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

A Randomized, Double-blind, 2-Way Crossover Bioequivalence and Adhesion Study of a Transdermal Contraceptive Patch Manufactured With Newly Sourced Adhesive Components at the End of Shelf Life and Currently Marketed EVRA® at the Beginning of Shelf Life in Healthy Adult Women

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference); Drug: High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, 2060
    • SGS Belgium NV
• Germany
  • Berlin, Germany, 10117
    • Charite - Universitaetsmedizin Berlin (CCM)
• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participant has a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2), inclusive, and body weight not less than 50 kilogram (kg) and not more than 100 kg at screening
• Participant must be surgically sterile with intact ovaries, abstinent, or, if sexually active, be practicing a highly effective method (that is, failure rate of less than [<] 1 percent [%] per year) of non hormonal contraception (example, intrauterine device [IUD], male partner sterilization) before admission and throughout the study
• Participant has a blood pressure (after the participant is supine or sitting for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening
• Participant must have a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at screening, including: Normal sinus rhythm with heart rate between 45 and 100 beats per minute (bpm), extremes included; QT interval corrected for heart rate (QTc) according to Fridericia's formula (QTcF) =<470 millisecond (ms); QRS interval =<120 ms; PR interval =<220 ms. ECG morphology consistent with healthy cardiac conduction and function. Any evidence of heart block and left or right bundle branch block is exclusionary
• Participant must be a non-smoker, ex-smoker for greater than (>) 6 months, must not use nicotine containing substances including tobacco products (example, cigarettes, e-cigarettes. cigars, chewing tobacco, gum, patch), or tests negative for cotinine at screening and on Day 1 of each treatment period

Exclusion Criteria:

• Participant has clinically significant abnormal values for hematology, biochemistry, or urinalysis at screening as deemed appropriate by the investigator
• Participant has abnormal thyroid stimulating hormone level at screening
• Participant has evidence of cervical dysplasia as documented by a CytoRich test or Papanicolaou (PAP) smear test within 10 months before screening. If a PAP smear has been done within 10 months prior to screening and results are available (documentation is available at the study site) a cervical smear does not need to be performed
• Participant has used oral hormonal contraception, that is, contraceptive pills, within 3 months before admission to the study site on Day -1 of Treatment Period 1
• Participant currently has a contraceptive implant such as Implanon or Norplant in place, or has had removal of contraceptive implant within the 3 months before admission to the study site on Day -1 of Treatment Period 1

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Sequence AB (Right/Left); A single patch of currently marketed EVRA patch using the adhesive component at the beginning of shelf life (BOSL) (Treatment A) will be applied to the right buttock of participants on Day 1 of Treatment Period 1, followed by application of a single patch of transdermal contraceptive using newly sourced adhesive component HMW PIB at the end of shelf life (EOSL) (Treatment B) to left buttock of participants on Day 1 of Treatment Period 2. The Treatment periods will be separated by a washout period of 21 days.	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.; Other Names: RWJ10553; 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.
Experimental: Group 2: Sequence BA (Right/Left); Treatment B will be applied to the right buttock of participants on Day 1 in Period 1, followed by Treatment A to the left buttock on Day 1 in Period 2. The Treatment periods will be separated by a washout period of 21 days.	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.; Other Names: RWJ10553; 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.
Experimental: Group 3: Sequence AB (Left/Right); Treatment A will be applied to the left buttock of participants on Day 1 in Period 1, followed by Treatment B to the right buttock on Day 1 in Period 2. The Treatment periods will be separated by a washout period of 21 days.	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.; Other Names: RWJ10553; 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.
Experimental: Group 4: Sequence BA (Left/Right); Treatment B will be applied to the left buttock of participants on Day 1 in Period 1, followed by Treatment A to the right buttock on Day 1 in Period 2. The Treatment periods will be separated by a washout period of 21 days.	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.; Other Names: RWJ10553; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Steady-State Concentration (Css) of Norelgestromin (NGMN)	Css is the mean steady-state concentration for NGMN after patch application, will be calculated, as the mean concentration between 48 hours and 168 hours, inclusive, after patch application.	48 to 168 hours post-dose
Mean Steady-State Concentration (Css) of Ethinyl Estradiol (EE)	Css is the mean steady-state concentration for EE after patch application, will be calculated, as the mean concentration between 48 hours and 168 hours, inclusive, after patch application.	48 to 168 hours post-dose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of NGMN	Tmax is the time to reach the maximum observed plasma concentration of NGMN will be assessed.	Predose, 24, 48, 72, 96, 120, 144, 168, 168.5, 171, 174, 180, 192, 216 and 240 hours post dose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of EE	Tmax is the time to reach the maximum observed plasma concentration of EE will be assessed.	Predose, 24, 48, 72, 96, 120, 144, 168, 168.5, 171, 174, 180, 192, 216 and 240 hours post dose
Area Under the Plasma Concentration-Time Curve from Time 0 (Patch Application) to Time 168 hours Post-dose (AUC[0-168]) of NGMN	AUC(0-168) is the area under the concentration versus time curve from zero (patch application) to 168 hours of NGMN in plasma will be assessed.	Pre-dose to 168 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 168 hours Post-dose (AUC[0-168]) of EE	AUC(0-168) is the area under the concentration versus time curve from zero (patch application) to 168 hours of EE in plasma will be assessed.	Pre-dose to 168 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 240 hours Post-dose (AUC[0-240]) of NGMN	AUC(0-240) is the area under the concentration versus time curve from zero (patch application) to 240 hours of NGMN in plasma will be assessed.	Pre-dose to 240 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 240 hours Post-dose (AUC[0-240]) of EE	AUC(0-240) is defined as area under the concentration versus time curve from zero (patch application) to 240 hours of EE in plasma will be assessed.	Pre-dose to 240 hours post-dose
Cumulative Adhesion Percentage Ratio	Adhesion of patches will be assessed in accordance with the European Medicines Agency (EMA) 0-5 scoring system. An estimated percentage of adhesion, to a whole integer, will be obtained (EMA 0-5 [percentage (%)] scoring). Estimated percentages of adhesion and corresponding EMA 0-5 score at each interval will be recorded in each participant's electronic case report form. The scoring system for adhesion of transdermal patches is indicated as follows : 0= greater than (>) 90-100% of the patch area adheres; 1= >80-90% of the patch area adheres; 2= >70-80% of the patch area adheres; 3= >60-70% of the patch area adheres; 4= >50-60% of the patch area adheres; 5= 0-less than or equal to (<=) 50% of the patch area adheres.	Baseline (Day 1) and every 24 hours after patch application up to patch removal at 168 hours (Day 8)]
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Infinite Time (AUC[0-infinity]) for NGMN	AUC (0-infinity) is the area under the concentration versus time curve from zero (patch application) to infinite time of NGMN in plasma will be assessed.	Pre-dose to 240 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Infinite Time (AUC[0-infinity]) for EE	AUC (0-infinity) is the area under the concentration versus time curve from zero (patch application) to infinite time of EE in plasma will be assessed.	Pre-dose to 240 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Specific Application Site Reactions	Percentage of participants with specific application site reactions (including erythema, edema, pustules, papules and itching) will be summarized for each treatment.	Pre-dose, 168.5, and 192 hours post-dose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to 97 Days

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2019
• Primary Completion (Actual): December 13, 2019
• Study Completion (Actual): December 13, 2019

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CR108645; 2019-001893-27 (EudraCT Number); RWJ10553CON1019 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No