The influence of oral contraceptives on lamotrigine clearance in patients on lamotrigine in combination with valproic acid, carbamazepine or oxcarbazepine as compared to patients on lamotrigine only.
Completed
- Conditions
- epilepsy10029305
- Registration Number
- NL-OMON32536
- Lead Sponsor
- Stichting Epilepsie Instellingen Nederland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
Inclusion Criteria
women in the age of 18-40 years that use OC in a stable dose as well as a stable dose of 1)LTG and VPA, 2)LTG and CBZ, 3)LTG and OCB.
Exclusion Criteria
Use of steroid hormones (other than OC) as well as pregnancy or the intention to conceive, current breastfeeding or having delivered in the nine months prior to the study. Patients with abnormal liver and/or renal function or with known gynaecological or psychiatric co morbidity will be excluded.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>LTG serum levels as well as serum levels of VPA, or CBZ or OCB during the<br /><br>cycles will be primary study parameters.</p><br>
- Secondary Outcome Measures
Name Time Method <p>seizures and side effects will be secundary parameters.</p><br>