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A Study to Evaluate Bioequivalence and Adhesion of a Transdermal Contraceptive Patch Manufactured With Newly Sourced Adhesive Components and Currently Marketed EVRA in Healthy Adult Women

NCT03274297 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-02-03

No results posted yet for this study

Summary

The purpose of this study is to determine the bioequivalence of the hormones (ie, norelgestromin \[NGMN\] and ethinyl estradiol \[EE\]) from the transdermal contraceptive patch and to evaluate the adhesion of the transdermal contraceptive patch using the newly sourced adhesive component, as compared to the currently marketed EVRA patch.

Conditions

  • Healthy

Interventions

DRUG

EVRA patch (NGMN+EE) (Treatment A) (Reference)

A single transdermal contraceptive patch of EVRA (NGMN + EE) containing 6 milligram (mg) of the progestin NGMN and 600 microgram (mcg) of the EE will be applied to the buttock (right or left) of participants on Day 1 of each treatment period and is removed 7 days after patch application, ie, on Day 8.

DRUG

HMW PIB patch (NGMN+EE) (Treatment B) (Test)

A single transdermal contraceptive HMW PIB (NGMN + EE) patch containing 6 mg of the progestin NGMN and 600 mcg of the EE will be applied to the buttock (right or left) of participants on Day 1 of each treatment period and is removed 7 days after patch application, ie, on Day 8.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-20
Primary Completion
2018-05-07
Completion
2018-05-07

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03274297 on ClinicalTrials.gov