Trial Condition(s):
Contraception
US Cycle Control and Blood Pressure Study
Bayer Identifier:
91556
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Birth Control Patch Study
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Clinical Trials Management, LLC Metairie, United States, 70006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Wisconsin - La Crosse La Crosse, United States, 54691 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Trials Research Services, LLC Pittsburgh, United States, 15206 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Elite Research Institute Miami, United States, 33169 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advanced Clinical Research Institute Anaheim, United States, 92801 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Altus Research Lake Worth, United States, 33461 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Soapstone Center for Clinical Research Decatur, United States, 30034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Precision Trials, LLC Glendale, United States, 85304 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research Center of Nevada Las Vegas, United States, 89104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lyndhurst Gynecologic Associates Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research of Philadelphia, LLC Philadelphia, United States, 19114 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Associates in OB-GYN, Inc. Cincinnati, United States, 45246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Atlantic Institute of Clinical Research Daytona Beach, United States, 32114 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Medical Research Group, LLC Clearwater, United States, 33759 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Robert Wood Johnson Medical School New Brunswick, United States, 08901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Clinical Research, Inc. Richmond, United States, 23294 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Beyer Research Kalamazoo, United States, 49009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Susan Floyd, MD Wexford, United States, 15090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations New Ballas OB-GYN, Inc. St. Louis, United States, 63141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Visions Clinical Research - Tucson Tucson, United States, 85712 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seattle Women's: Health, Research, Gynecology Seattle, United States, 98105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Alfred Moffett, MD Leesburg, United States, 34748 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Carolina Clinical Research Center Columbia, United States, 29201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Valley Women's Clinic Renton, United States, 98055 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Star_W Research Center Chandler, United States, 85225-2909 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Precision Trials Phoenix, United States, 85032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IGO Medical Group, AMC San Diego, United States, 92121 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Altanta Women's Research Institute, Inc. Atlanta, United States, 30342 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Cycle control parameters and bleeding pattern indicesTimeframe: Treatment cycles 2-7
Secondary Outcome
- Number of pregnancies while on treatment up to 14 days after removal of the last patchTimeframe: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days
- Evaluation of blood pressure changes during the dosing-free intervalTimeframe: 7 treatment cycles each consisting of 28 days
Additional Information
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