Cycled Testosterone Replacement Study

NCT00957528 | Completed Phase 1 Results

• 3 other identifiers: 01-302GCRC 615R01AG022023
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether testosterone (male hormone) therapy is effective if administered in a cyclic fashion (periodic dosing) compared to continuous dosing in men aged 60 to 85 years. Effectiveness will be determined based on improvements in body composition, muscle metabolism, muscle strength, and bone metabolism.

Conditions

Hypogonadism

Keywords

Low Normal Testosterone; Male; Aging

Outcome Measures

Primary Outcomes (3)

• Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months

  The fractional synthetic rate (FSR) of mixed muscle is calculated by directly measuring the incorporation of L-\[ring-13C6\]-phenylalanine into protein (%/hr),, using the precursor-product model: FSR = \[(EP2 - EP1)/(EM•t)\]•60•100, where EP1 and EP2 are the enrichments of bound L-\[ring-13C6\]-phenylalanine in the first and second muscle biopsies, t is the time interval (min) between biopsies, and EM is the mean L-\[ring-13C6\]-phenylalanine enrichment in the muscle intracellular pool.

  5 Months

• Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months

  Maximum weight (pounds) lifted using Cybex weight machine in a single effort(1-RM) for upper extremities (biceps and triceps) and lower extremities quadriceps and hamstrings).

  5 months

• Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA)

  Lean body mass is expressed in grams as calculated by Hologic DEXA.

  5 months

Secondary Outcomes (3)

• Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA)

  5 months

• Changes in Serum Markers of Bone Turnover.

  5 months

• 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines

  5 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Weekly placebo treatment for a duration of 5 months.

Drug: Placebo

Monthly Cycled Testosterone

EXPERIMENTAL

A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.

Drug: Testosterone; Drug: Placebo

Continuous Testosterone

EXPERIMENTAL

Weekly testosterone treatment for a duration of 5 months

Drug: Testosterone

Interventions

Testosterone DRUG

Weekly im injections of 100 mg testosterone enanthate.

Also known as: Testosterone Enanthate

Continuous Testosterone; Monthly Cycled Testosterone

Placebo DRUG

Weekly IM injections of sesame oil.

Also known as: Sesame Oil

Monthly Cycled Testosterone; Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Availability of transportation (i.e., subjects must be able to provide their own transportation to UTMB).

You may not qualify if:

• Medications such as anticoagulants (Coumadin) and glucocorticoids.
• History of angina that occurs with exertion or at rest.
• History of myocardial infarction within the last 12 months.
• Failure to successfully complete an exercise stress test using the Bruce protocol. Subjects that demonstrate ≥ 0.1 mV horizontal or downsloping ST segment depression, a drop in systolic blood pressure of ≥ 10 mm Hg, and/or frequent or repetitive arrhythmias (defined as ≥ 10 PVC/min, or couplets) during the stress test will be excluded.
• LDL cholesterol above 200 mg/dL.
• History of prostatic cancer.
• Elevated prostate specific antigen (PSA) above 4.0 µg/L, or severe benign prostatic hypertrophy (BPH) by history (frequent urination, reduced stream).
• Serum total testosterone concentrations of greater than 500 ng/dL.
• Subjects who engage in high intensity, elite training on a regular basis.
• Major medical illness such as diabetes, chronic obstructive pulmonary disease, or sleep apnea.
• Recent history of smoking tobacco.
• Hematocrit greater than 51%.
• Morbidly obese older men (BMI \> 35).
• Hypertension: Blood pressure on three consecutive measurements taken at one week intervals that has a systolic pressure ≥ 140 or a diastolic blood pressure ≥ 90. Subjects will be included if they are on two or less blood pressure medications and have a blood pressure below these criteria.
• History of hepatitis or a 3-fold elevation of liver function tests (Alk phos, ALT, AST).

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone; testosterone enanthate; Sesame Oil

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Randall Urban, M.D., Professor of Medicine
• Organization: The University of Texas Medical Branch at Galveston

rurban@utmb.edu

409- 772-1176

Study Officials

• Randall J Urban, M.D.

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2009
• First Posted: August 12, 2009
• Study Start: January 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 10, 2012
• Results First Posted: August 21, 2012

Record last verified: 2012-09

Locations

US (1)