CLINICAL TRIALS PROFILE FOR GENOTROPIN

All Clinical Trials for Genotropin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00119769 ↗	The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients	Completed	Pfizer	Phase 4	2005-02-01	The purpose of this study is to investigate the effect of low-dose human growth hormone therapy on immune status and fat morphology.
NCT00119769 ↗	The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients	Completed	Hvidovre University Hospital	Phase 4	2005-02-01	The purpose of this study is to investigate the effect of low-dose human growth hormone therapy on immune status and fat morphology.
NCT00136032 ↗	Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient Women	Completed	Massachusetts General Hospital	N/A	2002-01-01	The purpose of the study is to evaluate the effects of growth hormone replacement on women with growth hormone deficiency. Growth hormone deficiency means the body no longer produces growth hormone due to a tumor or some kind of disease of the brain in an area called the pituitary/hypothalamic region. This is the area of the brain where growth hormone is normally produced. We, the researchers at Massachusetts General Hospital, will establish the effects of growth hormone replacement on cardiovascular parameters (laboratory tests, the flexibility of the arteries, changes in heart rate) in women with growth hormone deficiency. Our goal is to see if this therapy: - has effects on women's cardiovascular risk markers (special blood tests which indicate how healthy the heart and arteries are) - has effects on women's types and levels of various substances circulating in their blood - in women affects the stiffness of their arteries and heart rate variability in parallel with changes in cardiovascular risk markers - has different effects depending on whether women are pre or post menopausal. Participation in this study is expected to last approximately 12 months.
NCT00174408 ↗	Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age	Completed	Pfizer	Phase 3	1990-03-01	The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in short children born SGA. Safety of the drug is a main objective as well. The growth promoting effect of two different dosages is compared. The effect of long-term treatment on final height is evaluated (according to several amendments)
NCT00174421 ↗	Treatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height	Completed	Pfizer	Phase 3	2001-04-01	This trial evaluates whether long-term treatment with Genotropin normalizes final (adult) height in short children born small for gestational age
NCT00209235 ↗	Albright Hereditary Osteodystrophy: Growth Hormone Trial and Cognitive/Behavioral Assessments	Recruiting	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2/Phase 3	2003-01-01	We, the researchers, have found that growth hormone deficiency is very common in patients with pseudohypoparathyroidism type 1a, which falls under the broader condition termed Albright hereditary osteodystrophy. Patients with pseudohypoparathyroidism type 1a typically are short and obese. Some of these patients are not short during childhood, but due to a combination of factors, they end up short as adults. We are evaluating the effect of growth hormone treatment in those patients with pseudohypoparathyroidism type 1a who are found to be growth hormone deficient. We hypothesize that growth hormone deficiency may contribute to the short stature and obesity found in this condition. We are also evaluating the effect of growth hormone on patients with pseudohypoparathyroidism type 1a who are not growth hormone deficient (i.e., growth hormone sufficient) in those who had been on study drug through R01 FD003409 or who meet the criteria of idiopathic short stature or SGA. We are also evaluating neurocognitive and psychosocial functioning in participants with AHO in order to determine the specific impairments that are most common in the condition and to determine the best approach toward management. Funding source -- Growth hormone study: FDA OOPD [R01 FD003409 (which has ended) and R01 FD002568 (which has ended)] Cognitive/behavior: NICHD R21 HD078864

Clinical Trial Conditions for Genotropin

Condition Name

Condition Name for Genotropin
Intervention	Trials
Growth Hormone Deficiency	9
Traumatic Brain Injury	4
Growth Disorder	3
Healthy	3

Condition MeSH

Condition MeSH for Genotropin
Intervention	Trials
Dwarfism, Pituitary	16
Endocrine System Diseases	11
Dwarfism	6
Brain Injuries, Traumatic	6

Clinical Trial Locations for Genotropin

Trials by Country

Trials by Country for Genotropin
Location	Trials
United States	66
Japan	30
Spain	8
India	6
Korea, Republic of	6

Trials by US State

Trials by US State for Genotropin
Location	Trials
Texas	7
New York	5
Florida	4
Colorado	4
California	4

Clinical Trial Progress for Genotropin

Clinical Trial Phase

Clinical Trial Phase for Genotropin
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	17
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for Genotropin
Clinical Trial Phase	Trials
Completed	37
Terminated	4
Active, not recruiting	3

Clinical Trial Sponsors for Genotropin

Sponsor Name

Sponsor Name for Genotropin
Sponsor	Trials
Pfizer	21
The University of Texas Medical Branch, Galveston	4
University of Aarhus	3

Sponsor Type

Sponsor Type for Genotropin
Sponsor	Trials
Industry	38
Other	32
U.S. Fed	1