Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002186-22 | EudraCT Number | ||
| RWJ10553CON4001 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Sequence AB (Right/Left) | Experimental | A single patch of currently marketed EVRA patch (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 the newly sourced adhesive component HMW PIB (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. |
|
| Group 2: Sequence BA (Right/Left) | Experimental | 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. |
|
| Group 3: Sequence AB (Left/Right) | Experimental | 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. |
|
| Group 4: Sequence BA (Left/Right) | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVRA patch (NGMN+EE) (Treatment A) (Reference) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Steady-State Concentration (Css) for Norelgestromin (NGMN) | Mean steady-state concentration for NGMN after patch application, will be calculated as the mean concentration between 48 hours and 168 hours after patch application. | 48 to 168 hours post-dose |
| Mean Steady-State Concentration (Css) for Ethinyl Estradiol (EE) | Mean steady-state concentration for EE after patch application, will be calculated as the mean concentration between 48 hours and 168 hours after patch application. | 48 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]) for NGMN | 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]) for EE | 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]) for NGMN | 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]) for EE |
| Measure | Description | Time Frame |
|---|---|---|
| Irritation Potential | Percentage of participants with specific application site reactions will be summarized for each treatment. | Screening, pre-dose, 168.5 and 192 hours post-dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium |
Not provided
| Label | URL |
|---|---|
| A Randomized, Double-blind, 2-Way Crossover, Bioequivalence and Adhesion Study of a Transdermal Contraceptive Patch Manufactured With Newly Sourced Adhesive Components and Currently Marketed EVRA® in Healthy Adult Women | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
|
| HMW PIB patch (NGMN+EE) (Treatment B) (Test) | Drug | 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. |
|
|
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 |
| Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Infinite Time (AUC[0-infinity]) for NGMN | 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 | 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 |
| 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) |