NCT03274297View on ClinicalTrials.gov

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

PHASE4CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

September 20, 2017

Primary Completion Date

May 7, 2018

Study Completion Date

May 7, 2018

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.

Trial Locations (1)

2170

Clinical Pharmacology Unit, Merksem

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03274297 - 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 | Biotech Hunter | Biotech Hunter