Clinical trials: 21-OHD
Disorder of Sex Development, Intersex Conditions
Decision Support for Parents Receiving Information About Child's Rare Disease
The birth of a child with a disorder of sex development (DSD) is stressful for parents and members of the healthcare team. The "right" decisions about gender assignment (is it a boy? a girl?) and the best course of action (e.g.…
- Conditions
- Disorder of Sex Development, Intersex Conditions, Congenital Adrenal Hyperplasia, Hypospadias
- Trial name
- DSD DST (NCT01875640)
- Where
- 4 sites in United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Congenital Adrenal Hyperplasia
Long-term Safety Study of Chronocort in the Treatment of Participants With Congenital Adrenal Hyperplasia
This phase III study is an open-label extension study to be conducted at approximately 21 investigational sites across 3 countries.
- Trial name
- NCT05299554
- Testing
- Chronocort
- Where
- 21 sites in United States, France and 1 more
- Volunteers
- 76 people
- Sponsor
- Immedica Pharma AB
Polycystic Ovary Syndrome (PCOS), Metabolic Dysfunction-Associated Steatotic Liver Disease
Biomarker Panel for PCOS-Associated Liver Steatosis in Adolescent Girls (COMPASS-pedPCOS)
This single-center, prospective, observational, cross-sectional mechanistic pilot study will evaluate whether polycystic ovary syndrome (PCOS) contributes to hepatic steatosis in adolescent girls independently of adiposity.
- Conditions
- Polycystic Ovary Syndrome (PCOS), Metabolic Dysfunction-Associated Steatotic Liver Disease, Pediatric Obesity, Hyperandrogenism
- Trial name
- COMPASSpedPCOS (NCT07731373)
- Testing
- Extended Serum Biomarker and Hormonal Panel, Liver Elastography with Controlled Attenuation Parameter, Targeted Genotyping of PNPLA3 rs738409 and HSD17B13 rs72613567
- Where
- Turkey (Türkiye)
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Kayseri City Hospital
CAH - Congenital Adrenal Hyperplasia
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal Hyperplasia
This is a Phase 2, open-label, multiple-dose, study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-74788 (crinecerfont) in pediatric participants (14 to 17 years of age) with a…
- Trial name
- NCT04045145
- Testing
- Crinecerfont
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Neurocrine Biosciences
Congenital Adrenal Hyperplasia
Tweens to Teens Project at Penn State
The goal of this study is to help investigators to understand more about the development of characteristics related to being male or female (what is called gender development).
- Trial name
- T2T@PSU (NCT01184651)
- Testing
- Questionnaires/Interviews
- Where
- United States
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- Penn State University
Congenital Adrenal Hyperplasia, CAH - Congenital Adrenal Hyperplasia
Study of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia
This is a multicenter Phase 2, multiple dose, dose escalation study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SPR001 in adult patients with classic congenital adrenal hyperplasia (CAH).
- Trial name
- NCT03257462
- Testing
- SPR001
- Where
- 9 sites in United States
- Volunteers
- 24 people
- Sponsor
- Spruce Biosciences
Congenital Adrenal Hyperplasia
Safety, Pharmacokinetics and Pharmacodynamics of NBI-77860 in Adolescent Females With Congenital Adrenal Hyperplasia
This is a Phase 1, multicenter, open-label, single-dose study to evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-77860 in subjects with congenital adrenal hyperplasia (CAH).
- Trial name
- NCT02349503
- Testing
- NBI-77860
- Where
- 2 sites in United States
- Sponsor
- Neurocrine Biosciences
Amenorrhea, Dysmenorrhea
Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation
This is a Phase IV, randomized, double-blind, comparative study of the use of two preparations of ethinyl estradiol and cyproterone acetate in the treatment of menstrual irregularities of hyper-androgenic origin.
- Conditions
- Amenorrhea, Dysmenorrhea, Menstruation Disturbances, Hyperandrogenism
- Trial name
- NCT01103518
- Testing
- Ethinyl Estradiol + Cyproterone acetate
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- Fundação Educacional Serra dos Órgãos
Puberty, Hyperandrogenism
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
The purpose of this study is two-fold. (1) We will determine if in mid- to late pubertal girls without hyperandrogenism (HA), progesterone (P4) acutely reduces waking luteinizing hormone (LH) frequency to a greater extent than…
- Trial name
- CRM003 (NCT00929006)
- Testing
- Micronized progesterone suspension
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
An Extension Study to Evaluate Safety and Efficacy of Atumelnant in Participants With Congenital Adrenal Hyperplasia
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of atumelnant (CRN04894).
- Trial name
- CALM2-CAH (NCT06712823)
- Testing
- atumelnant (CRN04894)
- Where
- 13 sites in United States, Argentina and 4 more
- Volunteers
- 200 people
- Sponsor
- Crinetics Pharmaceuticals Inc.
General Glucocorticoid Resistance
Mutations of Glucocorticoid Receptor in Bilateral Adrenal Hyperplasia
As the investigators observed a case of glucocorticoid mutation revealed by incidentally discovered bilateral adrenal nodular hyperplasia, it was postulated that this molecular anormality could be more frequent than previously…
- Trial name
- MUTA-GR (NCT02810496)
- Testing
- blood collection for mutation characterization
- Where
- France
- Volunteers
- 150 people
- Sponsor
- CHU de Reims
Congenital Adrenal Hyperplasia
Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21α-hydroxylase Deficiency
The purpose of this study is to conduct an open, randomized controlled clinical trial, evaluating the effects of different dosage forms of glucocorticoid on the Recovery of Reproductive Function in Patients With 21α-hydroxylase…
- Trial name
- CGP21 (NCT04536662)
- Testing
- Hydrocortisone, Prednisone, Dexamethasone
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Anovulation, Hyperandrogenism
Whole Genome Analysis for the Detection of Key Genes in the Polycystic Ovary Syndrome
Background: Infertility affects up to 15% of married couples. About half are attributable to female factors, among which anovulation is the leading cause.
- Conditions
- Anovulation, Hyperandrogenism, Polycystic Ovary Syndrome, Single Nucleotide Polymorphism
- Trial name
- NCT00665171
- Where
- Israel
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Maaynei Hayesha Medical Center
Polycystic Ovary Syndrome, Hyperandrogenism
Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone
Many, but not all, girls with high levels of the male hormone testosterone go on to develop polycystic ovary syndrome (PCOS) as adults.
- Trial name
- NCT01427595
- Testing
- Metformin, Progesterone, estrace
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Virginia
Adrenal Insufficiency, Excess Androgen
Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia
Background: Congenital adrenal hyperplasia (CAH) is a genetic disorder of the adrenal gland. The adrenal gland is located in the abdomen and produces small amounts of hormones such as cortisol, aldosterone, and androgen.
- Conditions
- Adrenal Insufficiency, Excess Androgen, Congenital Adrenal Hyperplasia (CAH)
- Trial name
- NCT01859312
- Testing
- Hydrocortisone (Solucortef), Insulin pump (Medtronic)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
PCOS (Polycystic Ovary Syndrome), Obese Adolescents
Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)
This pilot randomized controlled study will plan to enroll 36 adolescent females with Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS) to evaluate the effectiveness and feasibility of a tailored…
- Conditions
- PCOS (Polycystic Ovary Syndrome), Obese Adolescents, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities, Overweight Adolescents
- Trial name
- Beef+ (NCT07780188)
- Testing
- Beef+
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Texas A&M University
Polycystic Ovary Syndrome (PCOS), Myo-inositol
Myo-Inositol and D-Chiro-Inositol for Menstrual Irregularities and Hormone Changes in Women With Polycystic Ovarian Syndrome
The goal of this clinical trial is to determine whether a combination of myo-inositol (MI) and D-chiro-inositol (DCI) with folic acid is more effective than placebo (Folic acid alone) in improving menstrual irregularities and…
- Conditions
- Polycystic Ovary Syndrome (PCOS), Myo-inositol, D-chiro-inositol
- Trial name
- NCT07701525
- Testing
- Myo-Inositol and D-Chiro-Inositol Combination Therapy
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Nishtar Medical University
Hyperandrogenism
Sleep-wake Changes of Luteinizing Hormone Frequency in Pubertal Girls With and Without High Testosterone
The purpose of this study is to determine whether sleep-wake changes of luteinizing hormone pulse frequency are different in early pubertal girls with high testosterone levels compared to early pubertal girls with normal…
- Trial name
- CRM005 (NCT00930007)
- Testing
- Blood sampling
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Polycystic Ovary Syndrome
Effects of Metformin and Oral Hormonal Contraceptive in Adolescents With Polycystic Ovary Syndrome
The polycystic ovary syndrome is the most common endocrinopathy in reproductive age women. The pathophysiology of this syndrome remains unclear, but there are evidences that a decreased in insulin sensitivity may be related in…
- Trial name
- NCT00988078
- Testing
- Metformin
- Where
- Brazil
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Federal University of São Paulo
Congenital Adrenal Hyperplasia, 21-Hydroxylase Deficiency
Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia
This study will test a new, extended release form of hydrocortisone called Chronocort in patients with congenital adrenal hyperplasia (CAH).
- Conditions
- Congenital Adrenal Hyperplasia, 21-Hydroxylase Deficiency, Adrenogenital Syndrome
- Trial name
- NCT00519818
- Testing
- Chronocort, Cortef
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Neurocrine UK Limited