Prospective, randomized, double blind placebo-controlled trial on the efficacy of growth hormone replacement therapy in adult patients with isolated growth hormone deficiency (PRO ISO-GHD Study) - PRO ISO-GHD Study

Pfizer Pharma GmbH0 sites50 target enrollmentDecember 12, 2007

ConditionsIsolated Adult Growth Hormone Deficiency MedDRA version: 9.1Level: LLTClassification code 10056438Term: Growth hormone deficiency

DrugsGenotropin 5 mg/ml

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Isolated Adult Growth Hormone Deficiency
Sponsor: Pfizer Pharma GmbH
Enrollment: 50
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 12, 2007

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Pfizer Pharma GmbH

Eligibility Criteria

Inclusion Criteria

•1\. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
•2\. Males and females between 18 and 65 years of age.
•3\. Women of childbearing potential must have a negative pregnancy test at entry.
•4\. If female be not of child\-bearing potential (i.e. surgically sterile or postmenopausal for at least one years), or be non\-pregnant and using an acceptable method of birth control (such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner) for at least one month prior to the screening visit if necessary, for the duration of the study period and one month after patients last visit.
•5\. Prior to screening visit, an isolated GH deficiency must be determined either by a previously performed GH stimulation test or the measurement of an IGF\-I value below \-2 SD according to age\- and sex\-adjusted reference data. At participating study site, isolated GH deficiency has to be confirmed by an ITT\-Test (peak GH \= 3 ng/mL respective in patients under 25 years of age \<5ng/mL) at screening visit which has to be carried out no sooner than 12 months after surgery and / or irradiation of pituary adenoma or suprasellar tumors or incident of TBI or SAH.
•6\. Clinical and/or laboratory determination following clinical standard methods defined by Medical Societies for exclusion of ACTH, TSH, and LH, FSH deficiencies. Prolactin deficiency only, if detectable at all, should not be considered.
•7\. Patients with the following clinical diagnoses underlying isolated GHD determined in adulthood: pituitary damage resulting from functioning and non\-functioning pituitary adenoma and / or suprasellar tumors (minimum time span one year between operation and study entry), a history of cranial irradiation, traumatic brain injury (history of trauma with subsequent prolonged hospitalization, minimum one year before entry into study), subarachnoid hemorrhage.
•8\. Patients with a QoL\-AGHDA score of 8 or higher at screening visit.
•9\. Subjects are willing and able to comply with scheduled visits and laboratory tests.
•Are the trial subjects under 18? no

Exclusion Criteria

•1\. Isolated Growth hormone deficiency by childhood onset.
•2\. Women who are pregnant or lactating, or who are planning to become pregnant.
•3\. Severe renal, hepatic or cardiac diseases that cause clinical relevant metabolic changes regarding visceral fat mass or may influence, in the judgment of the investigator, cardiovascular risk factors and anthropometric parameters to be assessed in this study.
•4\. Diabetes mellitus type 1 or 2\.
•5\. Anterior pituitary disease other than described under point 5 of the inclusion criteria.
•6\. BMI \> 35\.
•7\. Active malignancies or in anamnesis within the last 5 years.
•8\. GH treatment during the last 12 months.
•9\. Systemic pharmacological therapy with steroid corticoids for more than one week in the month before study entry, L\-thyroxin, testosterone and oral estrogens other than for contraceptive purpose. Low\-dose sexual hormone substitution for postmenopausal women as well as low\-dose L\-thyroxin for treatment of struma is permitted in case secondary hormone deficiencies are excluded.
•10\. Participation in any other clinical trial with investigational drugs within the past 6 months before the current study begins and/or during study participation.