H-36731: Finasteride in Management of Elevated Red Blood Cells

NCT02548117 | Withdrawn Phase 3

• 1 other identifier: 03-15-40-10
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ERYTHROCYTOSIS

Keywords

Testosterone therapy; erythrocytosis; finasteride

Outcome Measures

Primary Outcomes (3)

• Evaluation of serum hemoglobin parameters as a function of serum DHT levels

  Comparison between the two ARMS will be done to determine if administration of finasteride may prevent elevations in or reduce levels of hemoglobin/hematocrit.

  Approximately 2 years

• Evaluation of serum hematocrit parameters as a function of serum DHT levels

  Comparison between the two ARMS will be done to determine if administration of finasteride may prevent elevations in or reduce levels of hemoglobin/hematocrit.

  Approximately 2 years

• Evaluation of serum hormone parameters as a function of serum DHT levels

  Comparison between the two ARMS will be done to determine if administration of finasteride may prevent elevations in or reduce levels of hemoglobin/hematocrit.

  Approximately 2 years

Study Arms (2)

Finasteride

ACTIVE COMPARATOR

ARM 1 subjects will receive finasteride 5 mg orally daily.

Drug: Finasteride

No Treatment

NO INTERVENTION

The ARM 2 (control group) will not receive any study treatment.

Interventions

Finasteride DRUG

Subjects will take 5 mg finasteride orally every day for about 2 years.

Also known as: Proscar

Finasteride

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Polycythemia

Interventions

Finasteride

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Officials

• Larry I. Lipshultz, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 14, 2015
• Study Start: February 1, 2016
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: December 16, 2019

Record last verified: 2019-12

Locations

US (1)