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| Sponsors and Collaborators: |
Rikshospitalet University Hospital GlaxoSmithKline |
|---|---|
| Information provided by: | Rikshospitalet University Hospital |
| ClinicalTrials.gov Identifier: | NCT00460070 |
Purpose
Some antiepileptic drugs are found to have hormonal side effects. We want to study possible hormonal side effects of the relatively new antiepileptic drug; levetiracetam and compare it to the older drugs; lamotrigine and carbamazepine. The participants are going to fill in a questionnaire and we will collect blood samples from them, to analyse hormones.
| Condition |
|---|
|
Epilepsy |
| Study Type: | Observational |
| Study Design: | Natural History, Cross-Sectional, Defined Population, Prospective Study |
| Official Title: | Levetiracetam, Carbamazepine and Lamotrigine and Hormonal Side Effects in Adult Males and Females. |
| Estimated Enrollment: | 240 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | December 2007 |
We have previously performed long-term studies of rats treated with levetiracetam and compared them with a control group. Here we have found that levetiracetam has a probable effect on the ovaries, since the treated animals had larger ovaries, fewer cysts, more corporea lutea and more secondary follicles than the untreated animals (Taubøll et al 2004). Blood tests on the animals showed that those treated with levetiracetam had higher testosterone levels and lower levels of estrogen and FSH, whilst LH and progesterone levels were unaffected by the treatment (Svalheim et al, 2005a, b).
Studies on cell cultures from pig ovaries, as carried out by our group in collaboration with Jagiellonian University, Krakow, Poland, appeared to support these findings (Taubøll et al. 2006, submitted). Our wish therefore now is to study fertile men and women in order to look for any changes in the balance of sex hormones during use of levetiracetam in order to establish whether the findings in animal trials are clinically relevant to humans.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Erik Taubøll, MD | +4723070000 | erik.tauboll@rikshospitalet.no |
| Contact: Sigrid Svalheim, MD | ?4723070000 | sigrid.svalheim@rikshospitalet.no |
| Norway | |
| Dep. of Neurology, Rikshospitalet Universty Hospital | Recruiting |
| Oslo, Norway, 0027 | |
| Contact: Erik Taubøll, MD +47 23073580 erik.tauboll@rikshospitalet.no | |
| Contact: Sigrid Svalheim, MD +47 23073580 sigrid.svalheim@rikshospitalet.no | |
| Principal Investigator: | Erik Taubøll, MD | unaffiliation |
More Information
| Study ID Numbers: | M52332 |
| Study First Received: | April 12, 2007 |
| Last Updated: | April 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00460070 History of Changes |
| Health Authority: | Norway: The National Committees for Research Ethics in Norway |
|
Nootropic Agents Tranquilizing Agents Psychotropic Drugs Calcium Channel Blockers Central Nervous System Diseases Central Nervous System Depressants Cardiovascular Agents Brain Diseases Antimanic Agents |
Calcium, Dietary Carbamazepine Epilepsy Analgesics, Non-Narcotic Lamotrigine Etiracetam Analgesics Peripheral Nervous System Agents Anticonvulsants |
|
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Calcium Channel Blockers Brain Diseases Membrane Transport Modulators Sensory System Agents Therapeutic Uses Analgesics Nootropic Agents Tranquilizing Agents Nervous System Diseases Central Nervous System Diseases |
Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions Carbamazepine Analgesics, Non-Narcotic Epilepsy Lamotrigine Etiracetam Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |