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
2104
mi
from 91732
Columbia, SC
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16
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Anaheim, CA
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1919
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Atlanta, GA
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356
mi
from 91732
Chandler, AZ
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1880
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Cincinnati, OH
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2117
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Clearwater, FL
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2187
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Daytona Beach, FL
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1924
mi
from 91732
Decatur, GA
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14
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Glendale, AZ
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1840
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Kalamazoo, MI
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1578
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from 91732
La Crosse, WI
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2308
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from 91732
Lake Worth, FL
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208
mi
from 91732
Las Vegas, NV
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2149
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from 91732
Leesburg, FL
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1648
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Metairie, LA
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2321
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Miami, FL
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New Brunswick, New Jersey 08901
2410
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from 91732
New Brunswick, NJ
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2375
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from 91732
Philadelphia, PA
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343
mi
from 91732
Phoenix, AZ
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2119
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Pittsburgh, PA
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943
mi
from 91732
Renton, WA
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2267
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from 91732
Richmond, VA
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105
mi
from 91732
San Diego, CA
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964
mi
from 91732
Seattle, WA
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1572
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from 91732
St. Louis, MO
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427
mi
from 91732
Tucson, AZ
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2116
mi
from 91732
Wexford, PA
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2126
mi
from 91732
Winston-Salem, NC
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