US Cycle Control and Blood Pressure Study



Status:Completed
Conditions:Contraception, Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 45
Updated:4/21/2016
Start Date:June 2009
End Date:September 2010

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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

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
We found this trial at
28
sites
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Chandler, AZ
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Anaheim, CA
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Atlanta, GA
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Cincinnati, OH
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Clearwater, FL
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Columbia, SC
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Daytona Beach, FL
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Decatur, GA
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Glendale, AZ
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Kalamazoo, MI
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La Crosse, WI
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Lake Worth, FL
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Las Vegas, NV
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Leesburg, FL
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Metairie, LA
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Miami, FL
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New Brunswick, New Jersey 08901
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New Brunswick, NJ
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Philadelphia, PA
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Phoenix, AZ
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Pittsburgh, PA
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Renton, WA
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Richmond, VA
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San Diego, CA
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Seattle, WA
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St. Louis, MO
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Tucson, AZ
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Wexford, PA
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Winston-Salem, NC
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