N/A
N=15
Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT00850564 ↗Enrolled (actual)
15
Serious AEs
7.7%
Results posted
Mar 2011
Primary outcome: Primary: Mean Overnight Growth Hormone — 1.2 mcg/L — p=<0.005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Growth Hormone Releasing Hormone (Tesamorelin) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2010
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 |
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.
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.