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临床试验/NCT00460070
NCT00460070已完成不适用

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

Rikshospitalet University Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
240
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Having epilepsy
  • Age 18- 45
  • Using levetiracetam/ lamotrigine or carbamazepine in monotherapy for at least 6 months

排除标准

  • Hormonal diseases( ie; diabetes, hypo/ hyperthyroid disease)
  • Use of hormonal anticonception drugs or other hormonal drugs.

研究者

发起方
Rikshospitalet University Hospital
申办方类型
Other

研究点 (1)

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