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Completed

NCT Number: NCT00460070

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of Neurology, Rikshospitalet Universty Hospital

Oslo, 0027, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Rikshospitalet University Hospital

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2007
Study completion
2009
First posted
Apr 13, 2007
Registry last updated
Jul 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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