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We suspended the study for budget issues. It might be resumed in the future.
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Data on the interaction between the etonogestrel (ENG) implant and antiepileptic drug (AED) regimen are scarce. We will evaluated the effect of 2 AED regimens (1 including carbamazepine and the other topiramate) on the pharmacokinetic (PK) parameters of an ENG-releasing implant in women with epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbamazepine-Implant | Experimental | Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted |
|
| Topiramate-Implant | Experimental | Women with epilepsy using topiramate for at least 3 months will have an etonogestrel-releasing implant inserted |
|
| Implant | Active Comparator | Women without epilepsy and not using an anti-epileptic drug will have an etonogestrel-releasing implant inserted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbamazepine-Implant | Drug | Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using carbamazepine | Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for area under the curve evaluation of ENG (AUC, 0-24 weeks). The plasma ENG AUC will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement. | Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement |
| Plasma maximum concentration (Cmax) of ENG in women with epilepsy (WWE) using carbamazepine | Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of plasma Cmax of ENG. The plasma ENG Cmax will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement. | Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement |
| Plasma minimum concentration (Cmin) of ENG in women with epilepsy (WWE) using carbamazepine | Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of plasma Cmin of ENG. The plasma ENG Cmin will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement. | Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement |
| Time to maximum concentration (Tmax) of ENG in women with epilepsy (WWE) using carbamazepine | Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of Tmax of ENG. The Tmax of ENG will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement. |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding pattern associated with etonogestrel implant use | Bleeding pattern (frequency, duration and number of bleeding/spotting days) associated with etonogestrel implant use will be evaluated in WWE using carbamazepine or topiramate and in women without epilepsy and without antiepileptic drug use | Daily for 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | A questionnaire will be used to measure acceptability to etonogestrel implant by WWE | At 24 weeks of implant placement |
| Satisfaction | A questionnaire will be applied to measure satisfaction of WWE with etonogestrel implant |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolina S Vieira, MD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClÃnicas de Ribeirão Preto da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo | Ribeirão Preto | São Paulo | 14049-900 | Brazil |
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| ID | Term |
|---|---|
| D004343 | Drug Implants |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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It is a non-randomized clinical trial (controlled clinical trial)
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| Topiramate-Implant | Drug | Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted |
|
| Implant | Drug | Women without epilepsy and not using an anti-epileptic drug will have an etonogestrel-releasing implant inserted |
|
| Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement |
| Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using topiramate |
Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for area under the curve evaluation of ENG (AUC, 0-24 weeks). The plasma ENG AUC will be compared to that of women without epilepsy and without topiramate use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement. |
| Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement |
| Plasma maximum concentration (Cmax) of ENG in women with epilepsy (WWE) using topiramate | Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of plasma Cmax of ENG. The plasma ENG Cmax will be compared to that of women without epilepsy and without topiramate use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement. | Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement |
| Plasma minimum concentration (Cmin) of ENG in women with epilepsy (WWE) using topiramate | Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of plasma Cmin of ENG. The plasma ENG Cmin will be compared to that of women without epilepsy and without topiramate use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement. | Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement |
| Time to maximum concentration (Tmax) of ENG in women with epilepsy (WWE) using topiramate | Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of Tmax of ENG. The Tmax of ENG will be compared to that of women without epilepsy and without topiramate use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement. | Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement |
| Area under the plasma concentration versus time curve (AUC) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement | Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate AUC (0-8 hours) of carbamazepine | Prior to implant placement and at 24 weeks of implant use |
| Plasma maximum concentration (Cmax) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement | Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmax of carbamazepine | Prior to implant placement and at 24 weeks of implant use |
| Plasma minimum concentration (Cmin) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement | Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmin of carbamazepine | Prior to implant placement and at 24 weeks of implant use |
| Time to maximum concentration (Tmax) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement | Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Tmax of carbamazepine | Prior to implant placement and at 24 weeks of implant use |
| Area under the plasma concentration versus time curve (AUC) of topiramate in women with epilepsy (WWE) before and after ENG implant placement | Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate AUC (0-8 hours) of topiramate | Prior to implant placement and at 24 weeks of implant use |
| Plasma maximum concentration (Cmax) of topiramate in women with epilepsy (WWE) | Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmax of topiramate | Prior to implant placement and at 24 weeks of implant use |
| Plasma minimum concentration (Cmin) of topiramate in women with epilepsy (WWE) before and after ENG implant placement | Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmin of topiramate | Prior to implant placement and at 24 weeks of implant use |
| Time to maximum concentration (Tmax) of topiramate in women with epilepsy (WWE) before and after ENG implant placement | Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Tmax of topiramate | Prior to implant placement and at 24 weeks of implant use |
| At 24 weeks of implant placement |