Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu
Trial record 24 of 27 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND bleeding

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

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

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

Layout table for study information
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 ]

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.

Layout table for eligibility information
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

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 identifier (NCT number): NCT00624130

Layout table for location information
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
Layout table for investigator information
Study Director: Bayer Study Director Bayer

Publications of Results:
Layout table for additonal information
Responsible Party: Bayer Identifier: NCT00624130    
Other Study ID Numbers: 91352
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Cycle control,
Bleeding pattern
Additional relevant MeSH terms:
Layout table for 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