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

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ClinicalTrials.gov Identifier: NCT00624130
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment Phase
Contraception Drug: Yasmin 20 Drug: Mercilon Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 453 participants
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
Study Start Date : March 2004
Actual Study Completion Date : June 2005

Arm Intervention/treatment
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)




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

Secondary Outcome Measures :
  1. Pearl index [ Time Frame: 7 cycles ]
  2. Laboratory tests [ Time Frame: Screening ]
  3. Adverse Events [ Time Frame: 7 cycles ]
  4. General Physical and gynecological examinations [ Time Frame: Screening ]
  5. Vital signs [ Time Frame: Screening, admission ]
  6. Body weight [ Time Frame: Screening, admission ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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

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


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, 3042
Kaunas, Lithuania, 3043
Vilnius, Lithuania, 01118
Vilnius, Lithuania, 2035
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications of Results:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00624130     History of Changes
Other Study ID Numbers: 91352
308020
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014

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

Additional relevant MeSH terms:
Drospirenone and ethinyl estradiol combination
Dacuronium
Pancuronium
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