Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04017195 | 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 | PHASE1 | COMPLETED | 68 | — | — | Jul 12, 2019 | Dec 13, 2019 | Apr 27, 2025 | 3 | Belgium, Germany +1 |
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...