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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001893-27 | EudraCT Number | ||
| RWJ10553CON1019 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Group 4: Sequence BA (Left/Right) |
| 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) 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Belgium NV | Antwerp | 2060 | Belgium | |||
| Charite - Universitaetsmedizin Berlin (CCM) |
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
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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. |
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| 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. |
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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 |
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 |
| Berlin |
| 10117 |
| Germany |
| PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini | Groningen | 9728 NZ | Netherlands |
| ID | Term |
|---|---|
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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