check_circleStudy Completed

Contraception

Bayer Identifier:

91556

ClinicalTrials.gov Identifier:

NCT00920985

EudraCT Number:

Not Available

EU CT Number:

Not Available
US Cycle Control and Blood Pressure Study

Trial purpose

Birth Control Patch Study

Key Participants Requirements

Sex

Female

Age

18 - 45 Years
  • - Female subject requesting contraception
    - Age: 18 - 45 years (inclusive); smokers must not be older than 35 years at the time of informed consent
    - Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
    - History of regular cyclic menstrual periods
  • - Pregnancy or lactation
    - Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
    - Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
    - Use of other contraceptive methods than study medication

Trial summary

Enrollment Goal
346
Trial Dates
June 2009 - September 2010
Phase
Phase 3
Could I Receive a placebo
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Clinical Trials Management, LLCMetairie, 70006, United States
Completed
University of Wisconsin - La CrosseLa Crosse, 54691, United States
Completed
Clinical Trials Research Services, LLCPittsburgh, 15206, United States
Completed
Elite Research InstituteMiami, 33169, United States
Completed
Advanced Clinical Research InstituteAnaheim, 92801, United States
Completed
Altus ResearchLake Worth, 33461, United States
Completed
Soapstone Center for Clinical ResearchDecatur, 30034, United States
Completed
Precision Trials, LLCGlendale, 85304, United States
Completed
Clinical Research Center of NevadaLas Vegas, 89104, United States
Completed
Lyndhurst Gynecologic AssociatesWinston-Salem, 27103, United States
Completed
Clinical Research of Philadelphia, LLCPhiladelphia, 19114, United States
Completed
Associates in OB-GYN, Inc.Cincinnati, 45246, United States
Completed
Atlantic Institute of Clinical ResearchDaytona Beach, 32114, United States
Completed
Women's Medical Research Group, LLCClearwater, 33759, United States
Completed
Robert Wood Johnson Medical SchoolNew Brunswick, 08901, United States
Completed
National Clinical Research, Inc.Richmond, 23294, United States
Completed
Beyer ResearchKalamazoo, 49009, United States
Completed
Dr. Susan Floyd, MDWexford, 15090, United States
Completed
New Ballas OB-GYN, Inc.St. Louis, 63141, United States
Completed
Visions Clinical Research - TucsonTucson, 85712, United States
Completed
Seattle Women's: Health, Research, GynecologySeattle, 98105, United States
Completed
Office of Dr. Alfred Moffett, MDLeesburg, 34748, United States
Completed
South Carolina Clinical Research CenterColumbia, 29201, United States
Completed
Valley Women's ClinicRenton, 98055, United States
Completed
Star_W Research CenterChandler, 85225-2909, United States
Completed
Precision TrialsPhoenix, 85032, United States
Completed
IGO Medical Group, AMCSan Diego, 92121, United States
Completed
Altanta Women's Research Institute, Inc.Atlanta, 30342, United States

Primary Outcome

  • Cycle control parameters and bleeding pattern indices
    date_rangeTime Frame:
    Treatment cycles 2-7
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Number of pregnancies while on treatment up to 14 days after removal of the last patch
    date_rangeTime Frame:
    7 treatment cycles each consisting of 28 days and follow-up period of 14 days
    enhanced_encryption
    Safety Issue:
    no
  • Evaluation of blood pressure changes during the dosing-free interval
    date_rangeTime Frame:
    7 treatment cycles each consisting of 28 days
    enhanced_encryption
    Safety Issue:
    no

Trial design

Multi-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group Study to Evaluate Cycle Control, Bleeding Pattern, Blood Pressure, Lipid and Carbohydrate Metabolism of the Transdermal Contraceptive Patch (Material no. 80876395 / 2.1 mg Gestodene and 0.55 mg Ethinylestradiol) versus an Oral Comparator Containing 20 µg Ethinylestradiol and 100 µg Levonorgestrel in a 21-day Regimen for 7 Cycles in 400 Women
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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