Phase 3 N=37 Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty
Precocious Puberty
Primary: Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L — 31; 6; 31; 3 participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=64 Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
Precocious Puberty, Central
Primary: Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months. — 54 Participants
Phase 4 N=79 A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty
Central Precocious Puberty
Primary: Percentage of Participants With Peak Luteinizing Hormone (LH) Suppression in Gonadotropin-Releasing Hormone (GnRH) Stimulation at Week 24 — 97.47 percentage of…
Phase 3 N=35 Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study
Precocious Puberty
Primary: Percentage of Children With a Stabilisation or Regression of Tanner Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and…
Phase 3 N=55 Study of Lupron Depot In The Treatment of Central Precocious Puberty
Puberty, Precocious
Primary: Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) — 81.8; 80.9; 87.8; 82.8…
Phase 3 N=50 The Adrenal Contribution to Androgen Production in Girls During Puberty
Development
Primary: 17-hydroxyprogesterone Response to ACTH — 2.4; 3.7; 3.1; 2.9 ng/mL
N/A N=1,957 The COPENHAGEN Puberty Study
Puberty
Primary: Pubertal Onset — 9.86; 9.86; 11.66; 11.66 years
Phase 3 N=66 A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.
Central Precocious Puberty
Primary: Percentage of Participants With Luteinising Hormone (LH) Suppression — 100 percentage of participants
Phase 3 N=84 A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty
Puberty, Precocious
Primary: Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 6 — 76.2; 80.7; 90.5; 100 Percentage of…
Phase 3 N=72 Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty
Precocious · Leuprolide Acetate · Luteinizing Hormone (LH)
Primary: Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone — 96.9; 100.0; 93.8; 100.0 percentage of participants
Phase 4 N=104 The Health Influences of Puberty (HIP) Study
Obesity · Insulin Resistance · Gonadal Dysfunction
Primary: Insulin Sensitivity — 8.559; 3.425; 3.756; 2.985 x10-4/min-1/mIU/mL
Phase 3 N=44 Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty
Central Precocious Puberty
Primary: Percentage of Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6 — 93.18 percentage of…
Phase 4 N=307 A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants
Central Precocious Puberty
Primary: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) — 252 participants
Phase 3 N=36 Histrelin Subcutaneous Implant in Children With Central Precocious Puberty
Central Precocious Puberty
Primary: Luteinizing Hormone (LH) — 0.88; 0.53; 0.07; 0.50 MIU/ML
Phase 3 N=32 Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty.
Central Precocious Puberty
Primary: Percentage of Participants With Luteinising Hormone (LH) Suppression After Gonadotropin-Releasing Hormone (GnRH) Stimulation — 100 percentage of participants
Phase 3 N=24 Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)
PCOS
Primary: 17OHP Levels After hCG — 3.2; 1.3 ng/ml
Phase 3 N=45 A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
Central Precocious Puberty (CPP)
Primary: Percentage of Participants With Suppression of Peak Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24…
Phase 3 N=39 LutrePulse Hypogonadotropic Hypogonadism
Primary Amenorrhea With Hypogonadotropic Hypogonadism
Primary: Ovulation Rate — 1; 4; 5; 9 Participants — p=0.0120
Early Phase 1 N=6 Investigation of Female Reproductive Hormone Dynamics During Adolescence
Menstruation Disturbances
Primary: Ovulation in Cycle 2 — 3; 2 Participants
Phase 3 N=76 Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature
Idiopathic Short Stature
Primary: Change in Height — 14; 17.1; 18.9 Centimeters — p=<0.006
Phase 2 N=14 Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis]
Puberty, Precocious
Primary: Change in Growth Rate (cm/Year) — -1.62 cm/year — p=0.278
N/A N=108 A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants
Central Precocious Puberty
Primary: Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase — 4; 71; 0; 2 Participants
N/A N=25 Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone
Polycystic Ovary Syndrome · Hyperandrogenism
Primary: Change in Progesterone Sensitivity Index Before and After Metformin Treatment. — -4.12; -4.29 % change in LH pulses/day 7 P4 level
Phase 3 N=91 Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature
Idiopathic Short Stature (ISS)
Primary: Number of Participants With One or More Drug-related Adverse Events — 42; 38; 11; 9 participants
N/A N=70 Intrauterine Environment in Polycystic Ovary Syndrome (PCOS) Probands
Polycystic Ovary Syndrome
Primary: Estradiol Level in Female Offspring — 18606; 6467 pg/ml — p=0.049
Phase 3 N=43 Genotropin Treatment In Very Young Children Born Small For Gestational Age
Infant, Small for Gestational Age
Primary: Change From Baseline in Height Standard Deviation Score (SDS) at Month 24. — 1.63; 0.43 SDS — p=<0.001
Phase 3 N=208 Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
Growth Disorders · Intrauterine Growth Retardation
Primary: Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm — 3.07; 3.97; 2.84 cm/year — p=0.02922