Clinical trials: Hormone Replacement
Hunter Syndrome, Mucopolysaccharidosis II (MPS II)
Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase
Study TKT024EXT was a long-term, single-arm, open-label extension of Study TKT024, a one year Phase 2/Phase 3 registration study.
- Trial name
- NCT00630747
- Testing
- Idursulfase
- Where
- 52 sites in United States, Brazil and 8 more
- Volunteers
- 94 people
- Sponsor
- Shire
Alcohol Drinking
Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
This study examines the effect of combined nicotine replacement therapy (transdermal patch + nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and self-administration behavior.
- Trial name
- NCT00699556
- Testing
- 21mg transdermal nicotine patch (Nicoderm CQ), 1mg nicotine nasal spray
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Yale University
Lysosomal Acid Lipase Deficiency
Safety and Efficacy Study of Sebelipase Alfa in Participants With Lysosomal Acid Lipase Deficiency
This study evaluated the safety and efficacy of sebelipase alfa in a broad population of participants with lysosomal acid lipase deficiency (LAL-D).
- Trial name
- NCT02112994
- Testing
- Sebelipase Alfa
- Where
- 19 sites in United States, Australia and 13 more
- Volunteers
- 31 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Congenital Adrenal Hyperplasia
Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia
This study is a parallel arm, randomised, open-label study, including dose titration and admissions for four overnight stays for 24-hour endocrine profiles.
- Trial name
- NCT02716818
- Testing
- Chronocort®, standard glucocorticoid therapy
- Where
- United States
- Volunteers
- 122 people
- Sponsor
- Neurocrine UK Limited
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
Nicotine Dependence
An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence
The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe, but most smokers are unable to successfully quit with this form of treatment.
- Trial name
- NCT01047527
- Testing
- Transdermal nicotine patch
- Where
- 2 sites in United States
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Congenital Bleeding Disorder, Congenital FXIII Deficiency
Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725
This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the safety of monthly replacement therapy of recombinant factor XIII in patients with congenital FXIII deficiency.
- Trial name
- mentor™2 (NCT00978380)
- Testing
- catridecacog
- Where
- 34 sites in United States, Austria and 10 more
- Volunteers
- 63 people
- Sponsor
- Novo Nordisk A/S
Hypogonadism, Hypogonadism, Male
A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
Testosterone is the principal androgen produced by the male testes. Male Hypogonadism is the result of inadequate production of testosterone by the Leydig cells of the testes and is reflected by total serum concentrations of…
- Conditions
- Hypogonadism, Hypogonadism, Male, Hypogonadotropic Hypogonadism
- Trial name
- NCT04456296
- Testing
- Aveed Injectable Product, Fortesta, Testim
- Where
- 35 sites in United States
- Volunteers
- 673 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Smoking, Smoking Cessation
A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers
A sample of smokers who have no current plans to quit will be recruited for this study and randomized to one of two intervention conditions: 1. Practice Quit Attempt (PQA) aided by brief advice and self-help materials, or 2.
- Trial name
- NCT00706979
- Testing
- Practice Quit Attempt plus nicotine lozenge, Practice Quit Attempt only
- Volunteers
- 849 people
- Sponsor
- Medical University of South Carolina
Hypogonadism, Diabetes
Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial.
Background: Men≥65 years often produce lower levels of testosterone, meaning there is less testosterone circulating to the tissues of the body.
- Conditions
- Hypogonadism, Diabetes, Sarcopenia, Osteoporosis
- Trial name
- NCT00104572
- Testing
- Androgel (Testosterone Gel), Anastrozole (Aromatase Inhibitor), Calcium Cardone 500mg with vitamin D 400 IU
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- National Institute on Aging (NIA)
Growth Hormone Deficiency
Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency
The study will investigate the effect on growth hormone replacement in patients with isolated growth hormone deficiency on body composition, especially visceral fat mass.
- Trial name
- IGHD (NCT00630487)
- Testing
- Somatropin
- Where
- 2 sites in Germany
- Volunteers
- 9 people
- Sponsor
- Pfizer
Smoking
Stop Smoking Therapy for Ontario Patients
Approximately 2 million Ontarians are current smokers. While smoking rates have declined over the past 25 years, these rates have remained constant since 2002.
- Trial name
- STOP (NCT00352781)
- Testing
- nicotine replacement therapy, behavioural intervention
- Where
- Canada
- Volunteers
- 1,767 people
- Sponsor
- Centre for Addiction and Mental Health
Sarcopenia, Hypogonadism
TOM: Testosterone in Older Men With Sarcopenia
The purpose of this study is to determine whether testosterone replacement in older men with low testosterone levels will increase muscle strength, improve physical performance and overall sense of well being, and reduce fatigue.
- Conditions
- Sarcopenia, Hypogonadism, Muscular Diseases
- Trial name
- NCT00240981
- Testing
- Topical testosterone gel 1% (active formulation)
- Where
- 2 sites in United States
- Volunteers
- 209 people
- Sponsor
- Boston Medical Center
Hunter Syndrome
Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment
Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter…
- Trial name
- AIM-IT (NCT02055118)
- Testing
- idursulfase-IT, No IT treatment
- Where
- 9 sites in United States, Australia and 5 more
- Volunteers
- 58 people
- Sponsor
- Shire
Mucopolysaccharidosis Type 7
An Open-Label Phase 1/2 Study to Assess the Safety, Efficacy and Dose of Study Drug UX003 Recombinant Human Beta-glucuronidase (rhGUS) Enzyme Replacement Therapy in Patients With Mucopolysaccharidosis Type 7 (MPS 7)
UX003-CL201 is an open-label Phase 1/2 study to assess the safety, efficacy, and dose of UX003 in MPS 7 patients via intravenous (IV) administration every other week (QOW) for 36 weeks with up to an additional 36 weeks from the…
- Trial name
- NCT01856218
- Testing
- UX003
- Where
- United Kingdom
- Volunteers
- 3 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Breast Cancer
Protocol for Women at Increased Risk of Developing Breast Cancer
A pilot study to assess the effects of six months of letrozole on breast tissue risk markers in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer.
- Trial name
- NCT00291135
- Testing
- letrozole
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Carol Fabian, MD
Kidney Failure, Acute, Renal Replacement Therapy
Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery
The purpose of this study is to determine if the incidence of acute renal failure (ARF) in high risk patients who undergo coronary artery bypass grafting (CABG) is reduced by treating patients in the perioperative period with…
- Trial name
- NCT00484354
- Testing
- Sodium bicarbonate, Normal saline, Bicarbonate
- Where
- United States
- Volunteers
- 123 people
- Sponsor
- Wake Forest University Health Sciences
MPS 7, Sly Syndrome
A Phase 3 Study of UX003 Recombinant Human Betaglucuronidase (rhGUS) Enzyme Replacement Therapy in Patients With Mucopolysaccharidosis Type 7 (MPS 7)
The Phase 3 study will use a novel randomized, intra-subject placebo-controlled, single crossover design, referred to as Blind Start, to evaluate the safety and efficacy of UX003.
- Conditions
- MPS 7, Sly Syndrome, Mucopolysaccharidosis, MPS VII
- Trial name
- NCT02230566
- Testing
- UX003
- Where
- 4 sites in United States
- Volunteers
- 12 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Nicotine Dependence
Enhancing a High School Based Smoking Cessation Program
The purpose of this study is to examine the the efficacy of adjunctive nicotine replacement therapy when used in combination with the contingency management (CM) + cognitive behavioral therapy intervention.
- Trial name
- NCT01145001
- Testing
- Cognitive Behavioural Therapy, Contingency Management, Nicotine Transdermal Patch
- Where
- United States
- Volunteers
- 154 people
- Sponsor
- Yale University
Smoking Cessation
Effect of Pre-op NRT on Peri-operative Complications and Long-term Abstinence: A Pilot Trial in Patients Undergoing CABG Surgery
This study will determine whether or not patients who use a Nicotine Replacement Therapy (NRT) patch prior to their by-pass surgery are more likely to be smoke-free 6 months after their surgery and have fewer post-operative…
- Trial name
- NCT02918500
- Testing
- Nicoderm Patch
- Where
- Canada
- Volunteers
- 4 people
- Sponsor
- Ottawa Heart Institute Research Corporation