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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.

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. - ltg/oc in combination therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON32536
Enrollment
28
Registered
2009-10-22
Start date
2010-02-09
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

epilepsy

Interventions

None listed

Sponsors

Stichting Epilepsie Instellingen Nederland
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Secondary

MeasureTime frame
seizures and side effects will be secundary parameters.

Primary

MeasureTime frame
LTG serum levels as well as serum levels of VPA, or CBZ or OCB during the cycles will be primary study parameters.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)