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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)

NCTNCT03695237 (opens ClinicalTrials.gov in a new tab)Other idM16-904
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
45 participants (actual)
Sponsor
AbbVie · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
2 countries

United States, Puerto Rico

Start
24 Oct 2018
Primary completion
6 May 2021
Completion
29 Nov 2023
First posted
4 Oct 2018
Last update posted
29 May 2024
Conditions
Central Precocious Puberty (CPP)

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018201920202021202220232024
  1. Ph 3

    A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)

    NCT03695237

    24 Oct 2018 to 29 Nov 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The primary objective of the study is to assess the safety and efficacy of a leuprolide acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have been previously treated with a GnRHa.

Interventions

  • Leuprolide Acetate (LA)Drug

Arms1

  • Experimental

    Leuprolide Acetate (LA)

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

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

    Registry description

    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 outcomes(9)

  1. 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

    Time frame · 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.

    Registry description

    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.

  2. Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48

    Time frame · Weeks 12, 20, 24, 44, and 48

    Registry description

    Estradiol concentrations were measured from blood samples taken at each study visit prior to stimulation testing (and prior to study drug administration at Weeks 24 and 48).

  3. Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48

    Time frame · Weeks 12, 20, 24, 44, and 48

    Registry description

    Testosterone concentrations were measured from blood samples taken at each study visit prior to stimulation testing (and prior to study drug administration for Weeks 24 and 48).

  4. Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty

    Time frame · Part 1: Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144

    Registry description

    Breast development in females and testicular volume or genital development in males was assessed using modified Tanner staging, on a scale from Stage 1 (prepubertal) to Stage 5 (adult characteristics). Females: Suppression is defined as regression or no progression of breast development according to modified Tanner staging. Males: Suppression is defined as regression or no progression in testicular volume and genital staging according to modified Tanner staging.

  5. Parts 1 and 2: Change From Baseline in Incremental Growth Rate

    Time frame · Part 1: Baseline and Weeks 4, 12, 20, 24, 44, and 48; Part 2: Weeks 72, 96, 120, and 144

    Registry description

    Growth rate (height in centimeter/year) was calculated both prior to treatment in the study and during the study. For Baseline calculation a historical measurement of height at least 6 months prior to Screening and the Screening value was used.

  6. Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age

    Time frame · Part 1: Baseline and Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144

    Registry description

    Bone age was assessed from radiographs of the hand and wrist by a central imaging vendor using the BoneXpert automated system. A ratio less than 1 indicates less advancement of bone age compared to chronological age.

  7. Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL)

    Time frame · Weeks 72, 96, 120, and 144

    Registry description

    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.

  8. Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL

    Time frame · Weeks 72, 96, 120, and 144

    Registry description

    Estradiol concentrations were measured from blood samples taken at each study visit prior to stimulation testing.

  9. Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL

    Time frame · Weeks 72, 96, 120, and 144

    Registry description

    Male participants with maintenance of suppression of testosterone to \< 30 ng/dL are assessed

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

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

GroupValue (percentage of participants)
Leuprolide Acetate - Previously Treated94.4
Leuprolide Acetate - Treament Naïve81.5
Leuprolide Acetate - Overall86.7
Secondary and other outcome results(7)
Secondary outcomeNumber· 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 Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48

GroupValue (percentage of participants)
Leuprolide Acetate - Previously Treated83.3
Leuprolide Acetate - Treament Naïve88.9
Leuprolide Acetate - Overall86.7
Secondary outcomeNumber· Weeks 12, 20, 24, 44, and 48

Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48

GroupValue (percentage of participants)
Leuprolide Acetate - Previously Treated100.0
Leuprolide Acetate - Treament Naïve95.5
Leuprolide Acetate - Overall97.4
Secondary outcomeNumber· 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

GroupValue (percentage of participants)
Leuprolide Acetate - Previously Treated100.0
Leuprolide Acetate - Treament Naïve100.0
Leuprolide Acetate - Overall100.0
Secondary outcomeNumber· Part 1: Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144

Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty

GroupValue (percentage of participants)
Leuprolide Acetate - Previously Treated94.1
Leuprolide Acetate - Treament Naïve91.7
Leuprolide Acetate - Overall92.7
Secondary outcomeMean· Part 1: Baseline and Weeks 4, 12, 20, 24, 44, and 48; Part 2: Weeks 72, 96, 120, and 144

Parts 1 and 2: Change From Baseline in Incremental Growth Rate

GroupValue (cm/year)Spread
Leuprolide Acetate - Previously Treated-0.69.99
Leuprolide Acetate - Treament Naïve-0.910.52
Leuprolide Acetate - Overall-0.810.19
Secondary outcomeMean· Part 1: Baseline and Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144

Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age

GroupValue (ratio)Spread
Leuprolide Acetate - Previously Treated0.50.80
Leuprolide Acetate - Treament Naïve0.70.56
Leuprolide Acetate - Overall0.60.66
Secondary outcomeNumber· Weeks 72, 96, 120, and 144

Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL)

GroupValue (percentage of participants)
Leuprolide Acetate - Previously Treated88.2
Leuprolide Acetate - Treament Naïve96.2
Leuprolide Acetate - Overall93.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Leuprolide Acetate - Previously TreatedParticipants who had been previously treated with a GnRHa for at least 6 months prior to enrollment received leuprolide acetate (LA) 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1 and for up to an additional 96 weeks in Part 2.0 / 180 / 1818 / 18
Leuprolide Acetate - Treament NaïveParticipants without previous GnRHa treatment prior to enrollment (treatment naïve) received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1 and for up to an additional 96 weeks in Part 2.0 / 271 / 2727 / 27

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 2 Years up to 11 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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 age). * No history of clinically significant medical conditions or any other reason that the investigator determines would make the participant an unsuitable candidate to receive study drug.

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