Hormone Profiles in Adults With Newly Diagnosed Epilepsy

• Status: Unknown status
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Both sodium valproate and lamotrigine are currently used in the treatment of newly diagnosed epilepsy. Although they appear to have similar efficacy, they have different side effects, which have not been well studied. This study aims to compare one particular aspect of their possible side effects, namely whether they affect certain hormonal functions.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Hormones; Lamotrigine; Valproic Acid

Criteria

Inclusion Criteria:

• Patients aged between 15 and 55

• Ethnically Chinese

• Newly diagnosed epilepsy requiring antiepileptic drug treatment; or patients previously treated with antiepileptic drugs but have withdrawn from medication for at least 1 year, and now require resumption of antiepileptic drug therapy due to seizure relapse.

Exclusion Criteria:

• Post-menopausal women.

• Pregnant women.

• Women who have undergone oophorectomy.

• Women taking or have taken oral contraceptive pills in the previous 3 months.

• Women diagnosed with or suspected to have polycystic ovarian syndrome.

• Subjects with diabetes mellitus.

• Subjects receiving hormone replacement or glucocorticoids.

• Subjects receiving long-term warfarin.

• Subjects suffering from significant systemic diseases, or illnesses that interfere with pituitary-gonadal functions.

• Subjects with a progressive or degenerative neurological disorder.

• Subjects who are unable to take their medication reliably.