| 1 |
NCT01771328 |
Recruiting |
Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia |
- Adrenal Hyperplasia, Congenital
|
- Drug: Hydrocortisone
- Drug: Cortisone acetate
|
Interventional |
Phase 2 |
- Haukeland University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Androgen levels
- Steroid metabolism
- bone metabolism
- (and 11 more...)
|
20 |
All |
18 Years to 60 Years (Adult) |
NCT01771328 |
2012/749 |
CAH |
February 2013 |
January 2017 |
January 2017 |
January 18, 2013 |
December 21, 2016 |
|
- Haukeland Universitetssykehus, Department of Medicine
Bergen, Norway
|
| 2 |
NCT03162172 |
Completed |
Growth Hormone (GH) in Congenital Adrenal Hyperplasia |
- Adrenal Hyperplasia, Congenital
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Adult height (AH) gain
- Number of treatment withdrawal due to adverse events
|
25 |
All |
18 Years to 50 Years (Adult) |
NCT03162172 |
CIC 2009-019 |
OPALE GH |
September 15, 2015 |
March 15, 2016 |
March 15, 2016 |
May 22, 2017 |
May 22, 2017 |
|
- Hospices Civils de Lyon
Lyon, France
|
| 3 |
NCT00694525 |
Unknown † |
Role of the Protein Osteoprotegerin in the Bone Health of Women With Congenital Adrenal Hyperplasia |
- Adrenal Hyperplasia, Congenital
|
|
Observational |
|
- Office of Rare Diseases (ORD)
|
NIH |
- Observational Model: Case Control
- Time Perspective: Cross-Sectional
|
- Comparison of levels of OPG
- Comparison of bone mineral density
|
40 |
Female |
20 Years to 35 Years (Adult) |
NCT00694525 |
RDCRN 5611 |
|
April 2008 |
June 2009 |
June 2009 |
June 10, 2008 |
June 2, 2009 |
|
- Mount Sinai School of Medicine
New York, New York, United States
|
| 4 |
NCT00529841 |
Completed |
Research Study for Children With Salt Wasting Congenital Adrenal Hyperplasia |
- Adrenal Hyperplasia, Congenital
|
- Drug: Hydrocortisone sodium acetate
|
Interventional |
Not Applicable |
- Baylor College of Medicine
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Serum 17-OHP concentration in the morning
- serum steroid hormone profiles
- serum blood glucose
- serum sodium
|
7 |
All |
3 Years to 18 Years (Child, Adult) |
NCT00529841 |
H-19704
GCRC # 0962 |
|
January 2007 |
September 2008 |
September 2008 |
September 14, 2007 |
September 14, 2015 |
|
- BCM, Texas Children's Hospital Clinic and General Clinical Research Center
Houston, Texas, United States
|
| 5 |
NCT00617292 |
Unknown † |
Determining the Long-Term Effects of Prenatal Dexamethasone Treatment in Children With 21-Hydroxylase Deficiency and Their Mothers |
- Adrenal Hyperplasia, Congenital
|
|
Observational |
|
- Office of Rare Diseases (ORD)
|
NIH |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Prevalence of hypertension and obesity
- "Normal" masculinization of unaffected females treated prenatally with dexamethasone
- Normal masculinization of male fetuses partially treated prenatally with dexamethasone
- Memory-related cognitive function
|
233 |
All |
12 Years and older (Child, Adult, Senior) |
NCT00617292 |
RDCRN 5610 |
|
January 2008 |
July 2009 |
July 2009 |
February 18, 2008 |
December 9, 2008 |
|
- Mount Sinai School of Medicine
New York, New York, United States - University of Texas Southwestern Medical Center
Dallas, Texas, United States - University of Sao Paolo
Sao Paolo, SP, Brazil - University of Lyon
Lyon, France
|
| 6 |
NCT00542841 |
Completed |
Examining Genetic Differences Among People With 21-Hydroxylase Deficiency |
- 21-hydroxylase Deficiency
|
- Procedure: Hydrocortisone withdrawal
|
Interventional |
Not Applicable |
- Maria I. New
- Office of Rare Diseases (ORD)
- National Center for Research Resources (NCRR)
- Icahn School of Medicine at Mount Sinai
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Serum 17-hydroxyprogesterone/cortisol ratio
- Many other serum and urine steroids, metabolites, and precursors
|
99 |
All |
18 Years to 50 Years (Adult) |
NCT00542841 |
RDCRN 5607
U54RR019484
RR019484 |
|
August 2007 |
March 2009 |
March 2009 |
October 12, 2007 |
December 14, 2015 |
|
- Mount Sinai School of Medicine
New York, New York, United States - University of Texas Southwestern Medical Center
Dallas, Texas, United States - University of Sao Paolo
Sao Paolo, SP, Brazil
|
| 7 |
NCT00621985 |
Completed
Has Results |
Dexamethasone Treatment of Congenital Adrenal Hyperplasia |
- Adrenal Hyperplasia, Congenital
|
- Drug: dexamethasone
- Drug: Hydrocortisone
|
Interventional |
Phase 2 |
- Boston Children’s Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percent Difference in the Mean Log Transformed Area Under the Curve of 17-hydroxyprogesterone Between Regimens
|
5 |
All |
2 Years to 9 Years (Child) |
NCT00621985 |
08-01-0025 |
|
April 2008 |
June 2009 |
June 2009 |
February 22, 2008 |
February 23, 2011 |
February 23, 2011 |
- Children's Hospital Boston
Boston, Massachusetts, United States
|
| 8 |
NCT01862380 |
Active, not recruiting |
Adrenocortical Functions in Women With Nonclassical 21-hydroxylase Deficiency. |
- Adrenal Hyperplasia, Congenital
- 21-hydroxylase Deficiency
|
- Other: Functional explorations
|
Interventional |
Not Applicable |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Maximal plasma cortisol concentration
- % of patients with maximal plasma cortisol concentration >=18microg/dl
- Maximal plasma ACTH concentration
- (and 4 more...)
|
41 |
Female |
18 Years to 50 Years (Adult) |
NCT01862380 |
P111005 |
EVAF-21 |
February 2013 |
December 2015 |
November 2016 |
May 24, 2013 |
September 29, 2016 |
|
- Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital
Le Kremlin-bicetre, France
|
| 9 |
NCT01495910 |
Completed |
A Study Examining Doses of Abiraterone Acetate in Adult Women With 21-Hydroxylase Deficiency |
- 21-hydroxylase Deficiency
|
- Drug: Abiraterone acetate
|
Interventional |
Phase 1 |
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The minimum dose of abiraterone acetate required to decrease serum androstenedione to the age-appropriate range for adult women with 21-hydroxylase deficiency
- Mean serum concentrations of androstenedione
- Mean serum concentrations of 17-hydroxyprogesterone
- (and 10 more...)
|
6 |
Female |
18 Years and older (Adult, Senior) |
NCT01495910 |
CR100007
212082HPL1002 |
|
December 2011 |
February 2013 |
February 2013 |
December 20, 2011 |
February 28, 2014 |
|
- Chicago, Illinois, United States
- Ann Arbor, Michigan, United States
- Dallas, Texas, United States
|
| 10 |
NCT02804178 |
Completed |
A Study of ATR-101 for the Treatment of Congenital Adrenal Hyperplasia |
- Congenital Adrenal Hyperplasia
|
|
Interventional |
Phase 2 |
- Millendo Therapeutics, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Reduction of 17-OHP to </= 2X ULN
- Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
- Pharmacokinetics: Area under the curve
- (and 2 more...)
|
15 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02804178 |
ATR-101-201 |
|
May 18, 2016 |
August 17, 2017 |
August 17, 2017 |
June 17, 2016 |
March 21, 2018 |
|
- Johns Hopkins University
Baltimore, Maryland, United States - National Institutes of Health Clinical Center
Bethesda, Maryland, United States - University of Michigan
Ann Arbor, Michigan, United States - (and 3 more...)
|
| 11 |
NCT01807364 |
Completed |
Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia |
- Congenital Adrenal Hyperplasia
|
|
Observational |
|
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Ultrasound evaluation of intima-media thickness
- Blood pressure
- Skin capillary density
- (and 9 more...)
|
170 |
All |
18 Years and older (Adult, Senior) |
NCT01807364 |
AOR 10032
P091106 |
cardiohcs |
May 2011 |
September 2015 |
April 2016 |
March 8, 2013 |
June 17, 2016 |
|
- Pitié Salpêtrière Hospital
Paris, France
|
| 12 |
NCT02349503 |
Withdrawn |
Safety, Pharmacokinetics and Pharmacodynamics of NBI-77860 in Adolescent Females With Congenital Adrenal Hyperplasia |
- Congenital Adrenal Hyperplasia
|
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants with adverse events following one oral dose of NBI-77860
- Area Under Concentration Curve (AUC) of NBI-77860 and its metabolites following one oral dose of NBI-77860
- Concentrations of 17-hydroxyprogesterone (17-OHP) following one oral dose of NBI-77860
- Concentrations of adrenocorticotropin hormone (ACTH) following one oral dose of NBI-77860
|
0 |
Female |
12 Years to 18 Years (Child, Adult) |
NCT02349503 |
NBI-77860-1401 |
|
February 2015 |
October 2015 |
October 2015 |
January 29, 2015 |
June 11, 2015 |
|
- Ann Arbor, Michigan, United States
- Seattle, Washington, United States
|
| 13 |
NCT03162159 |
Recruiting |
Adult Height Prediction in Congenital Adrenal Hyperplasia |
- Congenital Adrenal Hyperplasia
|
- Other: Collection of growth and bone maturation data
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
|
600 |
All |
18 Years to 40 Years (Adult) |
NCT03162159 |
CE-CIC-GREN-09-19 |
OPALE Model |
September 2010 |
December 2014 |
December 2018 |
May 22, 2017 |
May 22, 2017 |
|
- Hospices Civils de Lyon
Lyon, France
|
| 14 |
NCT02552251 |
Unknown † |
COrticosteroid in Congenital Adrenal Hyperplasia |
- Congenital Adrenal Hyperplasia
|
- Biological: Hormonal balance measurements
- Biological: metabolic balance measurements
- Biological: bone balance measurements
- Behavioral: quality of life assessment
|
Interventional |
Phase 2
Phase 3 |
- University Hospital, Caen
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- hormonal parameters
- parameters of bone turnover:
- metabolic parameters:
- Quality of Life
|
40 |
Female |
18 Years to 55 Years (Adult) |
NCT02552251 |
11-059 |
COCA |
August 2012 |
December 2015 |
|
September 17, 2015 |
September 17, 2015 |
|
- Service Endocrinologie et Maladies Métaboliques
Caen, France
|
| 15 |
NCT00749593 |
Completed |
Study of UK Adults With Congenital Adrenal Hyperplasia. |
- Congenital Adrenal Hyperplasia
|
|
Observational |
|
- Sheffield Teaching Hospitals NHS Foundation Trust
- Society for Endocrinology
- The Clinical Endocrinology Trust
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- The anthropometric, metabolic, endocrine and quality of life variables of adults with congenital adrenal Hyperplasia will be compared to reference ranges for the normal population.
- To identify areas where further research is required and to inform on the day to day management of adults with CAH
|
25 |
All |
18 Years to 65 Years (Adult) |
NCT00749593 |
CaHASE STH13503
MREC 04/07/013 |
CaHASE |
August 2004 |
June 2007 |
December 2011 |
September 9, 2008 |
June 11, 2012 |
|
- Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, United Kingdom
|
| 16 |
NCT03257462 |
Recruiting |
Study of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia |
- Congenital Adrenal Hyperplasia
- CAH - Congenital Adrenal Hyperplasia
|
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety of SPR001 in patients with CAH
- Change in 17-hydroxyprogesterone
- Changes in pharmacodynamic (PD) markers
- (and 3 more...)
|
18 |
All |
18 Years and older (Adult, Senior) |
NCT03257462 |
SPR001-201 |
|
July 26, 2017 |
June 2018 |
July 2018 |
August 22, 2017 |
October 17, 2017 |
|
- Spruce Biosciences Clinical Site
Orange, California, United States - Spruce Biosciences Clinical Site
San Diego, California, United States - Spruce Biosciences Clinical Site
Atlanta, Georgia, United States - (and 5 more...)
|
| 17 |
NCT02574910 |
Recruiting |
Androgen Reduction in Congenital Adrenal Hyperplasia, Phase 1 |
- Congenital Adrenal Hyperplasia
|
- Drug: Abiraterone acetate
|
Interventional |
Phase 1 |
- University of Texas Southwestern Medical Center
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- University of Michigan
- (and 2 more...)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Normalization of serum androstenedione level
- 17-hydroxyprogesterone levels
- Dihydrotestosterone levels
|
36 |
All |
2 Years to 9 Years (Child) |
NCT02574910 |
112014-087
1U01HD083493-01 |
|
August 1, 2017 |
August 2018 |
September 2018 |
October 14, 2015 |
August 4, 2017 |
|
- Children's Hospital of Los Angeles
Los Angeles, California, United States - National Institutes of Health
Bethesda, Maryland, United States - University of Michigan
Ann Arbor, Michigan, United States - (and 2 more...)
|
| 18 |
NCT02716818 |
Recruiting |
Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia |
- Congenital Adrenal Hyperplasia
|
- Drug: Chronocort®
- Drug: standard glucocorticoid therapy
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change from baseline in 17-OHP
- Change from baseline in A4
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- Use and reasons for use of rescue medication
|
110 |
All |
18 Years and older (Adult, Senior) |
NCT02716818 |
DIUR-005 |
|
February 22, 2016 |
April 2018 |
April 2018 |
March 23, 2016 |
July 17, 2017 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
| 19 |
NCT00559078 |
Completed |
Qualitative Research on Women With Congenital Adrenal Hyperplasia |
- Congenital Adrenal Hyperplasia
|
|
Observational |
|
|
Other |
- Time Perspective: Cross-Sectional
|
- Telephone interview consisting of approximately 7 open ended questions addressing domains of HRQL, Mental Health and Support
- Demographic Questionnaire
|
16 |
Female |
25 Years to 55 Years (Adult) |
NCT00559078 |
1-Malouf |
CAH |
July 2007 |
|
May 2009 |
November 16, 2007 |
November 9, 2009 |
|
- Lehigh University
Bethlehem, Pennsylvania, United States
|
| 20 |
NCT00151710 |
Completed |
Effects of Pioglitazone in Congenital Adrenal Hyperplasia |
- Congenital Adrenal Hyperplasia
|
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double
|
|
|
All |
18 Years and older (Adult, Senior) |
NCT00151710 |
H6E-UT-O013 |
|
|
|
|
September 9, 2005 |
March 1, 2007 |
|
- Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands
|
| 21 |
NCT02096510 |
Recruiting |
Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia |
- Addison Disease
- Adrenal Hyperplasia Congenital
|
- Drug: Solu-Cortef
- Drug: Cortef
|
Interventional |
Phase 1
Phase 2 |
- Haukeland University Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Serum cortisol -24 hours curve
- Salivary cortisol - 24 hours curve
- 24 h urine cortisol and metabolites
- (and 3 more...)
|
10 |
All |
18 Years to 65 Years (Adult) |
NCT02096510 |
2013/1738 |
|
August 2014 |
December 2017 |
December 2017 |
March 26, 2014 |
December 21, 2016 |
|
- University Hospital Helse Bergen
Bergen, Norway
|
| 22 |
NCT00011791 |
Completed |
Catecholamine Reserve and Exercise Tolerance in Healthy Volunteers and Patients With Congenital Adrenal Hyperplasia |
- Congenital Adrenal Hyperplasia
- Healthy
|
|
Observational |
|
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
61 |
All |
9 Years to 40 Years (Child, Adult) |
NCT00011791 |
010096
01-CH-0096 |
|
February 22, 2001 |
|
May 10, 2011 |
March 1, 2001 |
July 2, 2017 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 23 |
NCT02795871 |
Recruiting |
Prenatal Dex Study |
- Congenital Adrenal Hyperplasia
|
- Behavioral: Neuropsychological and cognitive assessment
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Intelligence quotient
- Children Memory Scale (CMS)
- Rey figure test
- (and 4 more...)
|
500 |
All |
6 Years to 15 Years (Child) |
NCT02795871 |
69HCL14_0447 |
Prenatal Dex |
October 2016 |
December 2018 |
December 2019 |
June 10, 2016 |
February 23, 2017 |
|
- Groupement Hospitalier Est - Laboratoire d'endocrinologie moléculaire et maladies rares - Centre de biologie et de pathologie Est. 59 boulevard Pinel
Bron, France
|
| 24 |
NCT00001521 |
Completed |
Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia |
- Congenital Adrenal Hyperplasia
- Growth Disorder
|
- Drug: Flutamide and Testolactone
- Drug: Deslorelin
|
Interventional |
Phase 1 |
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Primary Purpose: Treatment
|
|
62 |
All |
2 Years to 20 Years (Child, Adult) |
NCT00001521 |
960033
96-CH-0033 |
|
February 2, 1996 |
|
January 11, 2017 |
November 4, 1999 |
April 24, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 25 |
NCT03062280 |
Recruiting |
A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH |
- Congenital Adrenal Hyperplasia
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety and tolerability of Chronocort, as assessed by the incidence of treatment-emergent adverse events
- Safety and tolerability of Chronocort, as assessed by clinical observation.
- Safety and tolerability of Chronocort, as assessed by laboratory measures.
- (and 3 more...)
|
110 |
All |
18 Years and older (Adult, Senior) |
NCT03062280 |
DIUR-006 |
|
August 18, 2016 |
August 2018 |
August 2018 |
February 23, 2017 |
July 19, 2017 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
| 26 |
NCT00000102 |
Completed |
Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets |
- Congenital Adrenal Hyperplasia
|
|
Interventional |
Phase 1
Phase 2 |
- National Center for Research Resources (NCRR)
|
NIH |
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
|
|
All |
14 Years to 35 Years (Child, Adult) |
NCT00000102 |
NCRR-M01RR01070-0506
M01RR001070 |
|
|
|
|
November 4, 1999 |
June 24, 2005 |
|
- Medical University of South Carolina
Charleston, South Carolina, United States
|
| 27 |
NCT00519818 |
Completed
Has Results |
Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia |
- Congenital Adrenal Hyperplasia
- 21-Hydroxylase Deficiency
- Adrenogenital Syndrome
|
- Drug: Chronocort
- Drug: Cortef
|
Interventional |
Phase 1
Phase 2 |
- Diurnal Limited
- National Institutes of Health Clinical Center (CC)
|
Industry / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Chronocort vs. Cortef Cortisol Concentrations (AUC Over 24 Hours - Time Points 0,.5,1,1.5,2,3,4,5,6,7,8,10,10.5,11, 11.5,12,13,15,17,17.5,18,18.5,19,20,22,24 Post Dose).
- 17 Hydroxyprogesterone at 08.00 Hours
|
20 |
All |
16 Years to 60 Years (Child, Adult) |
NCT00519818 |
070211 |
|
August 2007 |
May 2009 |
May 2009 |
August 23, 2007 |
March 24, 2016 |
August 27, 2014 |
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 28 |
NCT01859312 |
Completed
Has Results |
Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia |
- Adrenal Insufficiency
- Excess Androgen
- Congenital Adrenal Hyperplasia (CAH)
|
- Drug: Hydrocortisone (Solucortef)
- Device: Insulin pump (Medtronic)
|
Interventional |
Phase 2 |
- National Institutes of Health Clinical Center (CC)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Patients With 17-OHP Levels Equal or Below 1,200 ng/dL at 0700
- Number of Patients With 17-OH Progesterone Levels Equal or Below 1,200 ng/dL at 0700
- Participants Mean Level of 17-OHP at 0700
- (and 21 more...)
|
8 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT01859312 |
130121
13-CH-0121 |
|
May 6, 2013 |
December 2, 2016 |
December 2, 2016 |
May 21, 2013 |
December 22, 2017 |
November 22, 2017 |
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 29 |
NCT01313455 |
Completed |
Adrenal Hyperplasia Among Young People With PCOS |
- Adrenal Hyperplasia
- Polycystic Ovarian Syndrome
- Oligomenorrhea
- (and 2 more...)
|
|
Observational |
|
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Time Perspective: Prospective
|
|
96 |
Female |
16 Years to 29 Years (Child, Adult) |
NCT01313455 |
110119
11-CH-0119 |
|
March 10, 2011 |
|
October 24, 2017 |
March 11, 2011 |
October 26, 2017 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 30 |
NCT01184651 |
Completed |
Tweens to Teens Project at Penn State |
- Congenital Adrenal Hyperplasia
|
- Behavioral: Questionnaires/Interviews
|
Observational |
|
- Penn State University
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
|
188 |
Female |
10 Years to 13 Years (Child) |
NCT01184651 |
PSU ORP#30695
1R01HD057930-01A1 |
T2T@PSU |
August 2009 |
July 2013 |
July 2013 |
August 19, 2010 |
January 8, 2018 |
|
- The Pennsylvania State University, Dept. of Psychology - Tweens to Teens Project
University Park, Pennsylvania, United States
|
| 31 |
NCT02810496 |
Recruiting |
Mutations of Glucocorticoid Receptor in Bilateral Adrenal Hyperplasia |
- General Glucocorticoid Resistance
|
- Genetic: blood collection for mutation characterization
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
|
150 |
All |
18 Years and older (Adult, Senior) |
NCT02810496 |
PN11010 |
MUTA-GR |
April 2012 |
December 2016 |
|
June 23, 2016 |
June 23, 2016 |
|
- Chu Reims
France, Reims, France
|
| 32 |
NCT01735617 |
Completed
Has Results |
Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH |
- Endocrine Disease
- Adrenal Insufficiency
- Congenital Adrenal Hyperplasia
|
- Drug: Hydrocortisone Modified Release Capsules
|
Interventional |
Phase 2 |
- Diurnal Limited
- National Institutes of Health (NIH)
|
Industry / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pharmacokinetic Profile (Cmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
- Pharmacokinetic Profile (AUC0-24) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
- Pharmacokinetic Profile (Tmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
- (and 7 more...)
|
16 |
All |
18 Years and older (Adult, Senior) |
NCT01735617 |
DIUR-003 |
|
December 2012 |
December 2013 |
December 2013 |
November 28, 2012 |
May 17, 2017 |
May 17, 2017 |
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
| 33 |
NCT03019614 |
Completed |
An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone |
- Congenital Adrenal Hyperplasia
- Adrenal Insufficiency
|
- Drug: Hydrocortisone
- Drug: Chronocort
|
Interventional |
Phase 1 |
- Diurnal Limited
- Simbec Research
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Derived pharmacokinetic parameter: Tmax
- Derived pharmacokinetic parameter: Tlag
- Derived pharmacokinetic parameter: Cmax
- (and 4 more...)
|
30 |
Male |
18 Years to 60 Years (Adult) |
NCT03019614 |
DIUR-001 |
|
March 2010 |
April 2010 |
April 2010 |
January 12, 2017 |
January 12, 2017 |
|
|
| 34 |
NCT03051893 |
Completed |
A Two-part, Study to Compare the Pharmacokinetics and Dose Proportionality of up to 6 Chronocort Formulations |
- Adrenal Insufficiency
- Congenital Adrenal Hyperplasia
|
|
Interventional |
Phase 1 |
- Diurnal Limited
- Simbec Research
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To compare the Tmax of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period. Parts A1 & A2 only
- To compare the Cmax of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period. Parts A1 & A2 only
- To compare the AUC0-t of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period.
- (and 2 more...)
|
28 |
Male |
18 Years to 60 Years (Adult) |
NCT03051893 |
DIUR-002 |
|
February 2011 |
April 2012 |
April 2012 |
February 14, 2017 |
February 14, 2017 |
|
|
| 35 |
NCT01488721 |
Completed |
Clinical Evaluation of NeoPlex4 Assay and NeoPlex System |
- Adrenal Hyperplasia, Congenital
- Congenital Hypothyroidism
- Cystic Fibrosis
|
|
Observational |
|
- Luminex Corporation
- Luminex Molecular Diagnostics
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
|
7462 |
All |
up to 7 Days (Child) |
NCT01488721 |
CLD-0001 |
|
December 2011 |
February 2012 |
April 2012 |
December 8, 2011 |
August 17, 2012 |
|
- New York State Department of Health
Albany, New York, United States - Tennessee Department of Health
Nashville, Tennessee, United States - Unified State Laboratories: Public Health
Taylorsville, Utah, United States
|
| 36 |
NCT00250159 |
Enrolling by invitation |
Natural History Study of Patients With Excess Androgen |
- Congenital Adrenal Hyperplasia (CAH)
- Familial Male-Limited Precocious Puberty (FMPP)
|
|
Observational |
|
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- To elucidate a comprehensive phenotypic profile for patients with CAH and FMPPi
|
741 |
All |
up to 80 Years (Child, Adult, Senior) |
NCT00250159 |
060011
06-CH-0011 |
|
November 3, 2005 |
|
|
November 7, 2005 |
April 19, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 37 |
NCT00172510 |
Unknown † |
Mutation Analysis of 17α-Hydroxylase |
- Pseudohermaphroditism
- Congenital Adrenal Hyperplasia
- Hypertension
|
|
Observational |
|
- National Taiwan University Hospital
|
Other |
- Observational Model: Defined Population
- Primary Purpose: Screening
- Time Perspective: Cross-Sectional
- Time Perspective: Retrospective
|
|
25 |
All |
Child, Adult, Senior |
NCT00172510 |
9361701060 |
|
August 2004 |
|
August 2005 |
September 15, 2005 |
September 15, 2005 |
|
- National Taiwan University Hospital
Taipei, Taiwan
|
| 38 |
NCT03174847 |
Recruiting |
Prospective Study Assessing Blood Pressure and Other Outcomes Post-treatment in Patients With Primary Aldosteronism |
- Primary Aldosteronism
- Primary Aldosteronism Due to Aldosterone Producing Adenoma
- Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
|
- Procedure: Adrenalectomy
- Drug: Mineralocorticoid Receptor Antagonists
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Blood Pressure
- Use of antihypertension medications
- Cardiac function
- (and 12 more...)
|
50 |
All |
21 Years to 80 Years (Adult, Senior) |
NCT03174847 |
PA_PACES
CHF2016.02-P |
PA_PACES |
February 20, 2017 |
January 30, 2019 |
January 30, 2020 |
June 5, 2017 |
June 5, 2017 |
|
- Changi General Hospital
Singapore, Singapore
|
| 39 |
NCT01875640 |
Completed |
Decision Support for Parents Receiving Information About Child's Rare Disease |
- Disorder of Sex Development
- Intersex Conditions
- Congenital Adrenal Hyperplasia
- Hypospadias
|
|
Observational |
|
- University of Michigan
- Patient-Centered Outcomes Research Institute
- Virginia Commonwealth University
- (and 3 more...)
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
|
63 |
All |
Child, Adult, Senior |
NCT01875640 |
1360
13-PAF00134
HUM72007 |
DSD DST |
June 2013 |
May 2016 |
December 2017 |
June 12, 2013 |
February 20, 2018 |
|
- University of California Los Angeles
Los Angeles, California, United States - University of Michigan
Ann Arbor, Michigan, United States - Temple University
Philadelphia, Pennsylvania, United States - Seattle Children's Hospital
Seattle, Washington, United States
|
| 40 |
NCT02733367 |
Active, not recruiting |
Extension Study for Patients Entered Into Study Infacort 003 |
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of serious adverse events (SAEs) and adverse events (AEs)
- Growth velocity
- Cortisol levels
|
24 |
All |
up to 6 Years (Child) |
NCT02733367 |
Infacort 004 |
|
March 4, 2016 |
August 2018 |
August 2018 |
April 11, 2016 |
November 9, 2017 |
|
- Charité-Universitätsmedizin Berlin, CVK
Berlin, Germany
|
| 41 |
NCT02934399 |
Recruiting |
Dynamic Hormone Diagnostics in Endocrine Disease |
- Adrenal Insufficiency
- Congenital Adrenal Hyperplasia
- Cushing Syndrome
- (and 3 more...)
|
- Other: 27 hour subcutaneous fluid sampling
|
Observational |
|
- Haukeland University Hospital
- Karolinska Institutet
- University Hospitals Bristol NHS Foundation Trust
- Evaggelismos Hospital, Greece
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- steroids
- androgens
- mineralocorticoids
- (and 13 more...)
|
350 |
All |
18 Years to 68 Years (Adult, Senior) |
NCT02934399 |
REKno 2015/872 |
ultradian |
October 2016 |
September 2019 |
September 2019 |
October 17, 2016 |
February 23, 2018 |
|
- Evangelissmos hospital
Athen, Greece - Haukeland University Hospital
Bergen, Norway - Karolinska Institutet
Stockholm, Sweden - Bristol University hospital
Bristol, United Kingdom
|
| 42 |
NCT00485186 |
Withdrawn |
Gene Polymorphisms Influencing Steroid Synthesis and Action |
- Disorders of Sex Development
- Congenital Adrenal Hyperplasia
- Congenital Adrenal Hypoplasia
- (and 3 more...)
|
|
Observational |
|
- University of Schleswig-Holstein
|
Other |
- Observational Model: Family-Based
- Time Perspective: Prospective
|
|
0 |
All |
Child, Adult, Senior |
NCT00485186 |
D429/05 |
|
June 2007 |
June 2013 |
June 2013 |
June 12, 2007 |
September 5, 2013 |
|
|
| 43 |
NCT01567111 |
Active, not recruiting |
11C-Metomidate PET Versus Adrenal Vein Sampling in Primary Aldosteronism |
- Primary Hyperaldosteronism
|
- Procedure: 11C-Metomidate Positron Emission Tomography
|
Interventional |
Not Applicable |
- Helsinki University Central Hospital
- Turku University Hospital
- University of Tampere
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET)
- Blood pressure response
|
40 |
All |
20 Years to 65 Years (Adult) |
NCT01567111 |
T79/2011 |
MIA |
February 2012 |
August 2015 |
December 2022 |
March 30, 2012 |
March 1, 2017 |
|
- Helsinki University Central Hospital
Helsinki, Finland - Tampere University
Tampere, Finland - University of Turku
Turku, Finland
|
| 44 |
NCT03188640 |
Completed |
Bariatric Surgery, Hormones, and Quality of Life |
- Obesity
- Hormone Disturbance
- Quality of Life
- Hyperandrogenism
|
- Procedure: Laparoscopic gastric-bypass surgery
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Sex-hormone levels
- Female sexual function
- Hormone-related quality of life
- (and 2 more...)
|
68 |
Female |
18 Years to 50 Years (Adult) |
NCT03188640 |
2012/392-31 |
OBLIV |
March 1, 2014 |
October 31, 2016 |
October 31, 2016 |
June 15, 2017 |
June 16, 2017 |
|
|
| 45 |
NCT01661387 |
Recruiting |
A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI) |
- Chronic Adrenal Insufficiency
|
|
Observational |
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Incidence of intercurrent illness
- Incidence of adrenal crisis
- Incidence of serious adverse events
|
3000 |
All |
Child, Adult, Senior |
NCT01661387 |
Protocol 0918-400 |
|
August 2012 |
August 2019 |
August 2019 |
August 9, 2012 |
January 27, 2017 |
|
- Charité - Universitätsmedizin Berlin
Berlin, Germany - Endokrinologiepraxis am Stuttgarter Platz
Berlin, Germany - Friedrich Alexander Universitat Erlangen Nurnberg
Erlangen, Germany - (and 21 more...)
|
| 46 |
NCT01234220 |
Completed |
Adrenal Vein Sampling International Study (AVIS Study) |
|
|
Observational |
|
- University Hospital Padova
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Number of adrenal vein ruptures occurring during AVS
- AVS cost for the patient and the health insurance system
- number of selective AVS at right or left side
- (and 2 more...)
|
2604 |
All |
18 Years and older (Adult, Senior) |
NCT01234220 |
GPR-AVIS |
AVIS |
May 2010 |
June 2011 |
November 2011 |
November 4, 2010 |
January 15, 2013 |
|
- Hospital of The University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, United States - UT Southwestern Medical Center
Dallas, Texas, United States - Medical College of Wisconsin
Menomonee Falls, Wisconsin, United States - (and 17 more...)
|
| 47 |
NCT02155933 |
Recruiting |
Assessment of Day-night Secretion of Progesterone and LH Across Puberty |
|
|
Observational |
|
- University of Virginia
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Observational Model: Case-Control
- Time Perspective: Cross-Sectional
|
- Difference in mean LH frequency when awake (19:00-23:00 and 07:00-11:00) and when asleep (23:00-07:00) in girls with and without hyperandrogenemia
- Daytime (awake) and nighttime (sleep) differences in hormones (LH, FSH, T, E2, P, and cortisol) in girls with and without hyperandrogenemia
|
75 |
Female |
7 Years to 17 Years (Child) |
NCT02155933 |
13502
P50HD028934 |
LH |
February 2008 |
February 2019 |
February 2019 |
June 4, 2014 |
April 12, 2018 |
|
- Center for Research in Reproduction, University of Virginia
Charlottesville, Virginia, United States
|
| 48 |
NCT03252223 |
Recruiting |
Ovarian Response to Recombinant Follicle Stimulating Hormone in Women With PCOS |
- Polycystic Ovary Syndrome
- Healthy
- Anovulation
- Hyperandrogenism
|
- Drug: Recombinant Follicle Stimulating Hormone
|
Interventional |
Phase 4 |
- University of California, San Diego
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Change in granulosa cell function in 24 hours intervals following FSH administration
- Change in follicle count in following FSH administration
- Change in follicular size in following FSH administration
|
42 |
Female |
18 Years to 37 Years (Adult) |
NCT03252223 |
170684 |
|
October 2, 2017 |
August 31, 2019 |
October 1, 2019 |
August 17, 2017 |
September 26, 2017 |
|
- University of California, San Diego
La Jolla, California, United States
|
| 49 |
NCT03088046 |
Completed |
Circulating Androgen Levels Are Not Affected by the Administration of Vaginal Micronized Progesterone for Withdrawal Bleeding in Patients With Polycystic Ovarian Syndrome |
- Anovulation
- Polycystic Ovary Syndrome
- Hyperandrogenism
|
- Drug: Micronized Progesterone
|
Interventional |
Not Applicable |
- Institut Universitari Dexeus
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Change in Total testosterone (TT)
- Change in free testosterone (FT)
- Change in sex hormone binding globulin (SHBG)
- (and 3 more...)
|
15 |
Female |
18 Years to 35 Years (Adult) |
NCT03088046 |
SMD-2017-02 |
|
February 2014 |
February 2015 |
February 2015 |
March 23, 2017 |
March 23, 2017 |
|
|
| 50 |
NCT02651636 |
Completed |
Combined Therapy With Myo-inositol and Alpha-Lipoic Acid in PCOS Women |
- Polycystic Ovary Syndrome
- Menstrual Pattern
- Hyperandrogenism
- Metabolic Features
|
- Drug: myo-inositol,alpha-lipoic acid and folic acid
|
Interventional |
Not Applicable |
- Catholic University of the Sacred Heart
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of cycles in six months of therapy
- Hirsutism
- Hyperandrogenism
- (and 2 more...)
|
40 |
Female |
18 Years to 35 Years (Adult) |
NCT02651636 |
000102014 |
|
June 2014 |
July 2015 |
|
January 11, 2016 |
January 11, 2016 |
|
|
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