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A Study of New Transdermal Contraceptive Patch at End of Shelf Life and Currently Marketed EVRA at the Beginning of Shelf Life in Healthy Women

NCT04017195 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-04-27

No results posted yet for this study

Summary

The main objectives of this study are to determine the bioequivalence of the hormones (example, norelgestromin \[NGMN\] and ethinyl estradiol \[EE\]) from the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component, evaluate the adhesion of the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component and show non-inferior adhesion of the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component.

Conditions

  • Healthy

Interventions

DRUG

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

A single transdermal contraceptive patch of EVRA (NGMN + 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, that is, on Day 8.

DRUG

High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)

A single transdermal contraceptive HMW PIB (NGMN + EE) patch 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, that is, 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
2019-07-12
Primary Completion
2019-12-13
Completion
2019-12-13

Countries

  • Belgium
  • Germany
  • Netherlands

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 NCT04017195 on ClinicalTrials.gov