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 |
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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