Clinical trials: Hormone Replacement
HIV, Opioid Dependence
Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users
To conduct a randomized clinical trial (RCT) of a community-friendly behavioral intervention designed to reduce HIV risk behavior among injection drug users (IDUs) in drug treatment by comparing risk-behavior outcomes of four…
- Trial name
- NCT01741350
- Testing
- Community-friendly Health Recovery Program, Time-and-Attention-Matched Control Condition
- Where
- United States
- Volunteers
- 304 people
- Sponsor
- University of Connecticut
Hypercalciuria, Hypercalciuria, Familial Idiopathic
The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass
The purpose of this study is to assess if estrogen replacement normalizes urinary calcium excretion in postmenopausal women with hypercalciuria and low bone mass and to assess for differences in response to estrogen replacement…
- Conditions
- Hypercalciuria, Hypercalciuria, Familial Idiopathic, Osteopenia, Osteoporosis
- Trial name
- NCT01928082
- Testing
- Transdermal estradiol
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Chicago
Fabry Disease
Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-naïve Adult Male Patients With Fabry Disease
Primary Objective: To assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and exploratory efficacy of GZ/SAR402671 in enzyme replacement therapy treatment-naïve adult male participants diagnosed with Fabry disease.
- Trial name
- NCT02228460
- Testing
- GZ/SAR402671
- Where
- 8 sites in United States, France and 3 more
- Volunteers
- 11 people
- Sponsor
- Genzyme, a Sanofi Company
Tobacco Use Cessation
Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study
The goal of this research study is to learn about 2 different interactive methods that are designed to help people with HIV/AIDS stop smoking.
- Trial name
- NCT02302859
- Testing
- Nicotine Patch, Questionnaires, Pamphlet
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
Hypogonadism
Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men
The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.
- Trial name
- NCT01104246
- Testing
- Testerone Transdermal System
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Watson Pharmaceuticals
Mucopolysaccharidosis II
Iduronate-2-sulfatase Enzyme Replacement Therapy in Mucopolysaccharidosis II (MPS II)
The purpose of this study is to determine whether the administration of iduronate-2-sulfatase enzyme in a weekly or every other week therapy frequency is safe and efficacious in patients with MPS II.
- Trial name
- NCT00069641
- Testing
- Iduronate-2-sulfatase enzyme replacement therapy
- Where
- 9 sites in United States, Brazil and 2 more
- Volunteers
- 96 people
- Sponsor
- Shire
Acute Kidney Injury
Renal Replacement Therapy and In-Hospital Mortality Incidence in Cardiac Surgery Associated Acute Kidney Injury
The goal of this study is to analyse the relation of severe acute kidney injury post cardiac surgery which characterised by the need of renal replacement therapy, with in-hospital postoperative mortality incidence.
- Trial name
- NCT06091982
- Testing
- Renal Replacement Therapy (RRT)
- Where
- Indonesia
- Volunteers
- 1,113 people
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
Smoking Cessation
Nicotine Lozenge Bioequivalence Study
To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.
- Trial name
- NCT01536704
- Testing
- Nicotine (2 mg), Nicotine (4 mg)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Growth Hormone Deficiency (GHD)
Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
A six month study of ACP-001, a long-acting growth hormone product, versus standard human growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone (hGH) will be given on a daily basis.
- Trial name
- NCT01947907
- Testing
- ACP-001, Human Growth Hormone
- Where
- 36 sites in Belarus, Bulgaria and 12 more
- Volunteers
- 53 people
- Sponsor
- Ascendis Pharma A/S
Mucopolysaccharidosis IVA, Morquio A Syndrome
Study of BMN 110 in Pediatric Patients < 5 Years of Age With Mucopolysaccharidosis IVA (Morquio A Syndrome)
This open-label Phase 2 study will evaluate the safety and efficacy of weekly 2.0 mg/kg/wk infusions of BMN 110 in pediatric patients, less than 5 years of age at the time of administration of the first dose of study drug…
- Conditions
- Mucopolysaccharidosis IVA, Morquio A Syndrome, MPS IVA
- Trial name
- NCT01515956
- Testing
- BMN 110
- Where
- 5 sites in United States, Italy and 2 more
- Volunteers
- 15 people
- Sponsor
- BioMarin Pharmaceutical
Smoking Cessation
Use of Nicotine Replacement Therapy (NRT) Sample and Brief Smoking Cessation Advice for Recruiting Smokers
Background More than 60% of the daily smokers in Hong Kong have never tried and have no intention to quit smoking. About 30.8% of daily smokers attempted to quit but failed.
- Trial name
- NCT03717051
- Testing
- Nicotine replacement therapy (NRT) sampling, Medication counseling
- Where
- Hong Kong
- Volunteers
- 834 people, healthy volunteers welcome
- Sponsor
- The University of Hong Kong
Smoking
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 (THS 2.2)
The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile (rate and amount of nicotine absorbed) following a single use of the THS 2.2 compared to the PK profiles from a single use of a…
- Trial name
- NCT01967732
- Testing
- THS 2.2, CC, NNS
- Where
- United Kingdom
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Spinal Muscular Atrophy Type I
Single-Dose Gene Replacement Therapy Using for Patients With Spinal Muscular Atrophy Type 1 With One or Two SMN2 Copies
This is a Phase 3, open-label, single-arm, single-dose, trial of onasemnogene abeparvovec-xioi (gene replacement therapy) in participants with spinal muscular atrophy (SMA) Type 1 and who are genetically defined by a biallelic…
- Trial name
- NCT03837184
- Testing
- Onasemnogene Abeparvovec-xioi
- Where
- 4 sites in Japan, South Korea and 1 more
- Volunteers
- 2 people
- Sponsor
- Novartis Gene Therapies
Smoking, Smoking Cessation
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
The purpose of this study is to learn if a mindfulness-based smoking cessation smartphone app can help people quit smoking and stay on antiretroviral therapies.
- Conditions
- Smoking, Smoking Cessation, HIV
- Trial name
- NCT03999411
- Testing
- Nicoderm C-Q Transdermal Product, Adherence to Antiretroviral Therapy Counseling, Behavioral Smoking Cessation Counseling
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- University of Miami
Primary Ovarian Insufficiency
Primary Ovarian Insufficiency: Phenotype and Optimal Treatment
This pilot study will observe the progression of newly diagnosed POI patients physical and psychology outcomes after initiating standard of care HRT treatment in comparison to healthy female control participants' physical and…
- Trial name
- NCT03568708
- Testing
- Transdermal Estrogen
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis
Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration…
- Trial name
- SIMPLICITY (NCT02734810)
- Testing
- Liprotamase Powder for Oral Solution
- Where
- 21 sites in United States
- Volunteers
- 15 people
- Sponsor
- Anthera Pharmaceuticals
Sly Syndrome, MPS VII
Study of UX003 Recombinant Human Beta-Glucuronidase (rhGUS) Enzyme Replacement Treatment in Mucopolysaccharidosis Type 7, Sly Syndrome (MPS 7) Patients Less Than 5 Years of Age
The primary objective was to evaluate the effect of UX003 treatment in pediatric MPS VII participants less than 5 years of age on safety, tolerability, and efficacy as determined by the reduction of urinary glycosaminoglycans…
- Conditions
- Sly Syndrome, MPS VII, Mucopolysaccharidosis, Mucopolysaccharidosis VII
- Trial name
- NCT02418455
- Testing
- UX003
- Where
- 5 sites in United States, Portugal and 1 more
- Volunteers
- 8 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Tobacco Use Cessation
Improving Quitline Support Study
This study seeks to evaluate ways to improve outcomes for low-education, uninsured or Medicaid-eligible smokers who do not successfully quit with standard telephone quit line treatment.
- Trial name
- IQS (NCT03538938)
- Testing
- 1-Call Quitline Counseling, 4-Call Quitline Counseling, Nicotine patch
- Where
- United States
- Volunteers
- 1,316 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Primary Immunodeficiency Disease
Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)
- Trial name
- NCT02810444
- Testing
- IgG Next Generation (BT595)
- Where
- 19 sites in United States, Germany and 3 more
- Volunteers
- 81 people
- Sponsor
- Biotest
Acute Kidney Injury in Pediatric Patients
Prismaflex HF20 Set and Prismaflex® System 7.10/7.20 for Acute Continuous Renal Replacement Therapy (CRRT) in Children
The primary objective of this study is to evaluate the efficacy of the Gambro Prismaflex® HF20 Set based on testing the hypothesis that it delivers sufficient renal replacement therapy to effectively treat acute kidney injury…
- Trial name
- NCT02561247
- Testing
- Prismaflex HF20 CRRT Filter, Prismaflex® System 7.10 and 7.20
- Where
- 6 sites in United States
- Volunteers
- 23 people
- Sponsor
- Vantive Health LLC