Clinical trials: Pituitary Disorders
Healthy
Pergoveris FD and Liquid China BE Study
The main purpose of this study is to assess the bioequivalence (BE) of the fixed combination of follitropin alfa and lutropin alfa in Pergoveris freeze-dried (FD) (Test 1) or in Pergoveris Liquid (Test 2) versus the…
- Trial name
- NCT04899193
- Testing
- Pergoveris FD, Pergoveris Liquid, Gonal-f
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Growth Hormone Disorder, Adult Growth Hormone Deficiency
Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency
This trial is conducted in Europe. Growth Hormone in young adults with growth hormone deficiency in childhood. This trial compares a treated group of patients with an untreated group of patients.
- Trial name
- NCT00184678
- Testing
- somatropin
- Where
- 30 sites in Australia, Austria and 10 more
- Volunteers
- 161 people
- Sponsor
- Novo Nordisk A/S
Adult Growth Hormone Deficiency (AGHD)
A Study of GS3-007a for Oral Suspension in the Diagnosis of Adult Growth Hormone Deficiency (AGHD)
The GS3-007a Growth Hormone Stimulation Test (GHST) will be compared with the Insulin Tolerance Test (ITT) in an open-label, randomized, three-way crossover trial.
- Trial name
- NCT07259564
- Testing
- GS3-007a dry suspension, Insulin
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Acromegaly
Assessment of BIM23B065, Given as Repeated Subcutaneous Injection in Subjects With Acromegaly
The purpose of the protocol is evaluate the safety, the pharmacodynamics and the pharmacokinetic of repeated administration of BIM23B065 in subjects with acromegaly.
- Trial name
- DOPAACRO 002 (NCT03045302)
- Testing
- BIM23B065
- Where
- 6 sites in Belgium, Hungary and 2 more
- Volunteers
- 4 people
- Sponsor
- Ipsen
Growth Hormone Deficiency
Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)
This is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects…
- Trial name
- OraGrowtH210 (NCT04614337)
- Testing
- LUM-201, rhGH Norditropin® pen (34 µg/kg)
- Where
- 43 sites in United States, Australia and 4 more
- Volunteers
- 104 people
- Sponsor
- Lumos Pharma
Acromegaly
Effect of 120mg Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly
A multicentre, prospective, open label study of acromegalic patients evaluating the efficacy and safety of different dose-intervals of Lanreotide Autogel 120mg according to international standards and compared to previous…
- Trial name
- NCT00444873
- Testing
- lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval
- Where
- Germany
- Volunteers
- 38 people
- Sponsor
- Ipsen
Infertility, Ovulation Induction
SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women
Efficacy and safety studies in the past have suggested that a starting dose of 75 International Unit (IU) of SJ-0021, and an increase in the dose by 37.5 IU every 7 days, are safe for treatment of subjects with ovulatory…
- Trial name
- NCT01185782
- Testing
- Gonalef® (Follitropin alfa), Purified pituitary gonadotropin (Fertinorm-P®)
- Where
- Japan
- Volunteers
- 300 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Adult Growth Hormone Deficiency
A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHD
This study aims to explore the optimal dose of PEG-rhGH injection in the treatment of AGHD, preliminarily evaluate its safety and efficacy, to provide scientific and reliable evidence for the medication dosage in Phase 2 clinical…
- Trial name
- NCT03104010
- Testing
- Somatropin Injection
- Where
- 9 sites in China
- Volunteers
- 180 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Acromegaly
Predictive Factors Study
This is a long term study to evaluate common therapeutic algorithms and possible predictive parameters for Somatuline Autogel treatment in patients with Acromegaly.
- Trial name
- TAPAS (NCT02020499)
- Testing
- Somatuline Autogel® (lanreotide) 60, 90, 120 mg.
- Where
- 6 sites in Australia
- Volunteers
- 5 people
- Sponsor
- Ipsen
Euvolemic Hyponatremia
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic Hyponatremia
The purpose of this study is to evaluate the safety and tolerability of oral lixivaptan capsules in subjects with Euvolemic Hyponatremia.
- Trial name
- NCT00876798
- Testing
- Lixivaptan
- Where
- 90 sites in United States, Belgium and 6 more
- Volunteers
- 206 people
- Sponsor
- CardioKine Inc.
Cushing's Syndrome
An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome
Participants in study C-1073-400 (NCT00569582) will be invited to participate in this extension study to examine the long term safety of mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome.
- Trial name
- NCT00936741
- Testing
- mifepristone
- Where
- 15 sites in United States
- Volunteers
- 30 people
- Sponsor
- Corcept Therapeutics
Growth Hormone Deficiency
Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers
The study is a Phase 1, randomized, double-blind, vehicle-controlled, single-dose, three dose levels study in healthy Caucasian and Japanese male volunteers.
- Trial name
- NCT02418767
- Testing
- MOD-4023
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- OPKO Health, Inc.
Growth Hormone Deficiency
A Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin
The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.
- Trial name
- SkyPASS (NCT05775523)
- Testing
- No intervention
- Where
- 27 sites in United States
- Volunteers
- 500 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Growth Hormone Deficiency
Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children
This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation).
- Trial name
- NCT01495468
- Testing
- PEG-somatropin
- Where
- 6 sites in China
- Volunteers
- 343 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Adult Growth Hormone Deficiency (AGHD)
Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in Adult Growth Hormone Deficiency (AGHD)
Open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with Growth Hormone Deficiency (GHD).
- Trial name
- NCT02719990
- Testing
- somavaratan
- Volunteers
- 36 people
- Sponsor
- Versartis Inc.
Growth Hormone Deficiency
Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency
The purpose of this study is to evaluate the efficacy and safety of recombinant human growth hormone on adult growth hormone deficiency
- Trial name
- NCT02693522
- Testing
- somatropin, Eutropin
- Where
- South Korea
- Volunteers
- 52 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Acromegaly
Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
The purpose of this study is to describe most characteristic association of signs and symptoms present at the time of acromegaly diagnosis.
- Trial name
- ACRO-POLIS (NCT02012127)
- Where
- 25 sites in France
- Volunteers
- 648 people
- Sponsor
- Ipsen
Acromegaly
Study in Polish Acromegalic Patients Treated With Somatuline Autogel
The purpose of this study is to evaluate over the 24 month prospective follow up - in everyday clinical practice - resource utilization and effectiveness of the treatment of acromegalic patients in Poland with Somatuline Autogel…
- Trial name
- NCT01333384
- Where
- Poland
- Volunteers
- 150 people
- Sponsor
- Ipsen
Brain and Central Nervous System Tumors, Breast Cancer
Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer
RATIONALE: Radiolabeled drugs such as yttrium Y 90 SMT 487 can locate tumor cells and deliver tumor-killing substances to them without harming normal cells.
- Conditions
- Brain and Central Nervous System Tumors, Breast Cancer, Gastrointestinal Carcinoid Tumor, Islet Cell Tumor
- Trial name
- NCT00006368
- Testing
- yttrium Y 90-edotreotide
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Growth Hormone Deficiency
Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency
To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of population of children.
- Trial name
- NCT02908958
- Testing
- PEG-somatropin
- Where
- 22 sites in China
- Volunteers
- 900 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.