Status:
COMPLETED
Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality
Lead Sponsor:
Lars Møller Pedersen
Collaborating Sponsors:
Besins Healthcare
Copenhagen University Hospital at Herlev
Conditions:
Hypogonadism
Eligibility:
MALE
18-65 years
Phase:
PHASE2
Brief Summary
This study is a prospective non-randomised open label multicenter phase two study in male long-term survivors of malignant lymphoma including Hodgkin Lymphoma (HL) and Diffuse Large B-Cell Lymphoma (D...
Detailed Description
Diffuse large B-cell lymphoma and Hodgkin Lymphoma are two aggressive lymphomas often treated with doxorubicin containing chemotherapy. Doxorubicin is an anthracycline and is known to be toxic to both...
Eligibility Criteria
Inclusion
- Age 18-65 years at inclusion
- Male
- Verified diagnosis of de novo DLBCL or classical HL diagnosed between April 2008 and April 2018 according to World Health Organization (WHO) classification.
- Completed curative intent first line treatment with anthracycline-containing chemotherapy with or without consolidating radiotherapy, with disease in complete remission at End of Treatment (EOT) Positron Emissions Tomography / Computerized Tomography (PET/CT) at least one year prior to inclusion.
- Literate in Danish
- Serum testosterone level below threshold for age adjusted reference level used in the local laboratory at the time of inclusion.
Exclusion
- Concurrent low-grade lymphoma
- Current or prior lymphoproliferative disease of the central nervous system (CNS)
- Current or prior lymphoproliferative disease of the testes
- Contraindications for the treatment with testosterone: Verified prostate cancer / Prostate Specific Antigen (PSA) \> 3 ng/ml, cancer of the mammae, primary liver cancer or polycythaemia vera / Hct \> 0,49.
- Mental or physical conditions that are expected to prevent the necessary "compliance" and/or "adherence" in relation to the study procedures
- Current or prior anabolic steroid drug abuse
- Treatment with second line chemotherapy or high dose therapy.
- Known allergies to additives in Testogel.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04492553
Start Date
April 1 2021
End Date
November 10 2022
Last Update
November 29 2022
Active Locations (3)
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1
Copenhagen University Hospital
Copenhagen, Denmark, 2100
2
Herlev University Hospital
Herlev, Denmark, 2730
3
Zealand University Hospital
Roskilde, Denmark, 4000