Bioequivalence Study of Patches With Different Equilibration Profiles
Launched by JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT, L.L.C. · Oct 16, 2008
Trial Information
Current as of June 06, 2025
Completed
Keywords
ClinConnect Summary
The primary objective was to determine the bioequivalence of a norelgestromin/ethinyl estradiol (NGMN/EE) transdermal contraceptive system lot with a faster equilibration profile compared to currently marketed lot of NORELGESTROMIN/ETHINYL ESTRADIOL, after application to the buttock. This was a single center, randomized, double-blind, 2 way crossover study. The double-blind treatment phase included two 7-day treatment periods separated by a 21-day washout period. Safety was assessed throughout the study. The study population was comprised of healthy women who weighed at least 110 pounds wit...
Gender
FEMALE
Eligibility criteria
- 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
About Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is a leading global biopharmaceutical company dedicated to advancing medical innovation and improving patient outcomes. As a subsidiary of Johnson & Johnson, the organization focuses on the research, development, and commercialization of novel therapeutics across various therapeutic areas, including immunology, oncology, neuroscience, and infectious diseases. With a commitment to scientific excellence and collaboration, the company leverages cutting-edge technologies and a robust pipeline to address unmet medical needs and deliver transformative solutions that enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
Study Director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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