Study of Hormonal Sideeffects in Patients Taking Levetiracetam, Carbamazepine or Lamotrigine for Epilepsy
Information source: Rikshospitalet University Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Phase: N/A
Status: Recruiting
Sponsored by: Rikshospitalet University Hospital Official(s) and/or principal investigator(s):
Erik Taubøll, MD, Principal Investigator, Affiliation: unaffiliation
Overall contact:
Erik Taubøll, MD, Phone: +4723070000, Email: erik.tauboll@rikshospitalet.no
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.
Clinical Details
Official title: Levetiracetam, Carbamazepine and Lamotrigine and Hormonal Side Effects in Adult Males and Females.
Study design: Natural History, Cross-Sectional, Defined Population, Prospective Study
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
corporea 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
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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 anticonseption drugs or other hormonal drugs.
Locations and Contacts
Erik Taubøll, MD, Phone: +4723070000, Email: erik.tauboll@rikshospitalet.no
Dep. of Neurology, Rikshospitalet Universty Hospital, Oslo 0027, Norway; Recruiting
Erik Taubøll, MD, Phone: +47 23073580, Email: erik.tauboll@rikshospitalet.no
Sigrid Svalheim, MD, Phone: +47 23073580, Email: sigrid.svalheim@rikshospitalet.no
Additional Information
Starting date: January 2007
Ending date: December 2007
Last updated: April 12, 2007
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