Clinical trials: Hormone Replacement Therapy
Klinefelter Syndrome, XXY Syndrome
Study of Psychological and Motor Effects of Testosterone in Adolescents With XXY/Klinefelter Syndrome
The purpose of this study is to determine if testosterone replacement therapy leads to changes in psychological factors and/or motor skills in adolescent males with 47,XXY (also called Klinefelter syndrome).
- Trial name
- TestoXXY/KS (NCT01585831)
- Testing
- Testosterone gel 1%
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of Colorado, Denver
Mucopolysaccharidosis I
Immune Tolerance Study With Aldurazyme® (Laronidase)
The purpose of this study is to see if treatment with an antigen-specific immunosuppressive can decrease or stop an antibody response to laronidase (Aldurazyme®) during enzyme replacement therapy with laronidase in severe…
- Trial name
- NCT00741338
- Testing
- Laronidase, Cyclosporine A (CsA), Azathioprine (Aza)
- Where
- 2 sites in Brazil, Russia
- Volunteers
- 7 people
- Sponsor
- Genzyme, a Sanofi Company
Acute Kidney Injury, End-stage Renal Disease
Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy
Purpose of this study is to evaluate the short-term hemodynamic effects of changes in blood flow rates in critically ill patients receiving continuous renal replacement therapy.
- Trial name
- NCT03078504
- Testing
- continuous renal replacement therapy using System One (TM) setup (Nxstage)
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- St. Louis University
Smoking Cessation
Providing Free Nicotine Patches to Quitline Smokers
The California Smokers' Helpline will conduct a 3 X 2 (nicotine patch by counseling condition) randomized trial to test the provision of nicotine patches to help smokers calling a telephone quitline.
- Trial name
- NCT01736085
- Testing
- Telephone counseling, Voucher, Nicotine patches
- Where
- United States
- Volunteers
- 3,706 people
- Sponsor
- University of California, San Diego
Mucopolysaccharidosis IV A, Morquio A Syndrome
Long-Term Efficacy and Safety Extension Study of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)
This Phase 3 extension study will evaluate the long-term efficacy and safety of BMN 110 2.0 mg/kg/week and/or BMN 110 2.0 mg/kg/every other week in patients with mucopolysaccharidosis IVA (Morquio A Syndrome).
- Conditions
- Mucopolysaccharidosis IV A, Morquio A Syndrome, MPS IVA
- Trial name
- NCT01415427
- Testing
- BMN 110 - Weekly, BMN 110 - Every Other Week
- Where
- 43 sites in United States, Argentina and 18 more
- Volunteers
- 173 people
- Sponsor
- BioMarin Pharmaceutical
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.
Nicotine Dependence
Assessment of High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine
Unfortunately, the investigators still need to assess and identify novel ways to help people quit smoking. Differences between people in terms of how fast they metabolize nicotine influences response to transdermal nicotine…
- Trial name
- HDP (NCT00956943)
- Testing
- Nicoderm CQ transdermal nicotine
- Where
- United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Chronic Renal Anemia
A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)
This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not…
- Trial name
- NCT00773513
- Testing
- Darbepoetin Alfa, Epoetin Alfa, Epoetin Beta
- Where
- 196 sites in Argentina, Australia and 25 more
- Volunteers
- 2,825 people
- Sponsor
- Hoffmann-La Roche
Smoking Cessation
Telephone Counseling and the Distribution of Nicotine Patches to Smokers
The primary purpose of this study is to determine the effects of distributing free nicotine replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims to: 1.
- Trial name
- NCT00851357
- Testing
- Nicotine Patch, Telephone Counseling, Self-Help Materials
- Where
- United States
- Volunteers
- 4,200 people
- Sponsor
- University of California, San Diego
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
Lysosomal Acid Lipase Deficiency
Acid Lipase Replacement Investigating Safety and Efficacy (ARISE) in Participants With Lysosomal Acid Lipase Deficiency
This Phase 3 study evaluated the efficacy and safety of 1 milligram/kilogram (mg/kg) intravenous (IV) infusions of SBC-102 (sebelipase alfa) administered every other week (qow) in participants with late onset lysosomal acid…
- Trial name
- ARISE (NCT01757184)
- Testing
- Sebelipase Alfa
- Where
- 40 sites in United States, Argentina and 13 more
- Volunteers
- 66 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Smoking
Cessation in Non-Daily Smokers
The purpose of this study is to examine the effect of as-needed oral Nicotine Replacement Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in non-daily, or intermittent, smokers, and to study the process of relapse in…
- Trial name
- QUITS (NCT02168855)
- Testing
- active nicotine gum, Standard behavioral therapy
- Where
- United States
- Volunteers
- 505 people
- Sponsor
- Brian Primack
Menopause
Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).
The study has been designed to look at the transfer from using LNG IUS for contraception only, in reproductive age to using it for endometrial protection in menopausal age.
- Trial name
- NCT00185458
- Testing
- LNG IUS
- Where
- 12 sites in Belgium, Finland and 2 more
- Volunteers
- 394 people
- Sponsor
- Bayer
Fabry Disease
A Study of Fabrazyme in Pediatric Patients With Fabry Disease
People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the a-galactosidase A enzyme.
- Trial name
- NCT00074958
- Testing
- Fabrazyme (agalsidase beta)
- Where
- 7 sites in United States, France and 2 more
- Volunteers
- 16 people
- Sponsor
- Genzyme, a Sanofi Company
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
Congenital Bleeding Disorder, Congenital FXIII Deficiency
Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency
The trial is conducted in Europe, North America and Asia. The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency.
- Trial name
- NCT00713648
- Testing
- catridecacog
- Where
- 35 sites in United States, Austria and 9 more
- Volunteers
- 41 people
- Sponsor
- Novo Nordisk A/S
Gaucher Disease, Type 1
A Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Gaucher Disease
Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme glucocerebrosidase (GCB). Due to this deficiency of functional GCB, glucocerebroside accumulates within macrophages leading to cellular…
- Trial name
- NCT00430625
- Testing
- VPRIV ®,
- Where
- 5 sites in Argentina, Israel and 3 more
- Volunteers
- 25 people
- Sponsor
- Shire
Fabry Disease
A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease
People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the alpha-galactosidase A enzyme.
- Trial name
- NCT00196716
- Testing
- Fabrazyme (agalsidase beta)
- Where
- 4 sites in Czechia, Estonia and 2 more
- Volunteers
- 21 people
- Sponsor
- Genzyme, a Sanofi Company
Hypogonadism, Erectile Dysfunction
Testosterone for Penile Rehabilitation After Radical Prostatectomy
The purpose of this study is to determine the effectiveness of testosterone replacement therapy (TRT) in men following surgery to remove the prostate in improving erectile function.
- Trial name
- NCT00848497
- Testing
- Testim®, Viagra®
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Mohit Khera
Physical Frailty, Hip Fracture
Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
The primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether exercise training combined with testosterone replacement therapy can improve skeletal muscle strength, and lean mass, to a…
- Conditions
- Physical Frailty, Hip Fracture, Elective Hip Replacement, Hypogonadism
- Trial name
- NCT00345969
- Testing
- Transdermal Testosterone gel (1%), Supervised exercise training
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Washington University School of Medicine