Trial Condition(s):
Contraception
Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles
Bayer Identifier:
91555
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
This study is examining a birth control patch for 13 cycles (1 year).
Inclusion Criteria
- Requiring contraception - Normal cervical smear - Maximum age for smokers is 35 - 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 Investigative Site Chattanooga, United States, 37404 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19114 | 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 Rosemark Women Care Specialist Idaho Falls, United States, 83404 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Visions Clinical Research Boynton Beach, United States, 33472-2952 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site South Bend, United States, 46601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02118 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Genesis Center for Clinical Research San Diego, United States, 92103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Corpus Christi, United States, 78414 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Diego, United States, 92108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Albuquerque, United States, 87102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miami, United States, 33186 | 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 Investigative Site Portland, United States, 97239-3011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jacksonville, United States, 32207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mt. Pleasant, United States, 29464 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Decatur, United States, 30034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Bern, United States, 28562 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Diego, United States, 92123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newburgh, United States, 47630 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moorestown, United States, 08057 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. R. Garn Mabey, MD Las Vegas, United States, 89128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chaska, United States, 55318 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Marrero, United States, 70072 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbia, United States, 29201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Las Vegas, United States, 89106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Glendale, United States, 85304 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roswell, United States, 30075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Denver, United States, 80218 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New York, United States, 10032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Care Center, PLC Memphis, United States, 38119 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lincoln, United States, 68510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Research Associates Boise, United States, 83702 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Carmichael, United States, 95608 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Knoxville, United States, 37920 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Las Vegas, United States, 89030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Clinical Research Center Seattle, United States, 98105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torrance, United States, 90502 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chicago, United States, 60612 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pacific Palisades, United States, 90272 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lawrenceville, United States, 08648 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Paramount, United States, 90723 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Littleton, United States, 80122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cleveland, United States, 44122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warwick, United States, 02886 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nashville, United States, 37203 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United States, 35235 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Meridien Research St. Petersburg, United States, 33709 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pittsburgh, United States, 15213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Atlanta, United States, 30328 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Eugene, United States, 97401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Woman's Hospital of Texas Houston, United States, 77054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cincinnati, United States, 45267-0457 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Norfolk, United States, 23507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nashville, United States, 37205 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advances in Health, inc. Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pembroke Pines, United States, 33024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santa Ana, United States, 92705 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New London, United States, 06320 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Practice Research Organization Dallas, United States, 75230 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations York Clinical Consulting Oklahoma City, United States, 73120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Multicenter, open-label, uncontrolled study to investigate the efficacy and safety of the transdermal contraceptive patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene in a 21-day regimen for 13 cycles in 1650 healthy female subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Occurrence of pregnancy (yes/no) while on treatmentTimeframe: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days
Secondary Outcome
- Vital signsTimeframe: 13 treatment cycles each consisting of 28 days
- Physical and gynecological examinationsTimeframe: 13 treatment cycles each consisting of 28 days
- Laboratory assessmentsTimeframe: 13 treatment cycles each consisting of 28 days
- Adverse events (AE monitoring)Timeframe: 13 treatment cycles each consisting of 28 days
Additional Information
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