Clinical trials: Menopausal Hormone Therapy
Anemia
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients
The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients with chronic kidney disease who are not on dialysis.
- Trial name
- NCT00255424
- Testing
- ferumoxytol or oral iron
- Where
- 19 sites in United States
- Volunteers
- 304 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Common Variable Immunodeficiency, X-linked Agammaglobulinemia
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy
The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).
- Conditions
- Common Variable Immunodeficiency, X-linked Agammaglobulinemia, Autosomal Recessive Agammaglobulinemia
- Trial name
- NCT00542997
- Testing
- Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)
- Where
- 19 sites in France, Germany and 7 more
- Volunteers
- 51 people
- Sponsor
- CSL Behring
Coronary Artery Disease, Atherosclerosis
Effect of ACP-501 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Subjects With Coronary Artery Disease
This study is a phase 1, intravenous, open-label, single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-501 (recombinant human Lecithin Cholesterol Acyl Transferase…
- Trial name
- NCT01554800
- Testing
- ACP-501
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- MedImmune LLC
Osteoporosis
A Study to Assess the Safety and Efficacy of 3 Doses of ALX1-11 (50, 75, and 100µg) in the Treatment of Postmenopausal Osteoporosis
A double-blind, placebo-controlled, parallel-group study to assess the safety and efficacy of 3 doses of ALX1-11 (recombinant human parathyroid hormone [rhPTH(1-84)])(50, 75 and 100 µg) in the treatment of postmenopausal…
- Trial name
- NCT00172107
- Testing
- ALX1-11 50 mcg, ALX1-11 75mcg, ALX1-11
- Where
- 19 sites in United States, Canada
- Volunteers
- 217 people
- Sponsor
- Shire
Postmenopause
Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
The purpose of this study is to demonstrate endometrial safety of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone.
- Trial name
- NCT00160316
- Testing
- 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
- Where
- 22 sites in Croatia, Poland and 2 more
- Volunteers
- 454 people
- Sponsor
- Solvay Pharmaceuticals
Glaucoma
AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure
The purpose of this study was to assess the safety and efficacy of switching to Azarga from prior pharmacotherapy in patients with open-angle glaucoma.
- Trial name
- NCT01484951
- Testing
- Brinzolamide 1% and timolol 0.5% fixed combination eye drops
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Alcon Research
Menopause, Bone Demineralization
A Study to Learn More About the Menopausal Hormone Therapies in Korea
The purpose of this study is to learn about how the commonly used menopausal hormone therapies were prescribed and taken in practice.
- Trial name
- NCT06033521
- Testing
- Menopausal hormone therapy Intervention Type: Drug
- Where
- South Korea
- Volunteers
- 1,036,294 people
- Sponsor
- Pfizer
Fabry Disease
Replagal Enzyme Replacement Therapy for Children With Fabry Disease
Primary Objective(s): To assess the safety of Replagal at a dose of 0.2 mg/kg administered over 40 (+/-10) minutes in children with Fabry disease To assess the effect of Replagal on heart rate variability in patients 7 to 17…
- Trial name
- NCT00084084
- Testing
- Agalsidase alfa
- Where
- 14 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- Shire
Smoking
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol).
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 Menthol (mTHS), a candidate Modified Risk Tobacco Product…
- Trial name
- NCT01967706
- Testing
- mTHS, mCC, NRT
- Where
- Japan
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Hypogonadism
Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure
To further characterize the transfer potential of marketed testosterone gel and new 1.62% formulation.
- Trial name
- NCT00998933
- Testing
- Testosterone gel 1.62%
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Solvay Pharmaceuticals
Late-onset Pompe Disease
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset Pompe Disease
This is a Phase 1, multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL952 in adult participants with late-onset Pompe disease.
- Trial name
- NCT07354724
- Testing
- DNL952
- Where
- 4 sites in United States
- Volunteers
- 32 people
- Sponsor
- Denali Therapeutics Inc.
Fibrosing Colonopathy
Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)
This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of…
- Trial name
- NCT01652157
- Testing
- ULTRESA, PANCREAZE, CREON
- Where
- 123 sites in United States
- Volunteers
- 17 people
- Sponsor
- AbbVie
Smoking
Clinical Study of Smoke-Break Liquid Cigarettes
The purpose of this study is to determine whether the Smoke-Break nicotine delivery device can help smokers quit smoking, while avoiding many of the side effects associated with other smoking cessation products.
- Trial name
- NCT00715871
- Testing
- Nicotine, Smoke-Break nicotine delivery device
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Smoke-Break, Inc.
SMA - Spinal Muscular Atrophy, Gene Therapy
Gene Replacement Therapy Clinical Trial for Participants With Spinal Muscular Atrophy Type 1
Phase 3 pivotal US trial studying open-label intravenous administration of onasemnogene abeparvovec-xioi in spinal muscular atrophy (SMA) Type 1 participants.
- Trial name
- STR1VE (NCT03306277)
- Testing
- Onasemnogene Abeparvovec-xioi
- Where
- 16 sites in United States
- Volunteers
- 22 people
- Sponsor
- Novartis Gene Therapies
Primary Immune Deficiency Disorder
Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
The objective of this study is to assess the long-term safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06_002CR (NCT01199705).
- Trial name
- NCT01458171
- Testing
- Immune globulin subcutaneous (Human)
- Where
- 9 sites in Japan
- Volunteers
- 23 people
- Sponsor
- CSL Behring
Fabry Disease
A Study of Agalsidase Alfa Enyzme Replacement Therapy in Chinese Children and Adults With Fabry Disease
Fabry Disease is a rare blood disorder that some people are born with. People with Fabry disease have low levels of an enzyme called alpha-galactosidase A. This enzyme helps to cut down fat-like substances.
- Trial name
- NCT07187440
- Testing
- No intervention
- Where
- 18 sites in China
- Volunteers
- 200 people
- Sponsor
- Takeda
Fabry Disease
A Long Term Safety and Efficacy Study of Fabrazyme Replacement Therapy in Japanese Patients With Fabry Disease.
The purpose of this survey is to identify any concerns regarding the following efficacy and safety-related issues in clinical practice with the new drugs "Fabrazyme for intravenous infusion 5mg" and "Fabrazyme for intravenous…
- Trial name
- NCT00233870
- Testing
- Agalsidase beta (recombinant form)
- Where
- Japan
- Volunteers
- 405 people
- Sponsor
- Genzyme, a Sanofi Company
Mucopolysaccharidosis IVA, Morquio A Syndrome
Safety and Exercise Study of Two Doses of BMN 110 for Morquio A Syndrome
The primary objective of this study was to evaluate the safety of a 2.0 mg/kg/week and a 4.0 mg/kg/week of BMN 110 in patients with Morquio A syndrome for up to 196 weeks.
- Conditions
- Mucopolysaccharidosis IVA, Morquio A Syndrome, MPS IVA
- Trial name
- NCT01609062
- Testing
- BMN 110
- Where
- 11 sites in United States, Canada and 2 more
- Volunteers
- 25 people
- Sponsor
- BioMarin Pharmaceutical
Congenital Adrenal Hyperplasia
Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
This study is a randomized, double-blind, active-controlled, phase III study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16 years and over with Congenital Adrenal…
- Trial name
- CONnECT (NCT05063994)
- Testing
- Chronocort, Cortef
- Where
- 21 sites in United States, France and 1 more
- Volunteers
- 55 people
- Sponsor
- Neurocrine UK Limited
Glaucoma
Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Latin America
The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in participants with open-angle glaucoma or ocular hypertension.
- Trial name
- NCT01518244
- Testing
- Brinzolamide/timolol maleate fixed combination
- Volunteers
- 50 people
- Sponsor
- Alcon Research