GoldBamboo.com - Knowledge is strong medicine
  

Decreased Testosterone Levels in Men over 65 - Article


  Not Signed In - Sign In / Register


Get Your Free Credit Report Right Now!

Zip Code:






Testosterone Transdermal

Androderm; Testoderm; Testoderm TTS 




Clinical Trial: Decreased Testosterone Levels in Men over 65

This study is currently recruiting patients.

Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)

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 Treatment or Intervention Phase
Aging
Hypogonadism
Andropause
 Drug: Anastrozole
 Drug: Testosterone Gel
Phase III

MedlinePlus related topics:  Endocrine Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, 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: 
Primary Outcomes: Improvements in bone quality, muscle strength, cardiac function, cognition, sexual and overall well-being; Urinary symptoms; Glucose tolerance; Blood lab values
Expected Total Enrollment:  75

Study start: August 2004;  Expected completion: February 2007

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 testoterone 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 above,  Genders Eligible for Study:  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

Location and Contact Information

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

Maryland
      National Institute on Aging (NIA), Harbor Hospital, Baltimore,  Maryland,  21225,  United States; Recruiting
Denise Melvin, Study Coordinator  410-350-3924 or 800-225-2572  Ext. 3924    melvinde@grc.nia.nih.gov 
Sara Betkey, Participant Recruitment  410-350-3941 or 800-225-2572  Ext. 3941    betkeys@grc.nia.nih.gov 
Shehzad Basaria, MD,  Sub-Investigator

Study chairs or principal investigators

Josephine M Egan, MD,  Principal Investigator,  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.

Study ID Numbers:  AG0018
Record last reviewed:  March 2005
Last Updated:  March 1, 2005
Record first received:  March 1, 2005
ClinicalTrials.gov Identifier:  NCT00104572
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources



[ Disclaimer: The information on GoldBamboo for any particular treatment, medicine, drug, or herbal product might be missing or incomplete, and should never be used as a single source of knowledge. GoldBamboo generally has links to authoritative sites displayed toward the bottom of each topic page under the heading "Resources". ]

Take control over your directory listings...INSTANTLY

Every day, thousands of users find businesses like yours in the GoldBamboo directory.

Limited Time Offer!!!

For only $30 a year, a savings of 70% off our standard rate:

  • Edit your listing (whenever you want!)
  • Link to your website
  • Choose which categories you are listed in
  • Describe your services

The process will take only a few minutes and consists of 3 easy steps:

1. Register     >     2. Edit Listings     >     3. Publish

Your Company
your street
yourtown, YS 12345
888-888-8888



No Thanks

Popular Treatments

Acne Treatment ADHD Treatment Allergy Treatment Alzheimer's Treatment
Anemia Treatment Arthritis Treatment Asthma Treatment Bipolar Disorder Treatment
Bird Flu Treatment Bladder Cancer Treatment Bladder Control Treatment Blood Pressure Treatment
Brain Tumor Treatment Breast Cancer Treatment Bronchitis Treatment Cancer Treatment
Cancer Alternative Treatment Cataract Treatment Cirrhosis Treatment Colitis Treatment
Colon Cancer Treatment Common Cold Treatment Conjunctivitis Treatment Constipation Treatment
Crohn's Disease Treatment Cystic Fibrosis Treatment Depression Treatment Dermatitis Treatment
Diabetes Treatment Edema Treatment Epilepsy Treatment Erectile Dysfunction Treatment
Fibromyalgia Treatment GERD Treatment Glaucoma Treatment Gout Treatment
Hay Fever Treatment Headache Treatment Heart Disease Treatment Hepatitis Treatment
High Blood Pressure Treatment High Cholesterol Treatment Hives Treatment Hypertension Treatment
Hypoglycemia Treatment IBS Treatment Impotence Treatment Indigestion Treatment
Infertility Treatment Influenza Treatment Insomnia Treatment Lactose Intolerance Treatment
Leukemia Treatment Lung Cancer Treatment Lyme Disease Treatment Macular Degeneration Treatment
Menopause Treatment Migraine Treatment Osteoarthritis Treatment Osteoporosis Treatment
Pancreatic Cancer Treatment PMS Treatment Pneumonia Treatment Prostate Diseases Treatment
Restless Leg Treatment Rheumatoid Arthritis Treatment Sepsis Treatment Sinusitis Treatment
Skin Cancer Treatment Sleep Apnea Treatment Snoring Treatment Stroke Treatment
Testicular Cancer Treatment
GoldBambooTM

Your Integrative Health and Wellness Resource for Testosterone Transdermal.

November 25, 2009



Page Updated: June 1, 2005
============== Advertisement ==============
Disclaimer: All material displayed on the GoldBamboo.com website is provided for educational purposes only. Consult a physician regarding the applicability of any information found on GoldBamboo.com to your symptoms or medical condition.

Home | About Us | Link To Us | Feedback | Disclaimer | Privacy Policy | Terms of Use | Health Forums

Copyright © 2004-2009 - Anaconda Partners LLC - All rights reserved.

HONcode accreditation seal.

We comply with the HONcode standard for health trust worthy information:
verify here.