N/A
Completed N=15
Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
Healthy Volunteers
Source: ClinicalTrials.gov NCT00850564 ↗
Enrolled (actual)
15
Serious AEs
7.7%
Results posted
Mar 2011
Primary outcomePrimary: Mean Overnight Growth Hormone — 1.2 mcg/L — p=<0.005
Summary
The purpose of this trial is to examine the short-term effects of Growth Hormone Releasing Hormone (GHRH, tesamorelin) administration in healthy men. We hypothesize that GHRH will increase GH pulse height and will not affect insulin sensitivity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Overnight Growth Hormone |
1.2 | <0.005 sig |
| SECONDARY Insulin Stimulated Glucose Utilization |
7.5 | 0.61 |
Eligibility Criteria
Inclusion Criteria
- Men aged 18-60 years
- BMI > 20kg/m2 and 126 mg/dL, SGOT > 2.5 times ULN, Hgb 1.4 mg/dL
- Carpal tunnel syndrome
- Severe chronic illness or active malignancy or history of pituitary malignancy or history of colon cancer
- For men, history of prostate cancer or evidence of prostate malignancy by PSA > 5 ng/mL
- Prior history of hypopituitarism, head irradiation or any other condition known to affect the GH axis
- Weight < 110 lbs.
Data sourced from ClinicalTrials.gov (NCT00850564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.