Status:
COMPLETED
US Cycle Control and Blood Pressure Study
Lead Sponsor:
Bayer
Conditions:
Contraception
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
Birth Control Patch Study
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT00920985
Start Date
June 1 2009
End Date
September 1 2010
Last Update
October 9 2015
Active Locations (28)
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1
Chandler, Arizona, United States, 85225-2909
2
Glendale, Arizona, United States, 85304
3
Phoenix, Arizona, United States, 85032
4
Tucson, Arizona, United States, 85712