Decreased Testosterone Levels in Men Over 65 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Aging Hypogonadism Andropause	Drug: Anastrozole Drug: Testosterone Gel Drug: Placebo tablet Drug: Placebo gel Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU	Phase III

MedlinePlus related topics:

Memory

ChemIDplus related topics:

Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate Anastrozole Calcium gluconate Vitamin D Ergocalciferol Dextrose

U.S. FDA Resources

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

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

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

Improvements in bone quality, muscle strength, cardiac function, cognition, sexual and overall well-being [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Urinary symptoms [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Glucose tolerance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Blood lab values [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	75
Study Start Date:	August 2004
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 25 participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months	Drug: Testosterone Gel 5.0 - 7.5 mg gel daily for 12 months Drug: Placebo tablet Daily for 12 months Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU 1 tablet three times a day
2: Experimental 25 participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months	Drug: Anastrozole 1 mg tablet daily for 12 months Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU 1 tablet three times a day
3: Placebo Comparator 25 participants will receive a placebo tablet and placebo gel daily for 12 months	Drug: Placebo tablet Daily for 12 months Drug: Placebo gel Daily for 12 months Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU 1 tablet three times a day

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.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104572

Contacts


Contact: Denise Melvin	410-350-3924	melvinde@grc.nia.nih.gov

Locations


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

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators


Principal Investigator:	Josephine M Egan, MD	Chief, Diabetes Section, LCI/NIA/NIH

More Information

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.

Responsible Party:	National Institute on Aging ( Josephine Egan, MD, Principal Investigator )
Study ID Numbers:	AG0018
First Received:	March 1, 2005
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00104572
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Low testosterone level

glucose tolerance

estrogen

bone density

quality of life

memory function

sarcopenia

Study placed in the following topic categories:

Testosterone

Anastrozole

Vitamin D

Hypogonadism

Gonadal Disorders

Ergocalciferols

Quality of Life

Endocrine System Diseases

Methyltestosterone

Endocrinopathy

Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Anabolic Agents

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Enzyme Inhibitors

Aromatase Inhibitors

Hormones

Pharmacologic Actions

Androgens

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00104572