Bioequivalence Study of Patches With Different Release Profiles
Launched by JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT, L.L.C. · Jun 11, 2008
Trial Information
Current as of June 27, 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 cumulative release profile below the lower limit of the specifications (low spec lot) compared with a currently marketed lot of EVRANORELGESTROMIN/ETHINYL ESTRADIOL with a cumulative release profile well within the specifications limits (reference lot), 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...
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 & 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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