Who is sponsoring NCT00080483?

NCT00080483 is sponsored by University of Pennsylvania.

What drugs are being tested in NCT00080483?

Interventions in NCT00080483: Testosterone plus somatropin, testosterone.

What condition does NCT00080483 study?

NCT00080483 studies Hypopituitarism, Hypogonadism, Growth Hormone Deficiency.

Is NCT00080483 still recruiting?

NCT00080483 is currently completed. Last updated 12 June 2014.

Are results published for NCT00080483?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2014-06-12 · How we verify

NCT00080483

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Will Testosterone and Growth Hormone Improve Bone Structure?

Completed Phase 2 Results posted Last updated 12 June 2014

What this trial tests

Phase 2 trial testing Testosterone plus somatropin in Hypopituitarism in 35 participants. Completed in 1 September 2010.

Timeline

1 March 2004

Primary endpoint
1 September 2010

1 September 2010

Quick facts

Lead sponsor	University of Pennsylvania
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	1 March 2004
Primary completion	1 September 2010
Estimated completion	1 September 2010
Sites	1 location across United States

Drugs / interventions tested

Testosterone plus somatropin — full drug profile →
testosterone (TESTOSTERONE) — full drug profile →

Conditions studied

Hypopituitarism — all drugs for Hypopituitarism →
Hypogonadism — all drugs for Hypogonadism →
Growth Hormone Deficiency — all drugs for Growth Hormone Deficiency →

Sponsor

University of Pennsylvania

Who can join

18 and older, male only, with Hypopituitarism or Hypogonadism. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment.
Time frame: baseline, one year, two years
Increased bone volume fraction (the fraction of bone that is bone, as opposed to the fraction that is marrow), as determined by magnetic resonance of the distal tibia

Sponsor's own description

Deficiency of testosterone, growth hormone, or both hormones can result in osteoporosis. If either hormone is replaced, the condition of the bones improves. The purpose of this study is to determine if dual hormone treatment for men deficient in testosterone and growth hormone improves bone structure more than testosterone treatment alone.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other University of Pennsylvania trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00080483 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Pennsylvania
Last refreshed: 12 June 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00080483.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing