H-36731: Finasteride in Management of Elevated Red Blood Cells (NCT02548117) | Clinical Trial Compass
WithdrawnPhase 3
H-36731: Finasteride in Management of Elevated Red Blood Cells
Stopped: Funding was not available.
United States0Started 2016-02
Plain-language summary
Hypogonadism (low testosterone) is becoming an increasingly recognized problem that affects numerous men in the United States. Symptoms may be always feeling tired, lower sex drive, and loss of muscle mass. Treatment typically involves testosterone in either injections or a topical gel form.
However, administration of testosterone is not without side effects of its own. Testosterone supplementation therapy is known to cause a variety of side effects including high blood pressure and high lipids (fats) and an increased proportion of red blood cells. Side effects of increased red blood cells can include an increased risk of developing a blood clot.
The increase in the red blood cells is related to dihydrotestosterone (DHT - a male sex hormone) activity. It is normal for the testosterone to become DHT. DHT has various effects on the body including growth of the prostate gland, baldness, and others and DHT levels have been linked to elevated red blood cell counts in men on testosterone.
Finasteride is an FDA approved medication used in the treatment of benign prostatic hypertrophy (BPH) in men with enlarged prostate to improve symptoms and to reduce the risk of the need for surgery. Finasteride may prevent elevations in or reduce elevated red blood cell levels in men on testosterone.
Who can participate
Age range
18 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:
* Adult males 18 years of age or older
* Currently is being treated for hypogonadism with testosterone therapy using injectable testosterone.
* Must not have erythrocytosis (defined as a hematocrit of 52% or higher) attributable to other medication or medical condition
* Agree not to initiate any other treatment for erectile dysfunction (ED), including herbal and over- the-counter (OTC) medications, for the duration of the study.
* Must not already be taking finasteride or other 5-alpha reductase inhibitor
Exclusion Criteria:
* Men not currently using testosterone supplementation therapy or men on non-injectable testosterone therapy
* Prior history of anabolic steroid use, but have not used for at least 6 months
* Prior history of testosterone use, but have not used for at least 6 months
* Men who are already taking finasteride
* Untreated or inadequately treated hypothyroidism
* Significant history of allergy and/or sensitivity to the drug products or excipients, including sensitivity to testosterone and/or finasteride
* Current use of any medications, herbal, and/or nutritional supplements that can interfere with testosterone level
* Currently receiving treatment with cancer chemotherapy or anti-androgens
* Any contraindication to testosterone therapy or finasteride
* History of luteinizing hormone-releasing hormone antagonist or agonist treatment
* History of clomiphene treatment in 6 months prior to Visit 1
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
1
Evaluation of serum hemoglobin parameters as a function of serum DHT levels
Timeframe: Approximately 2 years
2
Evaluation of serum hematocrit parameters as a function of serum DHT levels
Timeframe: Approximately 2 years
3
Evaluation of serum hormone parameters as a function of serum DHT levels