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

NCT ID: NCT00460070

Last Updated: 2011-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-03-31

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.

Conditions

Epilepsy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Rikshospitalet University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dep of Neurology, Rikshospitalet, OSLO

Principal Investigators

Erik Taubøll, MD

Role: PRINCIPAL_INVESTIGATOR

unaffiliation

Locations

Dep. of Neurology, Rikshospitalet Universty Hospital

Oslo, Oslo County, Norway

Countries

Norway

References

Bachmann T, Bertheussen KH, Svalheim S, Rauchenzauner M, Luef G, Gjerstad L, Tauboll E. Haematological side effects of antiepileptic drug treatment in patients with epilepsy. Acta Neurol Scand Suppl. 2011;(191):23-7. doi: 10.1111/j.1600-0404.2011.01539.x.

Reference Type: RESULT

PMID: 21711253 (View on PubMed)

Svalheim S, Luef G, Rauchenzauner M, Morkrid L, Gjerstad L, Tauboll E. Cardiovascular risk factors in epilepsy patients taking levetiracetam, carbamazepine or lamotrigine. Acta Neurol Scand Suppl. 2010;(190):30-3. doi: 10.1111/j.1600-0404.2010.01372.x.

Reference Type: RESULT

PMID: 20586732 (View on PubMed)

Svalheim S, Tauboll E, Luef G, Lossius A, Rauchenzauner M, Sandvand F, Bertelsen M, Morkrid L, Gjerstad L. Differential effects of levetiracetam, carbamazepine, and lamotrigine on reproductive endocrine function in adults. Epilepsy Behav. 2009 Oct;16(2):281-7. doi: 10.1016/j.yebeh.2009.07.033. Epub 2009 Aug 27.

Reference Type: RESULT

PMID: 19716343 (View on PubMed)

Other Identifiers

M52332

Identifier Type: -

Identifier Source: org_study_id