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Could a lifesaving leukemia drug harm Men's sexual health?

NCT ID NCT07061145

Knowledge-focused Sponsor: Azienda USL Reggio Emilia - IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This study looks at whether tyrosine kinase inhibitors (TKIs), the standard treatment for chronic myeloid leukemia (CML), might be linked to erectile dysfunction (ED) in men. Researchers will track 350 male patients who started TKI therapy, using questionnaires and medical records to see how many develop ED and whether the type of TKI matters. The goal is to better understand the long-term side effects of these drugs and potentially improve patient care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tyrosine kinase inhibitors (TKIs) such as imatinib, dasatinib, nilotinib, bosutinib, or ponatinib, given as standard care for chronic myeloid leukemia.
What this could lead to
If a link is confirmed, it could lead to better monitoring and management of erectile dysfunction in men taking TKIs, improving quality of life and potentially aiding early detection of cardiovascular risk.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The results may be influenced by other factors, and the findings might not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult male patients (aged 18-75) diagnosed with chronic-phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), who initiated frontline treatment with tyrosine kinase inhibitors (TKIs) between January 1, 2015, and January 31, 2022. Patients must not have experienced erectile dysfunction (ED) before TKI initiation. Both retrospective and prospective clinical data will be collected to assess the occurrence and characteristics of ED and related cardiovascular events.

Ages

18 to 75 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder chronic myelogenous leukemia, BCR-ABL1 positive erectile dysfunction Leukemia, Myelogenous, Chronic, BCR-ABL Positive

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic myelocytic leukemia CVD - cardiovascular disease Erectile dysfunctions Tyrosine kinase inhibitor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda USL IRCCS di Reggio Emilia

    RECRUITING

    Reggio Emilia, RE, 42121, Italy

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Other studies related to the condition(s) this trial covers.