H-36731: Finasteride in Management of Elevated Red Blood Cells
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|ClinicalTrials.gov Identifier: NCT02548117|
Recruitment Status : Withdrawn (Funding was not available.)
First Posted : September 14, 2015
Last Update Posted : December 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|ERYTHROCYTOSIS||Drug: Finasteride||Phase 3|
Hypogonadism is becoming an increasingly recognized clinical syndrome affecting millions of men in the United States and globally, and is characterized by symptoms including chronic fatigue, decreased libido and muscle mass, and low serum testosterone level. Treatment of hypogonadism in men typically involves treatment with exogenous testosterone.
However, exogenous testosterone therapy is not without risks, and can cause numerous side effects including high blood pressure, hyperlipidemia, and erythrocytosis, or elevated hematocrit. Adverse effects of erythrocytosis can include an increased risk of developing thromboembolism, and treatment of erythrocytosis involves therapeutic phlebotomy and testosterone dose adjustment, which can decrease the symptomatic benefits of testosterone therapy.
Aghazadeh et al.found that erythrocytosis occurring during testosterone therapy may be related to dihydrotestosterone (DHT) levels. As part of normal physiology, testosterone is converted to DHT via 5-alpha reductase (5AR). DHT is associated with various effects on the body, including stimulation of prostate growth, male pattern baldness, and others. Currently, finasteride, a 5-alpha reductase inhibitor (5ARI), is available as an FDA-approved drug used to treat DHT-related prostate growth and to prevent DHT-related baldness.
Given the positive association between DHT and the increased hematocrit seen in men being treated for hypogonadism with exogenous testosterone, finasteride's effects in preventing the synthesis of DHT may improve or even prevent erythrocytosis in men on testosterone.
The study will be a prospective randomized controlled trial of patients on injectable testosterone therapy. Subjects will be evenly distributed between the control and treatment groups. The treatment groups will receive finasteride and the control groups will not. All subjects will then be followed with blood tests to determine if there are any changes in their hematocrit, testosterone, DHT, and other blood test values.
An interim data analysis will be performed after approximately 150 men (75 treatment and 75 control) are accrued into the study and followed for at least 1 year. Rates of hematocrit elevation and erythrocytosis will be evaluated in finasteride treated and untreated men to determine whether finasteride is having an impact on erythrocytosis rates and whether any unanticipated adverse effects are occurring. Secondary outcomes, including effects on erythropoietin and hepcidin levels, will also be evaluated. Study accrual will continue if there is evidence that finasteride may decrease the incidence of erythrocytosis. The study will be stopped if unacceptable adverse events are identified or if there is no evidence suggesting that finasteride mitigates the risk of erythrocytosis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||H-36371: Finasteride as a Method of Managing Testosterone-Induced Erythrocytosis|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Active Comparator: Finasteride
ARM 1 subjects will receive finasteride 5 mg orally daily.
Subjects will take 5 mg finasteride orally every day for about 2 years.
Other Name: Proscar
No Intervention: No Treatment
The ARM 2 (control group) will not receive any study treatment.
- Evaluation of serum hemoglobin parameters as a function of serum DHT levels [ Time Frame: Approximately 2 years ]Comparison between the two ARMS will be done to determine if administration of finasteride may prevent elevations in or reduce levels of hemoglobin/hematocrit.
- Evaluation of serum hematocrit parameters as a function of serum DHT levels [ Time Frame: Approximately 2 years ]Comparison between the two ARMS will be done to determine if administration of finasteride may prevent elevations in or reduce levels of hemoglobin/hematocrit.
- Evaluation of serum hormone parameters as a function of serum DHT levels [ Time Frame: Approximately 2 years ]Comparison between the two ARMS will be done to determine if administration of finasteride may prevent elevations in or reduce levels of hemoglobin/hematocrit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548117
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Larry I. Lipshultz, MD||Baylor College of Medicine|