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Bioequivalence Study of Patches With Different Equilibration Profiles

Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Female Contraception

Intervention: norelgestromin/ethinyl estradiol (NGMN/EE) transdermal contraceptive system. (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


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.

Clinical Details

Official title: A Definitive Bioequivalence Study of ORTHO EVRA Exhibiting Faster Equilibration Profile and Currently Marketed ORTHO EVRA in Healthy Female Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Health Services Research

Primary outcome: The faster equilibrating patches were bioequivalent to the currently marketed patch

Secondary outcome: Safe and well tolerated

Detailed description: 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 with a body mass index (BMI) between 16 and 29. 9 kg/m2, and a hematocrit of at least 36%. Eligible patients were randomly assigned to 1 of 2 treatment sequence groups. A 20 cm2 NGMN/EE transdermal contraceptive patch (test or NORELGESTROMIN/ETHINYL ESTRADIOL (reference) was applied to each patient on the buttock and worn for 7 days. Twenty-one days after removal of the first patch the patient crossed over to the other treatment. After each patch was removed, the skin was checked for redness and swelling. Blood samples were collected for measurement of drug concentrations during the 7-day wear periods and for 3 days after each patch was removed. Patients were telephoned weekly during the washout period to remind them to use back-up contraception. After the last blood sample collection in Period 2, or in instances where the patient withdrew early from the study, posttreatment procedures including physical and gynecologic examinations, vital signs, laboratory evaluations, and a serum pregnancy test were performed. The following pharmacokinetic parameters were to be estimated for NGMN, NG, and EE after test and

NORELGESTROMIN/ETHINYL ESTRADIOL patch application: Cmax - maximum observed serum

concentration after patch application; tmax - time of maximum serum concentration after

patch application; Css - mean steady-state concentration for NGMN and EE after patch

application calculated as the mean concentration between 48 and 168 hours; Cavg - average

concentration for NG calculated as AUC168/168; AUC - the area under the serum

concentration-time curve for NGMN, NG, and EE using linear trapezoidal summation from the data obtained after patch application from time 0 (dosing) to 168 hours postdose (AUC168), from time 0 to 240 hours postdose (AUC240), from time 0 to infinity (AUCinf), and from time

0 to the last measurable concentration for EE (AUClast); and t½ - apparent terminal

half-life, computed as (ln2/ke) where ke is the slope of the terminal log-linear phase of the serum concentration-time curve. Patch adhesion was assessed and scores summarized. Assessment of bioequivalence will be based on the use of 90% confidence intervals (for 2 one-sided test procedures) for the ratios of mean (test to reference) pharmacokinetic parameters, AUC240 and Css for NGMN and EE. The 2 patches were considered bioequivalent if the 90% confidence intervals fell within 80% to 125% limits for both AUC240 and Css for NGMN and EE. Safety evaluations were based on adverse events, including erythema and application site reaction and changes in physical and gynecologic examinations (including breast exams), vital signs, 12-lead ECGs, and clinical laboratory test results from pre- to poststudy. Serum pregnancy testing and urine drug screening was performed. Changes from screening were summarized using descriptive statistics. A fast equilibratin patch or NORELGESTROMIN/ETHINYL ESTRADIOL patch (20 cm2 transdermal contraceptive system) contains NGMN 6. 0 mg and EE 0. 75 mg. Each patient wore a patch (test or NORELGESTROMIN/ETHINYL ESTRADIOL) on the buttock for 7 days, according to a computer-generated randomization schedule. There was a 21-day washout period. Patients then crossed over to the other treatment for 7 days.


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.


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

Locations and Contacts

Additional Information

Bioequivalence study of patches with different equilibration profiles

Starting date: May 2004
Last updated: June 6, 2011

Page last updated: August 23, 2015

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