ClinConnect ClinConnect Logo
Search / Trial NCT00697307

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 06, 2025

Completed

Keywords

Bioequivalence Contraception Contraceptive Patch Ortho Evra Norelgestromin Ngmn Ethinyl Estradiol Ee

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.

Locations

Patients applied

0 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

Similar Trials