🧪 TrialInsufficient
Registered Phase 1 interventional trial (completed). The objective of this study is to evaluate the safety, tolerance, pharmacokinetics and the potential immunological reaction of single intravenous recombinant human thymosin β4（NL005）or placebo 0.05, 0.25, 0.5, 2, 5, 12.5, 25μg/kg in Chinese healthy volunteers. 54 volunteers will be randomized to receive NL005 or placebo for 7 cohorts,administered iv by iv push on Day 1.
ClinicalTrials.gov · Sep 2020View trial ↗ 🧪 TrialInsufficient
Registered Phase 1 interventional trial (completed). The objective of this study is to evaluate the safety, tolerance, pharmacokinetics and the potential immunological reaction of single intravenous recombinant human thymosin β4（NL005）or placebo 0.5, 2.0,5.0μg/kg in Chinese healthy volunteers.30 volunteers will be randomly assigned to one of three groups to receive either NL005 or placebo for 10 consecutive days.
ClinicalTrials.gov · Sep 2020View trial ↗ 🧪 TrialInsufficient
Registered Phase 3 interventional trial (completed). The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.
ClinicalTrials.gov · May 2019View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (completed), with sponsor-posted results. Nonalcoholic fatty liver disease (NAFLD) is common in individuals with obesity and is a significant threat to public health, because it can lead to impaired liver function and liver failure. Growth hormone is a hormone produced in the pituitary gland that helps regulate metabolism and growth. Individuals with obesity, on average, secrete less growth hormone than individuals without obesity. There are data to suggest that growth hormone may help to reduce the amount of fat in the liver, and may also reduce inflamm
ClinicalTrials.gov · Dec 2017View trial ↗ 🧪 TrialInsufficient
Registered observational trial (active not recruiting). Empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was launched as a treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with several previous cardiovascular outcomes trials, which failed to demonstrate an association with a higher or a lower risk of cardiovascular outcomes associated with members of other recently marketed antidiabetic classes, the EMPA-REG OUTCOME trial has shown that patients at high cardiovascular risk randomized to empagliflozin vs. placebo, were associated with a r
ClinicalTrials.gov · Dec 2017View trial ↗ 🧪 TrialInsufficient
Registered Phase 1 interventional trial (completed). The purpose of the study is to investigate the drug octreotide acetate in a new intranasal formulation and compare it to the FDA-approved subcutaneous (SC) injection formulation. The two octreotide acetate formulations will be evaluated following separate administrations for safety and tolerability including any side effects, the speed at which the drug is absorbed and eliminated in the body, and the ability of the drug to lower the levels of growth hormone (GH) and insulin-like growth factor 1 (IGF-1).
ClinicalTrials.gov · Jan 2017View trial ↗ 🧪 TrialInsufficient
Registered N/A interventional trial (completed). The purpose of this study was to validate the growth hormone releasing hormone (GHRH) plus arginine (GHRH+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth hormone deficiency using the growth hormone (GH) Immulite 2000 Xpi assay calibrated against the IS 98/574 from the World Health Organization. A specific aim was to study the effect of gender and age on the peak GH response in the GHRH+arg test
ClinicalTrials.gov · Jan 2017View trial ↗ 🧪 TrialLimited · human
Registered Phase 3 interventional trial (completed), with sponsor-posted results. The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
ClinicalTrials.gov · Nov 2016View trial ↗ 🧪 TrialInsufficient
Registered Phase 3 interventional trial (unknown). 300 women with expected poor ovarian response (POR) undergoing in vitro fertilization or intra-cytoplasmic sperm injection (ICSI) will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Dehydroepiandrosterone (DHEA) 25 mg ( DHEA 25mg, Natrol , USA) t.d.s daily for 12 weeks before starting IVF/ICSI cycle and a placebo similar to growth hormone (GH) daily from day 6 of stimulation until the day of human chorionic gonadotrophin (hCG) trigger. Group 2 will receive an oral placebo t.d.s. daily for
ClinicalTrials.gov · Apr 2016View trial ↗ 🧪 TrialInsufficient
Registered Phase 1 interventional trial (unknown). Phase I clinical trial in healthy volunteers to study safety and pharmacokinetics of BPC-157, a pentadecapeptide from gastric source.
ClinicalTrials.gov · Dec 2015View trial ↗ 🧪 TrialInsufficient
Registered Phase 2/Phase 3 interventional trial (completed). The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
ClinicalTrials.gov · Nov 2015View trial ↗ 🧪 TrialInsufficient
Registered Phase 1 interventional trial (completed). This study is examining the effects of growth hormone releasing hormone (GHRH) on mild cognitive impairment (MCI). GHRH will be given at a dose of 1mg/day for 10 weeks to subjects with MCI as well as healthy controls.
ClinicalTrials.gov · Sep 2015View trial ↗ 🧪 TrialLimited · human
Registered Phase 3 interventional trial (completed), with sponsor-posted results. A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.
ClinicalTrials.gov · Jan 2015View trial ↗ 🧪 TrialLimited · human
Registered Phase 3 interventional trial (completed), with sponsor-posted results. A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.
ClinicalTrials.gov · Jan 2015View trial ↗ 🧪 TrialInsufficient
Registered Phase 1 interventional trial (completed). Repletion of testosterone (Te) in older men drives GH secretion after its aromatization to estradiol (E2), which acts via the estrogen receptor (ER). Conversely, we postulate that estrogen deprivation in postmenopausal women attenuates growth hormone (GH) secretion and insulin-like growth factor-1 (IGF-I) production, thus favoring development of metabolic syndrome in men treated with toremifene, a new estrogen antagonist used adjunctively in prostatic cancer
ClinicalTrials.gov · Oct 2014View trial ↗ 🧪 TrialLimited · human
Registered N/A interventional trial (completed), with sponsor-posted results. Liver disease is one of the leading co-morbidities of human immunodeficiency virus (HIV) infection, and nonalcoholic fatty liver disease (NAFLD) is present in approximately 30-40% of patients with HIV infection. Nonalcoholic steatohepatitis (NASH) is a more severe form of NAFLD in which increased liver fat is also accompanied by inflammation, cellular damage, and fibrosis. NAFLD is most prevalent in patients who also have increased visceral adiposity, and our group has previously shown that HIV-infected individuals w
ClinicalTrials.gov · Jul 2014View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (terminated), with sponsor-posted results. The purpose of the study is to evaluate the effect of a naturally occurring hormone, called Growth Hormone Releasing Hormone (GHRH) on the muscle, bone, and fat tissues of the body. GHRH stimulates the production of growth hormone (GH), which regulates the build up of many tissues in the body, including muscles and bones. Many elderly people have low levels of GH. The overall goal of this research is to determine the efficacy of GHRH to raise levels of GH and improve these body tissues. Healthy men and women age
ClinicalTrials.gov · Aug 2011View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (completed), with sponsor-posted results. Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort. Tear substitutes are an important part of the treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often remains very irregular due to poor surface healing. The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal surface and has been studied in patients with recalcitrant corneal ulcers and erosions with significant
ClinicalTrials.gov · Jul 2011View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (completed), with sponsor-posted results. Thymosin Beta 4 (Tβ4) is a synthetic copy of the naturally-occurring 43-amino acid peptide that is found in a variety of tissues. Tβ4 promotes/accelerates wound repair in dermal, ocular, and cardiac animal models. Two recent pre-clinical evaluations have demonstrated that Tβ4 promotes corneal ocular surface defects healing in animal models of dry eye. RGN-259 (formulation of Tβ4 ophthalmic solution) mechanism of action offers potential to be a product that meets a major unmet medical need in patients with dry eye
ClinicalTrials.gov · Jul 2011View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (completed), with sponsor-posted results. This trial is designed to evaluate the efficacy and safety of 3 fixed dose levels of bremelanotide, administered subcutaneously on an as-needed basis under conditions of home use, for the treatment of female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or mixed FSAD/HSDD in premenopausal women.
ClinicalTrials.gov · Jun 2011View trial ↗