Decreased Testosterone Levels in Men Over 65

Condition(s) targeted: Aging; Hypogonadism; Andropause

Intervention: Anastrozole (Drug); Testosterone Gel (Drug); Placebo tablet (Drug); Placebo gel (Drug); Calcium Cardone 500mg with vitamin D 400 IU (Dietary Supplement)

Phase: Phase 3

Status: Recruiting

Sponsored by: National Institute on Aging (NIA)

Official(s) and/or principal investigator(s):
Josephine M Egan, MD, Principal Investigator, Affiliation: Chief, Diabetes Section, LCI/NIA/NIH

Overall contact:
Denise Melvin, Phone: 410-350-3924, Email: melvinde@grc.nia.nih.gov

The purpose of this study is to determine if an aromatase inhibitor (a drug that inhibits the conversion of testosterone to estrogen) is as effective as testosterone replacement in improving muscle mass, muscle strength, sexual function, memory, and bone health.

Official title: The Effects of Aromatase Inhibition on Sex Steroids, Pituitary Hormones, Markers of Bone Turnover, Muscle Strength and Cognition on Older Men

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Improvements in bone quality, muscle strength, cardiac function, cognition, sexual and overall well-being

Urinary symptoms

Glucose tolerance

Blood lab values

Detailed description: Approximately 20% of men over the age of 70 have low testosterone levels. In some studies, testosterone replacement has resulted in improvement in bone mass, muscle strength, quality of life and memory function. In the body, testosterone is converted into estrogen. Hence, it is unclear whether these beneficial effects are due to testosterone or estrogen. Research has shown that inhibition of estrogen production in men results in an increase in testosterone levels.

In this study, patients will be assigned to one of three groups: one group will receive testosterone gel and a placebo tablet, one group will receive a 1mg Anastrozole tablet and a placebo gel, and one group will receive a placebo tablet and placebo gel. Each group will receive a daily dose of calcium with vitamin D. The study requires 6 visits over a 12-month period for testing and evaluation. Two of the 6 visits will require an overnight stay in the hospital so that an intravenous (IV) line can be placed in the arm to allow samples to be drawn throughout the night. Testing will include a cardiac stress test, a glucose tolerance test, bone and muscle tests, evaluation of memory function, etc. For the safety of the prostate, we will perform a prostate ultrasound at the start and end of the study and we will monitor urinary symptoms, prostate specific antigen (PSA) levels and the prostate exam throughout the study.

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Male

- 65 years of age or older

- Testosterone level less than 350 ng/dl (we will check this level at the screening

visit)

- Able to complete an informed consent

Exclusion Criteria:

- History of Stroke

- History of Dementia

- History of Diabetes

- Blood Pressure at rest of > 155/90 mm Hg

- Chronic medical condition (i. e. heart failure, rheumatoid arthritis)

- On osteoporosis medications

- On steroids (prednisone, cortisone)

- History of gastric surgery

- History of any Cancer (except non-melanoma skin cancers)

- Drink more than 2 beers OR 1 glass of wine or cocktail daily

- Smoke any tobacco product

- Started a new medication within the past three months

- History of joint replacement

Denise Melvin, Phone: 410-350-3924, Email: melvinde@grc.nia.nih.gov

National Institute on Aging (NIA), Harbor Hospital, Baltimore, Maryland 21225, United States; Recruiting
Denise Melvin, Study Coordinator, Phone: 410-350-3924 or 800-225-2572, Ext: 3924, Email: melvinde@grc.nia.nih.gov
NIA Recruiter, Phone: 410-350-3941, Email: NIAStudiesRecruitment@mail.nih.gov
Shehzad Basaria, MD, Sub-Investigator

Related publications:

Gray A, Feldman HA, McKinlay JB, Longcope C. Age, disease, and changing sex hormone levels in middle-aged men: results of the Massachusetts Male Aging Study. J Clin Endocrinol Metab. 1991 Nov;73(5):1016-25.

Purifoy FE, Koopmans LH, Mayes DM. Age differences in serum androgen levels in normal adult males. Hum Biol. 1981 Dec;53(4):499-511. No abstract available.

Vermeulen A. Clinical review 24: Androgens in the aging male. J Clin Endocrinol Metab. 1991 Aug;73(2):221-4. Review. No abstract available.

Morley JE, Kaiser FE, Perry HM 3rd, Patrick P, Morley PM, Stauber PM, Vellas B, Baumgartner RN, Garry PJ. Longitudinal changes in testosterone, luteinizing hormone, and follicle-stimulating hormone in healthy older men. Metabolism. 1997 Apr;46(4):410-3.

Starting date: August 2004
Ending date: May 2011
Last updated: August 19, 2008