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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty

NCTNCT02452931 (opens ClinicalTrials.gov in a new tab)Other idTOL2581A
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
64 participants (actual)
Sponsor
Tolmar Inc. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
6 countries

United States, Argentina, Canada, Chile, Mexico, New Zealand

Start
31 Aug 2015
Primary completion
5 Sept 2018
Completion
5 Sept 2018
First posted
25 May 2015 (estimated)
Last update posted
2 Jun 2020
Conditions
Precocious Puberty, Central

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016201720182019
  1. Ph 3

    Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty

    NCT02452931

    31 Aug 2015 to 5 Sept 2018

Registry summary

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

This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.

Interventions

  • Leuprolide Acetate 45 mgDrug

Arms1

  • Experimental

    Assigned Intervention

    Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.

    Time frame · 6 months

    Registry description

    Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH \<4 IU/L. Peak stimulated LH refers to the maximum LH concentration measured 30 minutes after a gonadotropin-releasing hormone agonst (GnRHa) stimulation test.

Secondary outcomes(10)

  1. Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels.

    Time frame · Week 12, Week 24, Week 36, and Week 48

    Registry description

    Percentage of subjects with suppressed serum LH concentrations(\<4 IU/L) 30 minutes post GnRHa stimulation test at all assessed timepoints.

  2. Changes in Height Velocity (Growth Rate)

    Time frame · Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48

    Registry description

    Changes in height velocity (growth rate) at all study timepoints after Screening to end of study. Growth velocity is defined for each visit as change from baseline / \[(number of weeks since baseline)/52\]. Week 48: Change from Week 24 growth velocity is defined as change from week 24 to week 48 / \[(number of weeks since week 24)/52\].

  3. Bone Age Ratio to Chronological Age at Time of Measurement

    Time frame · Week 24 and Week 48

    Registry description

    Bone Age Ratio to Chronological Age at Time of Measurement is bone age/age at bone age assessment.

  4. Percent Change From Baseline in Height

    Time frame · Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48

    Registry description

    The percent change from baseline in height at each available post-baseline measurement. Percent change is defined as (((change from Baseline)/(Baseline)) x 100).

  5. Tanner Scores: Boys - Development of External Genitalia

    Time frame · Baseline, Week 12, Week 24, Week 36, and Week 48

    Registry description

    Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.

  6. Tanner Scores: Boys - Development of External Genitalia (Change From Baseline)

    Time frame · Week 12, Week 24, Week 36, and Week 48

    Registry description

    Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.

  7. Tanner Scores: Boys and Girls - Pubic Hair

    Time frame · Baseline, Week 12, Week 24, Week 36, and Week 48

    Registry description

    Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.

  8. Tanner Scores: Boys and Girls - Pubic Hair (Change From Baseline)

    Time frame · Week 12, Week 24, Week 36, and Week 48

    Registry description

    Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.

  9. Tanner Scores: Girls - Breast Development

    Time frame · Baseline, Week 12, Week 24, Week 36, and Week 48

    Registry description

    Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.

  10. Tanner Scores: Girls - Breast Development (Change From Baseline)

    Time frame · Week 12, Week 24, Week 36, and Week 48

    Registry description

    Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.

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 outcomeCount of participants· 6 months

Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.

GroupValue (Participants)
Assigned Intervention54
Secondary and other outcome results(7)
Secondary outcomeCount of participants· Week 12, Week 24, Week 36, and Week 48

Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels.

GroupValue (Participants)
Assigned Intervention51
Secondary outcomeMean· Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48

Changes in Height Velocity (Growth Rate)

GroupValue (cm/year)Spread
Assigned Intervention8.8913.128
Secondary outcomeMean· Week 24 and Week 48

Bone Age Ratio to Chronological Age at Time of Measurement

GroupValue (Ratio)Spread
Assigned Intervention1.390.160
Secondary outcomeMean· Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48

Percent Change From Baseline in Height

GroupValue (Percent change)Spread
Assigned Intervention0.50.78
Secondary outcomeMean· Baseline, Week 12, Week 24, Week 36, and Week 48

Tanner Scores: Boys - Development of External Genitalia

GroupValue (Score on a scale)Spread
Assigned Intervention3.00.00
Secondary outcomeMean· Week 12, Week 24, Week 36, and Week 48

Tanner Scores: Boys - Development of External Genitalia (Change From Baseline)

GroupValue (Score on a scale)Spread
Assigned Intervention-0.50.71
Secondary outcomeMean· Baseline, Week 12, Week 24, Week 36, and Week 48

Tanner Scores: Boys and Girls - Pubic Hair

GroupValue (Score on a scale)Spread
Assigned Intervention2.30.81

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Assigned InterventionLeuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period. Leuprolide Acetate 45 mg: Subcutaneous injection0 / 641 / 6455 / 64

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

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2020

Corrected

Phase 3 Trial of a Small-volume Subcutaneous 6-Month Duration Leuprolide Acetate Treatment for Central Precocious Puberty.

Klein et al. 2020The Journal of clinical endocrinology and metabolismcited by 32

PMID 32738042PMC7442270DOI 10.1210/clinem/dgaa479PUB-32738042

CC BY
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Eligibility

Who could join, as posted.

Sex
All
Age
from 2 Years up to 9 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Females age 2 to 8 years (inclusive) or males age 2 to 9 years (inclusive) * Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP * Pubertal-type LH response following an abbreviated GnRHa stimulation test before treatment initiation * Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males * Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year Exclusion Criteria: * Gonadotropin-independent (peripheral) precocious puberty * Prior or current GnRH treatment for CPP * Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1) * Diagnosis of short stature (ie, 2.25 standard deviations (SD) below the mean height for age) * Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions * Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study

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