Gonadal dysfunction in male long-term survivors of malignant lymphoma

Phase 1

• Conditions: Hypogonadism; MedDRA version: 20.0Level: LLTClassification code 10043335Term: Testicular hypogonadismSystem Organ Class: 100000004860; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2020-002140-22-DK
• Lead Sponsor: ars møller Pedersen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-16
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

Age 18-65 years at inclusion
Male
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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The approach to surveillance and treatment of gonadal dysfunction following remission with first line therapy for malignant lymphoma remains controversial. With a paucity of evidence whether follow-up programs and treatment are effective, evidence-based guidelines for follow-up and treatment of gonadal dysfunction are needed. The main purpose of the current study is to assess the extent of sexual dysfunction, quality of life (QoL) and reduced levels of testosterone in male patients with Hodgkin lymphoma (HL) and diffuse large B-cell lymphoma (DLBCL). Furthermore, in a prospective phase 2 study, to test the impact on QoL before and after substitution with testosterone in patients with reduced levels of testosterone.;Secondary Objective: Not applicable;Primary end point(s): Effect of treatment with testosterone (Testogel) on QLQ C30 score.;Timepoint(s) of evaluation of this end point: At baseline, after 1,3,6 and 12 months.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Effect of treatment with testosterone on SHQ-C22 score.<br>Effect of treatment with testosterone on IIEF-5 score<br>S-testosterone<br>Testosterone dose needed<br>;Timepoint(s) of evaluation of this end point: At baseline and after 1,3,6 and 12 months.