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

Epilepsy Clinical Trial

Official title:

Levetiracetam, Carbamazepine and Lamotrigine and Hormonal Side Effects in Adult Males and Females.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00460070
• Other study ID #: M52332
• Status: Completed
• Phase: N/A
• First received: April 12, 2007
• Last updated: July 26, 2011
• Start date: January 2007
• Est. completion date: March 2009

Study information

• Verified date: October 2009
• Source: Rikshospitalet University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
Norway	Dep. of Neurology, Rikshospitalet Universty Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Rikshospitalet University Hospital	GlaxoSmithKline

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Bachmann T, Bertheussen KH, Svalheim S, Rauchenzauner M, Luef G, Gjerstad L, Taubøll 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. — View Citation

Svalheim S, Luef G, Rauchenzauner M, Mørkrid L, Gjerstad L, Taubøll 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. — View Citation

Svalheim S, Taubøll E, Luef G, Lossius A, Rauchenzauner M, Sandvand F, Bertelsen M, Mørkrid L, Gjerstad L. Differential effects of levetiracetam, carbamazepine, and lamotrigine on reproductive endocrine function in adults. Epilepsy Behav. 2009 Oct;16(2):2 — View Citation