US Cycle Control and Blood Pressure Study
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
1 other identifier
interventional
346
1 country
28
Brief Summary
Birth Control Patch Study
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 Jun 2009
Shorter than P25 for phase_3
28 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
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 15, 2009
CompletedFirst Posted
Study publicly available on registry
June 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedOctober 9, 2015
January 1, 2014
1.2 years
June 15, 2009
September 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cycle control parameters and bleeding pattern indices
Treatment cycles 2-7
Secondary Outcomes (2)
Number of pregnancies while on treatment up to 14 days after removal of the last patch
7 treatment cycles each consisting of 28 days and follow-up period of 14 days
Evaluation of blood pressure changes during the dosing-free interval
7 treatment cycles each consisting of 28 days
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORInterventions
21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 7 cycles and placebo tablets matching the conditions of the treatment of Arm 2
21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 7 cycles and placebo patches matching the conditions of the treatment of Arm 1
Eligibility Criteria
You may qualify if:
- 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
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 (28)
Unknown Facility
Chandler, Arizona, 85225-2909, United States
Unknown Facility
Glendale, Arizona, 85304, United States
Unknown Facility
Phoenix, Arizona, 85032, United States
Unknown Facility
Tucson, Arizona, 85712, United States
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
San Diego, California, 92121, United States
Unknown Facility
Clearwater, Florida, 33759, United States
Unknown Facility
Daytona Beach, Florida, 32114, United States
Unknown Facility
Lake Worth, Florida, 33461, United States
Unknown Facility
Leesburg, Florida, 34748, United States
Unknown Facility
Miami, Florida, 33169, United States
Unknown Facility
Atlanta, Georgia, 30342, United States
Unknown Facility
Decatur, Georgia, 30034, United States
Unknown Facility
Metairie, Louisiana, 70006, United States
Unknown Facility
Kalamazoo, Michigan, 49009, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
Las Vegas, Nevada, 89104, United States
Unknown Facility
New Brunswick, New Jersey, 08901, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Cincinnati, Ohio, 45246, United States
Unknown Facility
Philadelphia, Pennsylvania, 19114, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15206, United States
Unknown Facility
Wexford, Pennsylvania, 15090, United States
Unknown Facility
Columbia, South Carolina, 29201, United States
Unknown Facility
Richmond, Virginia, 23294, United States
Unknown Facility
Renton, Washington, 98055, United States
Unknown Facility
Seattle, Washington, 98105, United States
Unknown Facility
La Crosse, Wisconsin, 54691, United States
Related Publications (1)
Merz M, Kroll R, Lynen R, Bangerter K. Bleeding pattern and cycle control of a low-dose transdermal contraceptive patch compared with a combined oral contraceptive: a randomized study. Contraception. 2015 Feb;91(2):113-20. doi: 10.1016/j.contraception.2014.10.004. Epub 2014 Oct 13.
PMID: 25453585DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2009
First Posted
June 16, 2009
Study Start
June 1, 2009
Primary Completion
August 1, 2010
Study Completion
September 1, 2010
Last Updated
October 9, 2015
Record last verified: 2014-01