Bioequivalence Study of Patches With Different Equilibration Profiles

June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The faster equilibrating patches were bioequivalent to the currently marketed patch

Secondary Outcome Measures

Outcome Measure
Safe and well tolerated

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

October 16, 2008

First Posted (Estimate)

October 17, 2008

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Female Contraception

Clinical Trials on norelgestromin/ethinyl estradiol (NGMN/EE) transdermal contraceptive system.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe