A Study to Evaluate the Hormone Exposure From Multiple Commercial Lots of ORTHO EVRA (a Transdermal Contraceptive Patch)
The objective of this study is to estimate the exposure to the hormones norelgestromin, norgestrel, and ethinyl estradiol in the bloodstream of healthy female volunteers across multiple commercial lots of ORTHO EVRAÂ® (a transdermal contraceptive patch) and to compare these data to historical hormonal exposure data from one ORTHO EVRAÂ® clinical development lot.
Drug: EVRA transdermal contraceptive patch 6 mg NGMN and 0.75 mg EE
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label, Randomized, Partially Balanced, Incomplete Block Design Sudy to Evaluate the Hormone Exposure From Commercial ORTHO EVRA�|
- A comparison of the exposure and pharmacokinetics of NGMN, NG, and EE after a single patch application of different commercial lots of ORTHO EVRA and a comparison of these data to historical hormonal data from a clinical development patch.
- An assessment of safety from screening to final visit (incidence of adverse events, changes in physical, gynecologic and breast examinations, vital signs, laboratory tests and electrocardiogram results).
|Study Start Date:||April 2004|
|Study Completion Date:||September 2004|
EVRA transdermal contraceptive patch 6 mg NGMN and 0.75 mg EE
|Drug: EVRA transdermal contraceptive patch 6 mg NGMN and 0.75 mg EE|
This multicenter, open-label, randomized, partially-balanced, incomplete block design study will consist of a pre-treatment phase (a screening period lasting up to 21 days), an open-label treatment phase (three 7-day treatment periods separated by 21-day washouts), and a post-treatment phase (a follow-up or early withdrawal visit). Total participation in the study is approximately 67 days. Approximately 52 subjects will be enrolled. The study population comprises healthy women, ages 18 to 45 years inclusive, who weigh at least 110 pounds, have a body mass index (BMI) between 16 and 29.9 kg per meter squared.
An ORTHO EVRA® patch from 1 of the 13 selected commercial lots will be applied to the buttock of each subject and worn for 7 days. Patches will be applied on Days 1, 29, and 57 by the investigator or designated study unit personnel. Each patch will be worn on the upper outer quadrant of the same buttock, but the 3 patches will not necessarily be placed in the exact same position. The investigator or designated study unit personnel will remove the patches on Days 8, 36, and 64 and will evaluate the adhesion of the patches before removal.
Subjects will be confined to the study unit for blood sample collections for determination of NGMN, NG, and EE serum concentrations. Blood samples will be collected (via venipuncture) immediately before and at specified time points after each patch application. Pharmacokinetic parameters of NGMN, NG, and EE, including Cmax, tmax, and AUC for each treatment will be estimated by standard methods. Safety will be assessed throughout the study, and will be based on adverse events and changes in physical and gynecologic examinations (including breast examinations), vital signs, electrocardiograms (ECGs), and clinical laboratory test results. Three 7-day treatment periods, separated by 21-day washouts, as follows: Each ORTHO EVRA® patch will be worn on the buttock (upper outer quadrant) for 7 days. Twenty one days after completing each treatment, subjects will cross over to the next treatment for 7 days. The patch will be applied to the upper outer quadrant of the same buttock as before, but not necessarily in the exact same spot.
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|