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临床试验/EUCTR2020-002140-22-DK
EUCTR2020-002140-22-DK进行中(未招募)1 期

Gonadal dysfunction in male long-term survivors of malignant lymphoma

ars møller Pedersen0 个研究点目标入组 150 人开始时间: 2020年6月16日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
150

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Male

入选标准

  • Age 18-65 years at inclusion
  • Verified diagnosis of de novo DLBCL or classical HL diagnosed between april 2013 and april 2018 according to WHO classification.
  • Disease in complete remission for at least 2 years at inclusion.
  • Completed curative intent first line treatment with anthracycline-containing chemotherapy with or without consolidating radiotherapy
  • Literate in Danish
  • Serum testosterone level below age-adjusted reference level.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 7
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Concurrent low-grade lymphoma
  • Current or prior lymphoma of the central nervous system (CNS)
  • Current or prior lymohoma of the testes
  • Verified prostate cancer, cancer of the mammae, primary liver cancer-related, polycythaemia vera
  • Mental or physical conditions that are expected to prevent the necessary compliance and/or adherence in relation to the study procedures
  • Contraindications for the treatment with testosterone: PSA > 3 ng/ml, Hct > 0,49
  • Treatment with second line chemotherapy or high dose therapy.
  • Current or prior anabolic steroid abuse
  • Known sexual dysfunction prior to enrolment.

研究者

发起方
ars møller Pedersen

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