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Growth hormone infusions tested for immune boost in healthy men

NCT ID NCT00663611

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 12 times

Summary

This completed Phase 1 study tested whether giving growth hormone (Norditropin) through a small pump under the skin could improve immune function in healthy men aged 25 to 50. Participants received either growth hormone or a placebo for up to 4 weeks, with frequent blood and urine tests to monitor effects. The goal was to see if growth hormone can reverse age-related immune decline, but results are not yet available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Norditropin (somatropin, a synthetic growth hormone)
What this could lead to
If successful, this study could point toward ways to boost immune function in older adults or those with weakened immune systems.
What could go wrong
This is an early Phase 1 study in healthy men only, so results may not apply to women, older people, or those with illnesses. The study is completed, but no clear outcomes are reported yet.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

66 people

The number who actually took part.

Start date

Oct 2006

Finished

Oct 2014

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 50 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: 1. Healthy men only (There is a gender difference in GH response with adult females requiring on average twice the GH dose for similar effects. In order to eliminate gender difference as a confounding factor in this study, we are studying male subjects only because the GH dose requirement is lower.) 2. Age 25-50 (Age restriction is used to remove age as a confounding factor because GH and thymic function are known to decrease with age.) 3. Screening laboratory evaluations with no clinically significant abnormal results (minor deviations from "normal" lab results will be at the discretion of the principal investigator): 1. fasting comprehensive metabolic panel 2. complete blood count with differential and platelets 3. 75-gram oral glucose tolerance test (OGTT) * fasting plasma glucose (FPG) \< 100 mg/dL * 2-hr OGTT \< 140 mg/dL 4. Insulin-like growth factor-I (IGF-I) 5. thyroid function test (TSH, free T3, free T4) 6. fasting lipid profile 4. BMI \< 30 (Men with BMI \>= 30 are excluded because decrease in GH secretion and clearance has been shown in obesity.) 5. Have NOT participated in another clinical trial involving any pharmacologic agents within the past 60 days 6. Able to complete an inform consent 7. Agree to not participate in other clinical trials within the study period EXCLUSION CRITERIA: 1. Women 2. FPG \>= 100 mg/dL or 2-hour OGTT \>= 140 mg/dL 3. Abnormal electrocardiogram (EKG) suggesting possible underlying cardiac conditions that, in the opinion of the investigator(s), may cause participation of the subject in the study unsafe 4. Positive stool guaiac 5. Evidence of illicit drug use 6. History of smoking any tobacco products within one year prior to screening 7. Alcohol intake \> 30 grams (drink more than 2 beers per day OR equivalent amount of alcohol) 8. History of Human Immunodeficiency Virus (HIV) infection 9. History of active or chronic Hepatitis B and/or C infection 10. History of malignancy 11. History of coronary disease 12. History of seizures or other neurologic diseases 13. History of liver or renal diseases 14. History of gastrointestinal or endocrine disorders 15. History of glucocorticoid use (over one month) or other immunosuppressive agents (any) 16. unable to undergo a magnetic resonance imaging (MRI) procedure 17. Any medical history that, in the opinion of the investigator(s), will make participation of the subject in the study unsafe

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • National Institute of Aging, Clinical Research Unit

    Baltimore, Maryland, 21224, United States

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