Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles
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
2 other identifiers
interventional
1,502
1 country
63
Brief Summary
This study is examining a birth control patch for 13 cycles (1 year).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2009
63 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
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2010
CompletedApril 8, 2021
April 1, 2021
1.6 years
May 29, 2009
April 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of pregnancy (yes/no) while on treatment
13 treatment cycles each consisting of 28 days and follow-up period of 14 days
Secondary Outcomes (4)
Vital signs
13 treatment cycles each consisting of 28 days
Physical and gynecological examinations
13 treatment cycles each consisting of 28 days
Laboratory assessments
13 treatment cycles each consisting of 28 days
Adverse events (AE monitoring)
13 treatment cycles each consisting of 28 days
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
55 mg ethinyl estradiol \& 2.1 mg gestodene, 21 days for 13 cycles
Eligibility Criteria
You may qualify if:
- Requiring contraception
- Normal cervical smear
- Maximum age for smokers is 35
- History of regular cyclic menstrual periods
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (63)
Unknown Facility
Birmingham, Alabama, 35235, United States
Unknown Facility
Glendale, Arizona, 85304, United States
Precision Trials
Phoenix, Arizona, 85032, United States
Visions Clinical Research - Tucson
Tucson, Arizona, 85712, United States
Unknown Facility
Carmichael, California, 95608, United States
Unknown Facility
Pacific Palisades, California, 90272, United States
Unknown Facility
Paramount, California, 90723, United States
Genesis Center for Clinical Research
San Diego, California, 92103, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Santa Ana, California, 92705, United States
Unknown Facility
Torrance, California, 90502, United States
Unknown Facility
Denver, Colorado, 80218, United States
Unknown Facility
Littleton, Colorado, 80122, United States
Unknown Facility
New London, Connecticut, 06320, United States
Visions Clinical Research
Boynton Beach, Florida, 33472-2952, United States
Unknown Facility
Jacksonville, Florida, 32207, United States
Unknown Facility
Miami, Florida, 33186, United States
Unknown Facility
Pembroke Pines, Florida, 33024, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Unknown Facility
Atlanta, Georgia, 30328, United States
Unknown Facility
Decatur, Georgia, 30034, United States
Unknown Facility
Roswell, Georgia, 30075, United States
Research Associates
Boise, Idaho, 83702, United States
Rosemark Women Care Specialist
Idaho Falls, Idaho, 83404, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Newburgh, Indiana, 47630, United States
Unknown Facility
South Bend, Indiana, 46601, United States
Unknown Facility
Marrero, Louisiana, 70072, United States
Unknown Facility
Boston, Massachusetts, 02118, United States
Unknown Facility
Chaska, Minnesota, 55318, United States
Unknown Facility
Lincoln, Nebraska, 68510, United States
Unknown Facility
Las Vegas, Nevada, 89030, United States
Unknown Facility
Las Vegas, Nevada, 89106, United States
Office of Dr. R. Garn Mabey, MD
Las Vegas, Nevada, 89128, United States
Unknown Facility
Lawrenceville, New Jersey, 08648, United States
Unknown Facility
Moorestown, New Jersey, 08057, United States
Unknown Facility
Albuquerque, New Mexico, 87102, United States
Unknown Facility
New York, New York, 10032, United States
Unknown Facility
New Bern, North Carolina, 28562, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Cincinnati, Ohio, 45267-0457, United States
Unknown Facility
Cleveland, Ohio, 44122, United States
Unknown Facility
Columbus, Ohio, 43213, United States
York Clinical Consulting
Oklahoma City, Oklahoma, 73120, United States
Unknown Facility
Eugene, Oregon, 97401, United States
Unknown Facility
Portland, Oregon, 97239-3011, United States
Unknown Facility
Philadelphia, Pennsylvania, 19114, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213, United States
Unknown Facility
Warwick, Rhode Island, 02886, United States
Unknown Facility
Columbia, South Carolina, 29201, United States
Unknown Facility
Mt. Pleasant, South Carolina, 29464, United States
Unknown Facility
Chattanooga, Tennessee, 37404, United States
Unknown Facility
Knoxville, Tennessee, 37920, United States
Women's Care Center, PLC
Memphis, Tennessee, 38119, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Nashville, Tennessee, 37205, United States
Unknown Facility
Corpus Christi, Texas, 78414, United States
Practice Research Organization
Dallas, Texas, 75230, United States
Advances in Health, inc.
Houston, Texas, 77030, United States
The Woman's Hospital of Texas
Houston, Texas, 77054, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Women's Clinical Research Center
Seattle, Washington, 98105, United States
Related Links
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2009
First Posted
June 1, 2009
Study Start
May 1, 2009
Primary Completion
December 13, 2010
Study Completion
December 13, 2010
Last Updated
April 8, 2021
Record last verified: 2021-04