Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EVRA patch · 1 trial · 1 indication
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.
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.
Tmax is the time to reach the maximum observed plasma concentration of NGMN will be assessed.
Tmax is the time to reach the maximum observed plasma concentration of EE will be assessed.
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.
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Group 1: Sequence AB (Right/Left) | EXPERIMENTAL | 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. |
| 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 |
|---|---|---|
| EVRA patch (NGMN+EE) (Treatment A) (Reference) | DRUG | 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. |
| High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test) | DRUG | 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. |
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 sexual...
The EVRA patch is a transdermal contraceptive patch developed by Johnson & Johnson (ticker JNJ). It is a small molecule product studied in healthy women. The EVRA patch is also known as EVRA patch (NGMN+EE) (Treatment A) (Reference), which reflects its combination of norelgestromin and ethinyl estradiol.
The EVRA patch is made by Johnson & Johnson, which trades under the ticker JNJ. Johnson & Johnson is the developer of the transdermal contraceptive patch and sponsored the clinical study evaluating it in healthy women.
The EVRA patch has been studied in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The completed study enrolled 68 participants and was randomized, double-blind, and controlled.
The EVRA patch was evaluated in one completed Phase 1 trial, NCT04017195, titled 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. It enrolled 68 healthy female participants aged 18 years and older across Belgium, Germany, and the Netherlands.