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Study of Hormonal Sideeffects in Patients Taking Levetiracetam, Carbamazepine or Lamotrigine for Epilepsy
This study is currently recruiting participants.
Verified by Rikshospitalet University Hospital, October 2009
First Received: April 12, 2007   Last Updated: October 2, 2009   History of Changes
Sponsor: Rikshospitalet University Hospital
Collaborator: 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: Cohort, Cross-Sectional
Official Title: Levetiracetam, Carbamazepine and Lamotrigine and Hormonal Side Effects in Adult Males and Females.

Resource links provided by NLM:


Further study details as provided by Rikshospitalet University Hospital:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 240
Study Start Date: January 2007
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients from the outpatients clinic

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460070

Contacts
Contact: Erik Taubøll, MD +4723070000 erik.tauboll@rikshospitalet.no
Contact: Sigrid Svalheim, MD ?4723070000 sigrid.svalheim@rikshospitalet.no

Locations
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    
Sponsors and Collaborators
Rikshospitalet University Hospital
GlaxoSmithKline
Investigators
Principal Investigator: Erik Taubøll, MD unaffiliation
  More Information

No publications provided

Responsible Party: Dep of Neurology, Rikshospitalet, OSLO ( Erik Taubøll, Professor )
Study ID Numbers: M52332
Study First Received: April 12, 2007
Last Updated: October 2, 2009
ClinicalTrials.gov Identifier: NCT00460070     History of Changes
Health Authority: Norway: The National Committees for Research Ethics in Norway

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 25, 2009