NCT00969644

Brief Summary

Observations in patients with growth hormone (GH)-disturbances have suggested that GH/IGF-I might have anti-inflammatory effects. To elucidate this hypothesis the investigators have planned a study to investigate if 3 weeks administration of GH and subsequently the GH antagonist Pegvisomant (or vice versa) influence serum levels of different inflammatory markers in healthy volunteers.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

September 1, 2009

Status Verified

August 1, 2009

Enrollment Period

6 months

First QC Date

August 31, 2009

Last Update Submit

August 31, 2009

Conditions

Interaction Between the GH/IGF-I System and the Immune-system

Outcome Measures

Primary Outcomes (1)

  • The relationship between changes in serum levels of Tumor Necrosis Factor α (TNF-α), Interleukin-6 (IL-6), high sensitive CRP (hsCRP) and YKL-40 vs. changes in serum levels og IGF-I

    1/9 2009 - 1/3 2010

Study Arms (2)

GH

ACTIVE COMPARATOR
Drug: Somatropin

Pegvisomant

ACTIVE COMPARATOR
Drug: Pegvisomant

Interventions

SomatropinDRUG

s.c injections once daily 10-30 mícrogram/kg/day

GH
PegvisomantDRUG

s.c. injections once daily (10-15 mg/day)

Pegvisomant

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy, normal blood tests

You may not qualify if:

  • Previous cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology J 106, Herlev Hospital

Herlev, Herlev, 2730, Denmark

Location

Related Publications (1)

  • Andreassen M, Frystyk J, Faber J, Kristensen LO, Juul A. Growth hormone (GH) activity is associated with increased serum oestradiol and reduced anti-Mullerian hormone in healthy male volunteers treated with GH and a GH antagonist. Andrology. 2013 Jul;1(4):595-601. doi: 10.1111/j.2047-2927.2013.00096.x.

    PMID: 23785020DERIVED

MeSH Terms

Interventions

Human Growth Hormonepegvisomant

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 1, 2009

Study Start

September 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

September 1, 2009

Record last verified: 2009-08

Locations

DK(1)