Last updated on July 2018

Cardiovascular Outcomes of Low Testosterone

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hypogonadism
  • Age: Between 18 - 75 Years
  • Gender: Male

Inclusion Criteria:

  1. Men aged 18-40 years and 50-75 years
  2. Chronically low testosterone group will have testosterone concentrations <300 ng/dl, and young and older normal testosterone groups will have testosterone levels 400-1000 ng/dl
  3. No use of sex hormones for at least 1 year
  4. Body mass index <35 kg/m2
  5. Nonsmokers
  6. Resting blood pressure <160/90 mmHg
  7. Fasting plasma glucose <126 mg/dL
  8. Healthy, as determined by medical history, physical examination, standard blood chemistries (chemistry panel, complete blood clot and circulating thyroid levels) and a graded exercise stress test with monitoring of blood pressure and electrocardiogram (ECG)
  9. Sedentary or recreationally active (< 3 days/wk of vigorous aerobic exercise)
  10. No use of medications that might influence cardiovascular function including anti-hypertensive, lipid lowering medications, and corticosteroids
  11. No use of vitamin supplements or anti-inflammatory medications, or willing to stop 1 month prior and throughout the study.

Exclusion Criteria:

  1. Contraindications to:
  2. Gonadotropin releasing hormone (GnRH) antagonist
  3. Testosterone gel and aromatase inhibitor including hypersensitivity to Acyline, Androgel, Arimidex
  4. Extrinsic peptide hormones, mannitol, GnRH or any other GnRH analogs
  5. History of or active prostate or breast cancer or other sex hormone-dependent neoplasms
  6. Pre-existing or active cardiac, renal or hepatic disease
  7. History of stomach ulcer or bleeding
  8. History of epilepsy or other seizure disorder
  9. Diabetes
  10. Active infection
  11. Disease that affects the nervous system
  12. Abnormal resting ECG

Additionally, men participating in the gonadal suppression intervention study will do so with the understanding that they will be randomly assigned to study groups that involve either GnRH antagonist plus testosterone gel plus placebo tablet (33% chance), GnRH antagonist plus testosterone gel plus aromatase inhibitor tablet (33% chance) or GnRH antagonist plus placebo gel plus placebo tablet (33% chance).

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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