Status:
COMPLETED
Bioequivalence Study of Patches With Different Release Profiles
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Female Contraception
Eligibility:
FEMALE
18-45 years
Brief Summary
The purpose of this study was to determine the bioequivalence of a norelgestromin/ethinyl estradiol (NGMN/EE) transdermal contraceptive system.
Detailed Description
The primary objective was to determine the bioequivalence of a norelgestromin/ethinyl estradiol (NGMN/EE) transdermal contraceptive system lot with a cumulative release profile below the lower limit o...
Eligibility Criteria
Inclusion
- Healthy as determined by physical and gynecologic examinations, clinical laboratory assessments, vital sign measurements, and a 12-lead electrocardiogram (ECG)
Exclusion
- Pregnant
- Lactating
- Currently using hormonal contraceptive
Key Trial Info
Start Date :
March 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2003
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00697307
Start Date
March 1 2003
End Date
July 1 2003
Last Update
June 8 2011
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