5-Alpha Reductase and Anabolic Effects of Testosterone

NCT00475501 | Completed Phase 2 Results

• 2 other identifiers: ENDA-014-05FVA Merit Award
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a higher-than-replacement dose of testosterone and finasteride can be combined to safely increase muscle strength in older men who have a low blood concentration of testosterone.

Conditions

Male Hypogonadism; Muscle Atrophy; Sarcopenia; Benign Prostate Hypertrophy

Keywords

anabolic effects; finasteride; male hypogonadism; sarcopenia; testosterone

Outcome Measures

Primary Outcomes (1)

• 1 Repetition Maximum (1-RM) Strength Testing

  1-RM strength testing for 5 exercises will be performed using dynamic resistance exercise machines. Testing will be performed before treatment (baseline), at 3, 6, 9 and 12 months after treatment.

  baseline, 3 months, 6 months, 9 months, 12 months

Secondary Outcomes (10)

• Grip Strength kg

  baseline, 3 months, 6 months, 9 months, 12 months

• Lumbar Spine L2-L4 Bone Mineral Density

  baseline, 12 months

• Geriatric Depression Scale

  baseline, 3 months, 6 months, 9 months, 12 months

• 30 Minute Recall Portion of Rey Osterrieth Complex Figure (ROCF) Test

  baseline, 3 months, 6 months, 9 months, 12 months

• Trail-Making Test, Part A

  baseline, 3 months, 6 months, 9 months, 12 months

Study Arms (4)

Arm 1

EXPERIMENTAL

testosterone enanthate

Drug: Testosterone Enanthate

Arm 2

EXPERIMENTAL

finasteride

Drug: Finasteride

Arm 3

EXPERIMENTAL

testosterone enanthate + finasteride

Drug: Testosterone Enanthate; Drug: Finasteride

Arm 4

PLACEBO COMPARATOR

placebo

Other: Placebo

Interventions

Testosterone Enanthate DRUG

125 mg, i.m. injection, once/week, for 52 weeks

Also known as: Delatestryl

Arm 1; Arm 3

Finasteride DRUG

5 mg, oral, once/day, for 52 weeks

Also known as: Proscar

Arm 2; Arm 3

Placebo OTHER

Placebo

Arm 4

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 60 years males
• Primary care at the Malcolm Randall VA Medical Center in Gainesville, Florida.

You may not qualify if:

• Subjects with cognitive impairment will be identified by the Mini-Cog test and excluded. The Mini-Cog has high sensitivity and specificity for cognitive impairment, and is not affected by level of education.
• We will also exclude subjects with receptive aphasia, or a contraindication to testosterone replacement (i.e., history of or active prostate or breast cancer, severe benign prostatic hyperplasia as assessed by elevated American Urologic Association Symptom Index (AUASI) score \> 25), congestive heart failure (Class 3 or 4), sleep apnea syndrome, polycythemia (Hct \> 55%), or prostate specific antigen (PSA) \> 2.6 ng/mL) will be excluded.
• Obese subjects (BMI \> 35) will also be excluded.
• Subjects currently receiving testosterone supplementation or subjects who have an allergy to testosterone will also be excluded.
• Subjects previously receiving testosterone replacement therapy must be off such medication for at least four weeks.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Endo Pharmaceuticals: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

Related Publications (2)

• Yarrow JF, Beck DT, Conover CF, Beggs LA, Goldberger BA, Borst SE. Invalidation of a commercially available human 5alpha-dihydrotestosterone immunoassay. Steroids. 2013 Dec 11;78(12-13):1220-5. doi: 10.1016/j.steroids.2013.08.013. Epub 2013 Sep 6.

  PMID: 24012740 RESULT

• Borst SE, Yarrow JF, Conover CF, Nseyo U, Meuleman JR, Lipinska JA, Braith RW, Beck DT, Martin JS, Morrow M, Roessner S, Beggs LA, McCoy SC, Cannady DF 2nd, Shuster JJ. Musculoskeletal and prostate effects of combined testosterone and finasteride administration in older hypogonadal men: a randomized, controlled trial. Am J Physiol Endocrinol Metab. 2014 Feb 15;306(4):E433-42. doi: 10.1152/ajpendo.00592.2013. Epub 2013 Dec 10.

  PMID: 24326421 RESULT

MeSH Terms

Conditions

Eunuchism; Muscular Atrophy; Sarcopenia; Prostatic Hyperplasia

Interventions

testosterone enanthate; Finasteride

Condition Hierarchy (Ancestors)

Hypogonadism; Gonadal Disorders; Endocrine System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Stephen Borst, Ph.D
• Organization: Geriatric Research Education and Clinical Center

stephen.borst@va.gov

352-374-6114

Study Officials

• Stephen Borst, PhD

  North Florida/South Georgia Veterans Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: May 21, 2007
• Study Start: January 1, 2007
• Primary Completion: March 1, 2012
• Study Completion: October 1, 2014
• Last Updated: October 11, 2018
• Results First Posted: July 31, 2014

Record last verified: 2018-09

Locations

US (1)