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Male HypogonadismPhase 2NCT00475501

5-Alpha Reductase and Anabolic Effects of Testosterone

A Phase 2 study testing Testosterone Enanthate and Finasteride in people with Male Hypogonadism and Muscle Atrophy, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Male Hypogonadism, Muscle Atrophy, Sarcopenia
What is being tested?
Testosterone Enanthate and Finasteride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
Jan 2007to Oct 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age > 60 years males
  • Primary care at the Malcolm Randall VA Medical Center in Gainesville, Florida.
  • Consenting subjects who have a morning (between 6:00 AM and 10:00 AM) serum total testosterone 300 ng/dL or bioavailable testosterone concentration 70 ng/dL and no exclusion criteria will be randomized to receive either testosterone or placebo.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • North Florida/South Georgia Veterans Health System

    Gainesville, Florida, 32608

Other trials in United States

About this study

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.

Read the detailed description

Approximately 40% of older male veterans have a low serum testosterone concentration. The latter is associated with diminished muscle strength and bone mineral density, depressed mood, low pain tolerance, frailty, and increased mortality. Replacement doses of testosterone have been administered to hypogonadal men for the purpose of reversing deficits in muscle and bone. Although testosterone is clearly important for maintaining muscle and bone in men, there are problems associated with T replacement. First, testosterone causes a number of undesired effects, including fluid retention, gynecomastia, worsening of sleep apnea, polycythemia, prostate enlargement and acceleration of early-stage prostate cancer. The anabolic effects obtained to date from testosterone replacement have been relatively modest, especially in older men. Our hypothesis is that combined treatment with a higher-than-replacement dose of testosterone and a 5- reductase inhibitor will produce substantial anabolic effects, while preventing testosterone-induced prostate enlargement and possibly other adverse effects.

We plan to investigate the efficacy and safety of combined treatment with testosterone and finasteride in older hypogonadal male veterans by conducting a 12-month randomized, placebo-controlled trial. We will administer a higher-than-replacement dose of testosterone plus the 5- reductase inhibitor finasteride to a group of hypogonadal, but otherwise healthy older men. We will determine whether this treatment is a safe and effective means to increase muscle mass and strength. Men aged 60 to 80, with circulating total testosterone 300 ng/dL or bioavailable testosterone 70 ng/dL, will be treated with 125 mg testosterone enanthate/week 5 mg finasteride/day for 1 year. We will assess the effects on body composition, 1- repetition maximum (1-RM) strength, grip strength, functional reach, bone mineral density, mood, cognition, hematopoiesis and prostate volume. We have chosen a moderately high dose of testosterone that may cause some adverse effects. We predict that finasteride will not block the anabolic effects of testosterone, but will block any prostate enlargement or symptoms and possibly other adverse effects as well.

Being tested
Testosterone Enanthate, Finasteride, Placebo
Keywords
anabolic effects, finasteride, male hypogonadism, sarcopenia, testosterone
Medical subject headings
Eunuchism, Muscular Atrophy, Sarcopenia, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Testosterone EnanthateDrug

    Also called Delatestryl

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

  • FinasterideDrug

    Also called Proscar

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

  • PlaceboOther

    Placebo

Study groups in NCT00475501
Study groupRoleWhat they receive
Arm 1Experimentaltestosterone enanthate
Receives: Drug: Testosterone Enanthate
Arm 2Experimentalfinasteride
Receives: Drug: Finasteride
Arm 3Experimentaltestosterone enanthate + finasteride
Receives: Drug: Testosterone Enanthate; Drug: Finasteride
Arm 4Placebo comparatorplacebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline, 3 months, 6 months, 9 months, 12 months

Secondary outcomes (10)

  1. Grip Strength kg

    Grip strength in the dominant arm will be measured by using a dynamometer. Testing will be performed at baseline, after 3, 6, 9 and 12 months of treatment.

    Measured: baseline, 3 months, 6 months, 9 months, 12 months

  2. Lumbar Spine L2-L4 Bone Mineral Density

    Dual x-ray absorptiometry (DXA): We will assess bone mineral density (BMD) and body composition using a fan-bean densitometer (Lunar Prodigy, General Electric Medical Systems).

    Measured: baseline, 12 months

  3. Geriatric Depression Scale

    Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment.

    The minimum score is 0 = no depressive symptoms The maximum score is 15 = a very high level of depressive symptoms

    Measured: baseline, 3 months, 6 months, 9 months, 12 months

  4. 30 Minute Recall Portion of Rey Osterrieth Complex Figure (ROCF) Test

    Rey Osterrieth Complex Figure (ROCF) test is a widely used standardized neuropsychological test for assessing visuospatial constructional functions, visuographic memory, and some aspects of planning.

    The drawing is scored by a blinded neuropsychologist on a scale of 0 to 30 with 30 representing a perfect drawing.

    Measured: baseline, 3 months, 6 months, 9 months, 12 months

  5. Trail-Making Test, Part A

    Trail-Making Test, Part A: is a standardized test of cognitive function which specifically assesses working memory, visual processing, visual spatial skills, selective and divided attention, and psychomotor coordination. the test is scored as seconds required to successful completion of the task with a lower score representing better performance. The mean score on test is 30.75 second with a standard deviation of 16.27.

    Measured: baseline, 3 months, 6 months, 9 months, 12 months

  6. Benton Judgment of Line Orientation Test

    Benton Judgment of Line Orientation Test is a standardized test with 30 items that is specific for visual spatial cognition. Tests will be administered at baseline, after 3, 6, 9 and 12 months of treatment.

    The minimum score is 0, indicating low visual spatial cognition. The maximum score is 30, indicating high visual spatial cognition

    Measured: baseline, 3 months, 6 months, 9 months, 12 months

  7. Hematocrit

    Hematocrit was assessed as a part of routine blood analysis at the indicated time points.

    Measured: baseline, 3 months, 6 months, 9 months, 12 months

  8. Dietary Protein Intake

    Dietary protein intake will be assessed using a 3-day food log and subjects will be counseled to increase protein intake if needed using the guide "Healthy Ways to Eat More Protein".

    Measured: baseline, 3 months, 6 months, 9 months, 12 months

  9. Transrectal Ultrasound Sizing of Prostate

    Transrectal ultrasound sizing of prostate will be performed using the B\&K Diagnostic System 3535, with 7 mega hertz transrectal probe at baseline and after 6 and 12 months of treatment.

    Measured: baseline, 6 month, 12 months

  10. Life Satisfaction

    Life Satisfaction: is a written test of psychological well-being that will be performed at baseline, after 3, 6, 9 and 12 months of treatment. This is a 20-point scale, with a possible range of scores from 0 to 20. A higher score represents greater life satisfaction.

    Measured: baseline, 3 months, 6 months, 9 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionMar 2012
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00475501
Sponsor's protocol ID
ENDA-014-05F
Other IDs
VA Merit Award
Status last verified
Sep 2018
First submitted
16 Apr 2007
Last updated
11 Oct 2018
Data monitoring committee
No

Publications

  • 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.

    PubMed 24012740

  • 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.

    PubMed 24326421

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Testosterone Enanthate and Finasteride in people with Male Hypogonadism and Muscle Atrophy, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1 Repetition Maximum (1-RM) Strength Testing (time frame: baseline, 3 months, 6 months, 9 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00475501, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.

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