Viewing Study NCT00460070



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Last Modification Date: 2024-10-26 @ 9:32 AM
Study NCT ID: NCT00460070
Status: COMPLETED
Last Update Posted: 2011-07-27
First Post: 2007-04-12

Brief Title: Study of Hormonal Sideeffects in Patients Taking Levetiracetam Carbamazepine or Lamotrigine for Epilepsy
Sponsor: Rikshospitalet University Hospital
Organization: Rikshospitalet University Hospital

Study Overview

Official Title: Levetiracetam Carbamazepine and Lamotrigine and Hormonal Side Effects in Adult Males and Females
Status: COMPLETED
Status Verified Date: 2009-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 corpora 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None