A Potential Relationship Between Treatment With Tyrosine Kinase Inhibitors and Erectile Dysfunction in Male Patients With Chronic Myeloid Leukemia

Launched by AZIENDA USL REGGIO EMILIA - IRCCS · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether treatment with a group of medicines called tyrosine kinase inhibitors (TKIs), used to manage chronic myeloid leukemia (CML), might be linked to erectile dysfunction (ED) in men. CML is a type of blood cancer that has become much more manageable thanks to these medicines, which patients often need to take for a long time. Since long-term use can sometimes cause side effects, this study aims to better understand if and how these treatments might affect sexual health, especially the development of ED after starting therapy.

Men aged 18 to 75 who have been diagnosed with a specific type of CML and have started TKI treatment between 2015 and 2022 may be eligible. Participants will have their medical history reviewed to see if they developed ED after beginning treatment, and their health will be monitored over the next two years to track any new symptoms. The study involves checking past medical records and conducting regular health assessments but does not involve changing or adding treatments. The goal is to help doctors and patients better understand potential side effects of these important cancer medicines, so any issues can be identified and managed early.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Patients diagnosed with chronic phase Philadelphia chromosome-positive (Ph+) and/or BCR-ABL-positive CML.
• • Patients starting frontline treatment with TKIs between 01st January 2015 and 31st January 2022.
• • Age greater than or equal to 18 years and not exceeding 75 years at the time of starting therapy.
• • Male sex.
• • Exposure to Hydroxyurea or Anagrelide before the initiation of TKI therapy is allowed
• • Ability to provide informed consent, as demonstrated by a clear understanding of the study's objectives and procedures and the ability to make an informed and voluntary decision to participate
• • Signed written informed consent according to ICH/EU/GCP and national and local laws.
• Exclusion Criteria:
• • Patients with advanced phases (accelerated or blastic phase) Ph+ and/or BCR-ABL+ CML
• • Patients who experienced ED before TKI initiation