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| ID | Type | Description | Link |
|---|---|---|---|
| NRGEEPCON1017 | Other Identifier | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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The purpose of this study is to assess the bioequivalence of the contraceptive hormones of ORTHO EVRA when the patch is applied with and without an adhesive overlay.
This is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), single-center, single-application, 2-way crossover study (participants receive different interventions sequentially during the trial) of ORTHO EVRA with and without an adhesive overlay. ORTHO EVRA is a combination transdermal (through the skin) contraceptive patch containing 6.00 mg of the progestin norelgestromin (NGMN) and 0.75 mg of the estrogen, ethinyl estradiol (EE). The participants will be randomly assigned to 1 of 2 possible treatment sequences to ensure that they receive both of the following treatments, 1 in each period: - Treatment A: ORTHO EVRA patch applied to the buttock with an adhesive overlay applied over the transdermal contraceptive system; - Treatment B: ORTHO EVRA patch applied to the buttock without an overlay. The study consists of a screening phase; an open-label treatment phase consisting of 2 single-application 7-day treatment periods; and end-of-study or withdrawal assessments done upon completion of the 240-hour pharmacokinetic sampling on Day 11 of Period 2 or upon withdrawal. Pharmacokinetic evaluations explore how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time. The two treatment periods will be separated by a washout period (period when receiving no treatment) of 21 days. During the study, safety and tolerability will also be assessed. The total duration of participation in the study for an individual will be approximately 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence AB | Experimental |
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| Treatment sequence BA | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay | Drug | NGMN: type= exact number, unit= mg, number= 6, form= transdermal patch, route= transdermal use. EE: type= exact number, unit= mg, number= 0.75, form= transdermal patch, route= transdermal use. A single patch is applied to the buttock with an adhesive overlay applied over the transdermal contraceptive system for 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| NGMN plasma concentrations (Periods 1 and 2) | At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours. | |
| EE plasma concentrations (Periods 1 and 2) | At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of NGMN (Periods 1 and 2) | Pharmacokinetic parameters of NGMN as measured by AUC, Cmax, tmax, and Css. | At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours. |
| Pharmacokinetic parameters of EE (Periods 1 and 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neptune City | New Jersey | United States |
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| Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay | Drug | NGMN: type= exact number, unit= mg, number= 6, form= transdermal patch, route= transdermal use. EE: type= exact number, unit= mg, number= 0.75, form= transdermal patch, route= transdermal use. A single patch is applied to the buttock without an overlay for 7 days. |
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Pharmacokinetic parameters of EE as measured by AUC, Cmax, tmax, and Css. |
| At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours. |
| Incidence of adverse events as a measure of safety and tolerability | Approximately 2 months |
| The number of patients with changes in clinical laboratory test values, physical examination results, and vital signs measurements | Approximately 2 months |