Hormone Treatment in Growth Hormone and Testosterone Deficient Patients

NCT01397500 | Terminated Phase 2

• 1 other identifier: CS/Muenchen 02
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Growth hormone and gonadotropin deficiency after brain injury (traumatic brain injury, ischemic stroke, subarachnoidal hemorrhage): the effects of hormone replacement on cognition, quality of life and body composition Randomized, controlled, 3 arm (group 2: double-blind; groups 1 and 3: open), multi-center, pilot study (Phase II)

Conditions

Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  Quality of Life (QoL) was measured with the following questionnaires prior to treatment and after treatment: * SF-12 short-form health questionnaire (12 items, score: min. 12/max. 47) * QoL-AGHDA Assessment of GHD in Adults (25 items: yes/no answers) * EQ-5 D Euroquol (5 items, scale per items from 1 (no problems) to 3 (severe problems); 1 Likert scale (0 worst-100 best) to measure health status) * BDI Beck Depression Inventory (21 items, score: min. 0/max. 63) * PSQI Pittsburgh Sleep Quality Index: (4 items regarding sleep duration, 11 items regarding sleep quality, 1 item regarding sleeping medication, 2 item regarding daytime dysfunction, 1 item regarding sleeping habit; 5 items for third-party assessment) * QOLIBRI Quality of Life after Brain Injury (37 items, scale per item from 1 (not at all) to 5 (very much) QoL was measured with difference between mean scores of the respective questionnaires, determined before and after treatment.

  6 months

Study Arms (3)

Genotropin

ACTIVE COMPARATOR

6 months Genotropin (open treatment) Daily dose: Male \< 45 years: 0,4 mg; ≥ 45 years: 0,2 mg Female \< 45 years: 0,5 mg; ≥ 45 years: 0,3 mg Starting with half of the dose for the first 4 weeks.

Drug: Genotropin

Testosterone undecannoate

ACTIVE COMPARATOR

18 weeks testosterone undecanoate/placebo (double-blind treatment) 1000 mg/4 ml at baseline and after 6 weeks

Drug: Testosterone undecannoate

control group

NO INTERVENTION

No Intervention.

Interventions

Genotropin DRUG

Genotropin administered sc once a day by patient or caregiver.

Also known as: GH

Genotropin

Testosterone undecannoate DRUG

Testosterone undecannoate administered twice (6 week Interval) im by investigator.

Also known as: Testo

Testosterone undecannoate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group 1:
• Age
• F/M
• Stable phase after TBI, SAH or IS
• Stable substitution of other hormonal axes
• GH below 6 ng/ml after stimulation with ITT or GH below cut-off in GHRH/arginine test using BMI-adjusted cut-off limits, GHRH/arginine test should be done only in patients denying or with a contraindication for ITT
• Written informed consent
• Group 2:
• Age
• PSA in normal range
• Stable phase after TBI, SAH or IS
• Stable substitution of other hormonal axes
• Below 3.5 ng/ml testosterone
• Written informed consent
• Group 3:

You may not qualify if:

• Group 1:
• Pregnancy/lactation period
• Women of childbearing potential not using an adequate method of birth control
• Men not willing to use an adequate method of birth control
• Previous or concomitant medication with GH
• Hypersensitivity to GH
• Drug or alcohol abuse
• Participation in another clinical trial with investigational new drug
• Planned treatment or changes in established treatment with other drug which might significantly influence GH axis or cognitive function
• Non-ability to perform testing
• Presence of other conditions listed in contraindications or warnings in local SPC of GH
• Onset of GH-deficiency before BI
• Group 2:
• Men not willing to use an adequate method of birth control
• Previous or concomitant medication with androgens or anabolic steroids within 12 months

Sponsors & Collaborators

• Max-Planck-Institute of Psychiatry: lead
• Schoen Clinic Bad Aibling: collaborator

Study Sites (1)

Max Planck Institute

Munich, Bavaria, 80804, Germany

Location

Related Publications (1)

• Leonhardt M, Kopczak A, Schapers B, Limbrock J, Samann PG, Czisch M, von Steinbuechel N, Jordan M, Schneider HJ, Schneider M, Sievers C, Stalla GK. Low Prevalence of Isolated Growth Hormone Deficiency in Patients After Brain Injury: Results From a Phase II Pilot Study. Front Endocrinol (Lausanne). 2018 Dec 17;9:723. doi: 10.3389/fendo.2018.00723. eCollection 2018.

  PMID: 30619080 DERIVED

MeSH Terms

Interventions

Human Growth Hormone; testo

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Caroline Sievers, MD

  Max Planck Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2011
• First Posted: July 19, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 11, 2016

Record last verified: 2016-01

Locations

DE (1)