Overview
Short Stature Related Distress
Status:
Completed
Completed
Trial end date:
2017-11-01
2017-11-01
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
The research aims to provide data on gender-related psychological impact of GH (Growth Hormone)treatment. Implicit measurable psychological metrics of the therapy outcome on males are to be evaluated in a Prospective Randomized Controlled Trial. As a secondary axis of the study, the investigators aim to provide descriptive documentation of the unique distress signal manifestation implicitly shown by Idiopathic Short Stature (ISS) boys and suggest methods of early detection and measurement of such manifestations that can be used to cement guidelines for the treatment in GH.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Rabin Medical CenterCollaborator:
Pfizer
Criteria
Inclusion Criteria:1 Segment 1 :Boys at the age range of 8-13 years 2. Segment 2: Boys at the age range of
12-17 years 3. Tanner stage 1 (segment 1 only) 4. more than 2 SD's (standard deviation)
below the average height
Exclusion Criteria:
1. Mental retardation,
2. Psychiatric illness,
3. Lack of informed consent\assent.
4. Health status that required chronic treatment with steroids