Female Contraception Clinical Trial
Official title:
A Definitive Bioequivalence Study of ORTHO EVRA Exhibiting Faster Equilibration Profile and Currently Marketed ORTHO EVRA in Healthy Female Volunteers
The purpose of this single center, randomized, double-blind, 2 way crossover study was to determine the bioequivalence of a norelgestromin/ethinyl estradiol (NGMN/EE) transdermal contraceptive system.
Status | Completed |
Enrollment | 42 |
Est. completion date | August 2004 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Healthy as determined by physical and gynecologic examinations, clinical laboratory assessments, vital sign measurements, and a 12-lead electrocardiogram (ECG) Exclusion Criteria: - Pregnant - Lactating - Currently using hormonal contraceptive |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The faster equilibrating patches were bioequivalent to the currently marketed patch | |||
Secondary | Safe and well tolerated |
Status | Clinical Trial | Phase | |
---|---|---|---|
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