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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 26, 2008
Last Update Posted: December 31, 2014
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 (Responsible Party):
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
Intervention Model: Parallel Assignment
Masking: None (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:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Cycle control and bleeding pattern [ Time Frame: 7 cycles ]

Secondary Outcome Measures:
  • Pearl index [ Time Frame: 7 cycles ]
  • Laboratory tests [ Time Frame: Screening ]
  • Adverse Events [ Time Frame: 7 cycles ]
  • General Physical and gynecological examinations [ Time Frame: Screening ]
  • Vital signs [ Time Frame: Screening, admission ]
  • Body weight [ Time Frame: Screening, admission ]

Enrollment: 453
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)


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:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications for using hormonal contraceptives
  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): NCT00624130

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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00624130     History of Changes
Other Study ID Numbers: 91352
First Submitted: February 18, 2008
First Posted: February 26, 2008
Last Update Posted: December 31, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Cycle control,
Bleeding pattern

Additional relevant MeSH terms:
Drospirenone and ethinyl estradiol combination
Reproductive Control Agents
Physiological Effects of Drugs
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action