Recent Updates
Recently added Catalysts

Leuprolide/ML

Phase 3

Central Precocious Puberty (CPP) | Small molecule | Endocrine |AbbVie Inc.|Last Updated: May 29, 2024

Target and mechanism

ModalitySmall molecule

Also known as Leuprolide Acetate (LA), Leuprolide

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

Leuprolide/ML · 1 trial · 1 indication

Phase 3 1
NCT03695237A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)Central Precocious Puberty (CPP)
COMPLETED45 Analytics
PHASE3COMPLETED
A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
Central Precocious Puberty (CPP)
NCT0369523745
Unlock trial analytics

Study Endpoints

Primary Endpoints

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
Week 24 (prior to the Week 24 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection.

Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg. Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test. Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL.

Secondary Endpoints

Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48
Weeks 12, 20, 44, and 48 (prior to Week 48 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection.
Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48
Weeks 12, 20, 24, 44, and 48
Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48
Weeks 12, 20, 24, 44, and 48
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Leuprolide Acetate (LA)EXPERIMENTALParticipants received leuprolide acetate (LA) 45 mg every 6 months administered as an intramuscular injection for up to 144 weeks.

Interventions

NameTypeDescription
Leuprolide Acetate (LA)DRUGAdministered intramuscularly as an injection
Unlock Study Design Details

Eligibility Criteria

Age Range2 Years to 11 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Children with CPP who are naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) (females 2 - 8 years of age, or males 2 - 9 years of age) or who have been on standard GnRHa therapy for at least 6 months (females 2 - 10 years of age, or males 2 - 11 years of ...

Countries:United StatesPuerto Rico
Unlock Eligibility Criteria