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Dwarfism, Pituitary clinical trials

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NCT ID: NCT01120977 Completed - Clinical trials for Growth Hormone Deficiency

Reference Values for Body Composition Parameters and IGF-I in the Adult NordiNet® International Outcome Study

Start date: May 2010
Phase: N/A
Study type: Observational

The treatment of Growth Hormone deficiency (GHD) patients with GH, often induce fluid retention; this effect is dose dependent and temporary. The symptoms are swelling of soft tissue and joint stiffness. The objective of this study is to create bioelectric impedance/arm muscle area (BIA/AMA) reference data, as a measurement of hydration status, of healthy persons of both genders in the age 20-70 years.

NCT ID: NCT01112865 Completed - Clinical trials for Growth Hormone Deficiency

Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects

CHOOSE
Start date: August 2010
Phase: Phase 3
Study type: Interventional

Convenience and preference for the new Mark VII pen compared to the current Genotropin pen will be assessed using a questionaire. it is expected that the new pen will be preferred or at least no different to the current pen.

NCT ID: NCT01109017 Completed - Clinical trials for Adult Growth Hormone Deficiency

Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency

Start date: October 2009
Phase: N/A
Study type: Observational

This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® long-term treatment of growth hormone deficiency in adults.

NCT ID: NCT01090778 Completed - Clinical trials for Growth Hormone Deficiency

Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)

Start date: October 2010
Phase: Phase 2
Study type: Interventional

This is an exploratory trial with four cross-over arms measuring the pharmacokinetic and pharmacodynamic profiles of growth hormone using two different modes of growth hormone administration (subcutaneous infusion into the abdomen or subcutaneous bolus injection in the thigh) in 8 adult male or female patients with growth hormone deficiency during interval exercise or in supine rest. The order of dosing regimen within the groups and between the groups will be randomised. All patients will go through four different treatment sessions:A/B Single subcutaneous bolus injection, supine rest without/with interval exercise, sessions C/D: Continuous subcutaneous infusion, supine rest without/with interval exercise. Hypotheses: 1) There is day-to-day variation of exogenous growth hormone, 2)Concentration of growth hormone decreases due to exercise compared to supine rest, 3)There is a circadian variation in pharmacokinetics of exogenous growth hormone infused subcutaneously

NCT ID: NCT01088399 Completed - Hypopituitarism Clinical Trials

A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults

HypoCCS
Start date: September 2002
Phase: N/A
Study type: Observational

The Hypopituitary Control and Complications Study "HypoCCS" is a prospective, open label, global, multicentre, observational study on routine clinical care of adults with growth hormone deficiency occurring either isolated or in combination with other pituitary hormone deficiencies. The objective of this observational study is to evaluate long-term safety and health outcomes for adult growth hormone deficient participants with or without somatropin replacement therapy. As an observational study, data are collected only as provided at the discretion of the attending physician. The participant enrolled meet the criteria of growth hormone deficiency in adults as per the Humatrope label in the country where their attending physician practices, and this diagnosis is at the discretion of the attending physician. The decision to receive somatropin or remain untreated is made by the participant in consultation with their attending physician. While treatment of adult growth hormone deficient participants with somatropin has been shown to be safe and effective in clinical trials of 18 months duration, this observational study aims to provide information on health outcome and replacement therapy over longer periods of time for a larger number of participants in the context of the overall disease environment.

NCT ID: NCT01080755 Completed - Clinical trials for Adult Growth Hormone Deficiency

Metabolic Endocrinology and Growth Hormone in Adults

MEGHA FRANCE
Start date: December 2003
Phase: N/A
Study type: Observational

This is a multicentric, longitudinal, observational study with the prospective follow-up of Adult subjects with Growth Hormone Deficiency (AGHD) being treated with Saizen, every six months in the first year and then annually. At the request of health authorities, the sponsor has arranged for the follow-up of prescriptions and treated subjects within the scope of this indication.

NCT ID: NCT01062529 Completed - Diabetes Clinical Trials

Peripheral Metabolic Effects of Somatostatin

Start date: October 2009
Phase: N/A
Study type: Interventional

The aim of this study is to investigate peripheral effects of Somatostatin on glucose metabolism and growth hormone (GH) signalling in healthy men. Eight subjects will be enrolled. The hypothesis is that Somatostatin infusion reverses insulin resistance caused by GH.

NCT ID: NCT01060488 Completed - Clinical trials for Growth Hormone Deficiency

Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency

Start date: January 2004
Phase: Phase 3
Study type: Interventional

The aim of the study is to determine the specificity and sensitivity of the combined growth hormone releasing hormone (GHRH) + Arginine test in healthy volunteers, subjects with highly probable adult growth hormone deficiency (AGHD) and subjects who were probably free of AGHD.

NCT ID: NCT01034735 Completed - Clinical trials for Growth Hormone Deficiency

r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial

Start date: July 2008
Phase: Phase 1
Study type: Interventional

The primary objective of the trial was to assess the bioequivalence for two concentrations (5.83 mg/mL and 8 mg/mL) of the new r-hGH liquid multidose formulation using the r hGH freeze-dried multidose formulation (Saizen® 8 mg, 8.8 mg/1.51 mL) as reference. Each volunteer received three r hGH treatments, with each treatment being administered as a single subcutaneous dose of 4 mg r-hGH in a randomized sequence with at least one week of wash-out period between successive treatments.

NCT ID: NCT01009905 Completed - Clinical trials for Growth Hormone Disorder

An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone)

ANSWER
Start date: June 24, 2002
Phase: N/A
Study type: Observational

This study is conducted in the United States of America (USA). The aim of this observational study is to collect data concerning the treatment outcomes and safety for children and adults who are prescribed Norditropin®. Specific objectives include: 1) developing models defining the relationship of Norditropin dose to changes in insulin-like growth factor (IGF-I) and treatment outcomes, accounting for independent factors such as age, gender and puberty and 2) determining the relative predictive values of peak growth hormone (GH) and IGF-I levels and other factors before treatment to clinical outcomes.