceptives
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624130

Locations
Austria
Horn, Austria, 3580
Leibnitz, Austria, 8430
Moedling, Austria, 2340
St. Poelten, Austria, 3100
Wien, Austria, 1050
Woergl, Austria, 6300
Estonia
Paernu, Estonia, 80010
Talinn, Estonia, 10145
Tartu, Estonia, 51003
Finland
Helsinki, Finland, 00100
Helsinki, Finland, 00260
Tampere, Finland, 33200
Turku, Finland, 20101
Lithuania
Kaunas, Lithuania, 3043
Kaunas, Lithuania, 3042
Vilnius, Lithuania, 2035
Vilnius, Lithuania, 01118
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00624130     History of Changes
Other Study ID Numbers: 91352, 308020
Study First Received: February 18, 2008
Last Updated: May 28, 2009
Health Authority: Finland: Finnish Medicines Agency
Estonia: The State Agency of Medicine
Lithuania: State Medicine Control Agency - Ministry of Health
Austria: Federal Ministry for Health and Women
United States: Institutional Review Board

Keywords provided by Bayer:
Contraception,
Cycle control,
Bleeding pattern

Additional relevant MeSH terms:
Contraceptives, Oral
Drospirenone and ethinyl estradiol combination
Contraceptive Agents, Female
Contraceptive Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013