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Sermorelin

GHRH (1-29), GRF 1-29 NH2, Sermorelin acetate

Quick Stats
Studies 223
Trials 41
Completed PHASE3 INTERVENTIONAL NCT01060488

Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The aim of the study is to determine the specificity and sensitivity of the combined growth hormone releasing hormone (GHRH) + Arginine test in healthy volunteers, subjects with highly probable adult growth hormone deficiency (AGHD) and subjects who were probably free of AGHD.

Detailed Description

The randomisation was carried out before the first test was performed. In order to be informed of the subject's randomisation group, the investigator phoned the access number given to him/her. The subject's allocation to a given randomisation arm was determined on the basis of a centralised randomisation (answering service), balanced per group of subjects with a minimisation on 2 criteria: age and BMI. This was a centralised randomisation using a Interactive Voice Response System (IVRS) which was balanced in each of the following 3 categories of subjects: * Category A = healthy volunteers, * Category B = subjects with a strong probability of deficit in GH, * Category C = subjects with a low probability of deficit in GH. In each of these 3 categories, the subjects underwent 3 tests whose sequences were determined by the following randomisation group: * Group 1: GHRH+Arg, GHRH+Arg, ITT or * Group 2: ITT, ITT, GHRH+Arg.

Interventions

Name: GHRH+Arg, GHRH+Arg, ITT
Type: OTHER
Description: GHRH+Arg repeatability test (2 tests) + comparison with one IT test
Name: ITT, ITT, GHRH+Arg.
Type: OTHER
Description: IT repeatability test (2 tests) + comparison with one GHRH+Arg test

Primary Outcomes

Measure: Level of GH peak (recorded following stimulation tests)
TimeFrame: within 120 min after stimulation (blood samples were tacken at T0(before), T15, T30, T45, T60, T90 and T120 min after stimulation).
Description:

Trial Information

NCT ID

NCT01060488

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Merck KGaA, Darmstadt, Germany

Last Updated

December 15, 2025

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