CompletedPhase 4

A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men

United States, Puerto Rico5,246 participantsStarted 2018-05-03

Plain-language summary

This is a double-blinded and placebo-controlled study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with pre-existing cardiovascular disease (CVD) or increased risk for CVD.

Who can participate

Age range

45 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men between 45 and 80 years age * Participants with low serum testosterone concentrations (\< 300 ng/dL) who exhibit at least one sign or symptom of hypogonadism and have evidence of cardiovascular (CV) disease or are at an increased risk for CV disease. Exclusion Criteria: * Participants with congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate * Participants with prostate specific antigen (PSA) \> 3.0 ng/mL (or 1.5 if on 5-alpha reductase inhibitors) * Participants who have been treated with testosterone in the past 6 months and for whom testosterone therapy is contraindicated * Confirmed testosterone \< 100 ng/dL * Body Mass Index (BMI) \> 50 * Hemoglobin A1c (HbA1C) \> 11% * Hematocrit (Hct) \> 50% * Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min * History of deep vein thrombosis or pulmonary embolism or prostate cancer or heart failure (Class III and IV).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event

Timeframe: Randomization to event or last known date if no event (up to approximately 52 months)

Time From Randomization to the First Component Event of MACE

Timeframe: Randomization to event or last known date if no event (up to approximately 52 months)

Trial details

NCT IDNCT03518034

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-19

Results submitted2024-01-05

View on ClinicalTrials.gov More Hypogonadism trials

Who can participate

Age range

45 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event

Timeframe: Randomization to event or last known date if no event (up to approximately 52 months)

Time From Randomization to the First Component Event of MACE

Timeframe: Randomization to event or last known date if no event (up to approximately 52 months)