Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers
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
2 other identifiers
interventional
453
4 countries
17
Brief Summary
The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2004
Shorter than P25 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 18, 2008
CompletedFirst Posted
Study publicly available on registry
February 26, 2008
CompletedDecember 31, 2014
December 1, 2014
February 18, 2008
December 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cycle control and bleeding pattern
7 cycles
Secondary Outcomes (6)
Pearl index
7 cycles
Laboratory tests
Screening
Adverse Events
7 cycles
General Physical and gynecological examinations
Screening
Vital signs
Screening, admission
- +1 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy female volunteer aged 18-35,
- Smokers 18-30
You may not qualify if:
- Contraindications for using hormonal contraceptives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (17)
Unknown Facility
Horn, 3580, Austria
Unknown Facility
Leibnitz, Styria, 8430, Austria
Unknown Facility
Mödling, 2340, Austria
Unknown Facility
Sankt Pölten, 3100, Austria
Unknown Facility
Vienna, 1050, Austria
Unknown Facility
Wörgl, 6300, Austria
Unknown Facility
Pärnu, 80010, Estonia
Unknown Facility
Talinn, 10145, Estonia
Unknown Facility
Tartu, 51003, Estonia
Unknown Facility
Helsinki, 00100, Finland
Unknown Facility
Helsinki, 00260, Finland
Unknown Facility
Tampere, 33200, Finland
Unknown Facility
Turku, 20101, Finland
Unknown Facility
Kaunas, 3042, Lithuania
Unknown Facility
Kaunas, 3043, Lithuania
Unknown Facility
Vilnius, 01118, Lithuania
Unknown Facility
Vilnius, 2035, Lithuania
Related Publications (2)
Anttila L, Neunteufel W, Petraglia F, Marr J, Kunz M. Cycle control and bleeding pattern of a 24/4 regimen of drospirenone 3 mg/ethinylestradiol 20 mug compared with a 21/7 regimen of desogestrel 150 mug/ethinylestradiol 20 mug: a pooled analysis. Clin Drug Investig. 2011;31(8):519-525. doi: 10.2165/11590260-000000000-00000.
PMID: 21721590RESULTAnttila L, Bachmann G, Hernadi L, Kunz M, Marr J, Klipping C. Contraceptive efficacy of a combined oral contraceptive containing ethinyloestradiol 20 mug/drospirenone 3mg administered in a 24/4 regimen: a pooled analysis of four open-label studies. Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):180-2. doi: 10.1016/j.ejogrb.2010.12.037. Epub 2011 Feb 1.
PMID: 21277674RESULT
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2008
First Posted
February 26, 2008
Study Start
March 1, 2004
Study Completion
June 1, 2005
Last Updated
December 31, 2014
Record last verified: 2014-12