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Study of Hormonal Sideeffects in Patients Taking Levetiracetam, Carbamazepine or Lamotrigine for Epilepsy

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ClinicalTrials.gov Identifier: NCT00460070
Recruitment Status : Completed
First Posted : April 13, 2007
Last Update Posted : July 27, 2011
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Rikshospitalet University Hospital

April 12, 2007
April 13, 2007
July 27, 2011
January 2007
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Complete list of historical versions of study NCT00460070 on ClinicalTrials.gov Archive Site
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Study of Hormonal Sideeffects in Patients Taking Levetiracetam, Carbamazepine or Lamotrigine for Epilepsy
Levetiracetam, Carbamazepine and Lamotrigine and Hormonal Side Effects in Adult Males and Females.
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Probability Sample
Patients from the outpatients clinic
Epilepsy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
Same as current
March 2009
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Inclusion Criteria:

  • Having epilepsy
  • Age 18- 45
  • Using levetiracetam/ lamotrigine or carbamazepine in monotherapy for at least 6 months

Exclusion Criteria:

  • Hormonal diseases( ie; diabetes, hypo/ hyperthyroid disease)
  • Use of hormonal anticonception drugs or other hormonal drugs.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT00460070
M52332
No
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Erik Taubøll, Professor, Dep of Neurology, Rikshospitalet, OSLO
Rikshospitalet University Hospital
GlaxoSmithKline
Principal Investigator: Erik Taubøll, MD unaffiliation
Rikshospitalet University Hospital
October 2009