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| ID | Type | Description | Link |
|---|---|---|---|
| NRGEEPCON4015 | Other Identifier | Janssen-Cilag Farmaceutica Ltda. |
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The purpose of this study is to evaluate the contraceptive efficacy, safety, cycle control, compliance, and subject satisfaction of the transdermal contraceptive system, norelgestromine and ethinyl estradiol (NLGM / EE).
A multicenter, open label, descriptive study. Five hundred requiring contraception will receive the weekly transdermal contraceptive patch for 6 cycles. At the baseline and after the 1st, 3rd and 6th cycles, satisfaction with the method will be assessed. The contraceptive efficacy will be assessed by the Pearl Index and by life table analysis. To assess satisfaction with the weekly transdermal contraceptive patch, this method will be compared to the previous contraceptive method. Adhesion, cycle control, safety and efficacy are secondary outcomes. Treatment duration: 6 cycles (4 weeks each). The subject will wear a 20 cm2 contraceptive transdermal patch for one full week, apply a fresh patch for week 2, and a third patch for week 3. The fourth week will be patch-free. Each patch deliveries 150 mcg of NLGM and 20 mcg of EE per day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norelgestromine (NLGM)/Ethinyl Estradiol (EE) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norelgestromine (NLGM)/ethinyl estradiol (EE) | Drug | Participants will apply a 20 centimeter square (cm^2) contraceptive transdermal patch on the skin for 1 full week, and then apply a fresh patch for Week 2, and a third patch for Week 3. The fourth week will be patch-free. Each patch delivers 150 microgram (mcg) of NLGM and 20 mcg of EE per day. The treatment duration is of 6 cycles (4 weeks each). |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy Rate Determined by Pearl Index | Pearl Index is the number of pregnancies with use of therapy divided by the number of cycles with therapy use. It is an estimation of the number of pregnancies per 100 woman-years of product use. | Cycle 6 (Day 168) |
| Pregnancy Rate Determined by Table of Life Analysis | Pregnancy rate was determined by table of life analysis. | Cycle 6 (Day 168) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Breakthrough Bleeding and/or Spotting | Percentage of participants with breakthrough bleeding and/or spotting was reported. | Day 28 of Cycle 1, 3 and 6 |
| Compliance Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Farmaceutica Ltda. Clinical Trial | Janssen-Cilag Farmaceutica Ltda. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belo Horizonte | Brazil | |||||
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Score of compliance was calculated for each participant by dividing the number of cycles with at least one day without the study drug by the total number of therapy cycles. Average score was calculated for cycle 1 to 6.
| Day 28 of Cycle 1, 2, 3, 4, 5 and 6 |
| Percentage of Participants With Response to Satisfaction Questionnaire | Percentage of participants with response to satisfaction questionnaire was reported for following categories: previous contraceptive, method election, physical well-being, emotional well-being, intermenstrual bleeding and intensity, menstrual flow volume, pre-menstrual symptoms, and easiness in ethinyl estradiol and norelgestromin transdermal patch use. | Day 28 of Cycle 1, 3 and 6 |
| Botucatu |
| Brazil |
| Brasília | Brazil |
| Curitiba | Brazil |
| Goiânia | Brazil |
| Porto Alegre | Brazil |
| Ribeirão Preto | Brazil |
| São Paulo | Brazil |
| Sorocaba | Brazil |
| Mexico City | Mexico |
| México | Mexico |
| Monterrey | Mexico |