Status:
UNKNOWN
Hormone Profiles in Adults With Newly Diagnosed Epilepsy
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Epilepsy
Eligibility:
All Genders
15-55 years
Phase:
PHASE4
Brief 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 b...
Detailed Description
Sodium valproate is an established antiepileptic drug used against a broad range of seizure types. Lamotrigine, a newer antiepileptic drug available since late 1980s, has a similar range of action and...
Eligibility Criteria
Inclusion
- 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epilepsy requiring antiepileptic drug treatment; or patients previously treated with antiepileptic drugs but have withdrawn from medication for at least 1 year, and now require resumption of antiepileptic drug therapy due to seizure relapse.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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00137709
Start Date
November 1 2004
End Date
July 1 2008
Last Update
October 31 2007
Active Locations (2)
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1
United Christian Hospital
Kowloon, Hong Kong
2
Prince of Wales Hospital
Shatin, Hong Kong