Trial Outcomes & Findings for Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men (NCT NCT00850564)

Results Overview

Outcome is mean overnight growth hormone at 2 weeks (i.e., following 2 weeks of treatment with growth hormone releasing hormone). Growth hormone was measured overnight (from 8pm-7:40am) by frequent blood sampling, and the mean is the average of these frequent measurements. The mean measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the mean measurement before treatment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

at 2 weeks (i.e., after 2 weeks of treatment)

Results posted on

2011-04-19

Participant Flow

recruitment from March 2009 through March 2010

Participant milestones

Participant milestones
Measure	Growth Hormone Releasing Hormone (Tesamorelin) Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Growth Hormone Releasing Hormone (Tesamorelin) Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Growth Hormone Releasing Hormone (Tesamorelin) n=15 Participants Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	44 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: at 2 weeks (i.e., after 2 weeks of treatment)

Population: analysis of 13 participants who completed both baseline and 2 week visits

Outcome is mean overnight growth hormone at 2 weeks (i.e., following 2 weeks of treatment with growth hormone releasing hormone). Growth hormone was measured overnight (from 8pm-7:40am) by frequent blood sampling, and the mean is the average of these frequent measurements. The mean measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the mean measurement before treatment.

Outcome measures

Outcome measures
Measure	Growth Hormone Releasing Hormone (Tesamorelin) n=13 Participants Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
Mean Overnight Growth Hormone	1.2 mcg/L Standard Error 0.3

SECONDARY outcome

Timeframe: at 2 weeks (i.e., after 2 weeks of treatment)

Insulin stimulated glucose uptake (M) is the amount of glucose (measured in mg per kg body weight per minute) taken up during the steady state period of a euglycemic hyperinsulinemic clamp. This measure was calculated for minutes 100-120 of euglycemic hyperinsulinemic clamp procedure at 2 weeks (i.e., after 2 weeks treatment with growth hormone releasing hormone). The measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the measurement before treatment.

Outcome measures

Outcome measures
Measure	Growth Hormone Releasing Hormone (Tesamorelin) n=13 Participants Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
Insulin Stimulated Glucose Utilization	7.5 mg/kg/min Standard Error 1.2

Adverse Events

Growth Hormone Releasing Hormone (Tesamorelin)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Growth Hormone Releasing Hormone (Tesamorelin) n=13 participants at risk Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
Infections and infestations Influenza due to Influenza A virus	7.7% 1/13 • Number of events 1 • Total of 4 weeks: 2 weeks of treatment with study drug, followed by 2 weeks off drug Subjects queried about potential side effects at 2 week visit (after 2 weeks on study drug) and at 4 week visit (after 2 weeks off drug)

Other adverse events

Other adverse events
Measure	Growth Hormone Releasing Hormone (Tesamorelin) n=13 participants at risk Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
Cardiac disorders chest pain	7.7% 1/13 • Number of events 1 • Total of 4 weeks: 2 weeks of treatment with study drug, followed by 2 weeks off drug Subjects queried about potential side effects at 2 week visit (after 2 weeks on study drug) and at 4 week visit (after 2 weeks off drug)
Skin and subcutaneous tissue disorders rash	7.7% 1/13 • Number of events 1 • Total of 4 weeks: 2 weeks of treatment with study drug, followed by 2 weeks off drug Subjects queried about potential side effects at 2 week visit (after 2 weeks on study drug) and at 4 week visit (after 2 weeks off drug)
Gastrointestinal disorders Diarrhea	7.7% 1/13 • Number of events 2 • Total of 4 weeks: 2 weeks of treatment with study drug, followed by 2 weeks off drug Subjects queried about potential side effects at 2 week visit (after 2 weeks on study drug) and at 4 week visit (after 2 weeks off drug)
Nervous system disorders Headache	7.7% 1/13 • Number of events 2 • Total of 4 weeks: 2 weeks of treatment with study drug, followed by 2 weeks off drug Subjects queried about potential side effects at 2 week visit (after 2 weeks on study drug) and at 4 week visit (after 2 weeks off drug)
Skin and subcutaneous tissue disorders Complaining of itching	7.7% 1/13 • Number of events 1 • Total of 4 weeks: 2 weeks of treatment with study drug, followed by 2 weeks off drug Subjects queried about potential side effects at 2 week visit (after 2 weeks on study drug) and at 4 week visit (after 2 weeks off drug)
Nervous system disorders Dizziness	7.7% 1/13 • Number of events 1 • Total of 4 weeks: 2 weeks of treatment with study drug, followed by 2 weeks off drug Subjects queried about potential side effects at 2 week visit (after 2 weeks on study drug) and at 4 week visit (after 2 weeks off drug)
Skin and subcutaneous tissue disorders Burn of back	7.7% 1/13 • Number of events 1 • Total of 4 weeks: 2 weeks of treatment with study drug, followed by 2 weeks off drug Subjects queried about potential side effects at 2 week visit (after 2 weeks on study drug) and at 4 week visit (after 2 weeks off drug)

Additional Information

Steven Grinspoon, MD

Massachusetts General Hospital

Phone: 617-724-9109

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60