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Completed

NCT Number: NCT02452931

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

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

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Key information

Conditions

Precocious Puberty, Central Endocrine System Diseases Gonadal Disorders Puberty, Precocious

Age range

2 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de Ninos, Buenos Aires, Argentina

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About this study

Leuprolide acetate is a GnRH agonist that inhibits pituitary gonadotropin secretion by binding to the GnRH receptors and blocking downstream hormone synthesis. The steady decrease in hormone synthesis (LH and FSH) leads to a suppression of testicular and ovarian steroidogenesis. In children with CPP, this steady decrease in hormone synthesis disrupts the progression of puberty.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leuprolide Acetate 45 mg

Drug

Subcutaneous injection

Primary outcomes

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

    Time frame: 6 months

    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

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

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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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.

Other outcomes

  1. Height

    Time frame: Screening, Baseline, Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48

    Height at each available measurement point. Baseline is defined as the last non-missing height measurement collected prior to or on the date of first injection.

  2. Bone Age

    Time frame: Baseline, Week 24, and Week 48

    Bone Age at each available measurement point.

  3. Bone Age Progression

    Time frame: Week 24 and Week 48

    Bone age progression at each available post-baseline measurement point. Bone age progression is defined as (((change from baseline)/(baseline)) x 100), which is percent change from baseline.

  4. Bone Age Ratio to Chronological Age at Time of Measurement (Percent Change From Baseline)

    Time frame: Week 24 and Week 48

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

  5. Bone Age Ratio to Chronological Age at Start of Study (Percent Change From Baseline)

    Time frame: Week 24 and Week 48

    Bone age advancement was evaluated relative to chronological age at each given measurement point. Percent change from baseline is: 100 x (the change from baseline value at the post-baseline visit / baseline value).

  6. Bone Age Ratio to Chronological Age at Start of Study

    Time frame: Baseline, Week 24, and Week 48

    Bone age advancement was evaluated relative to chronological age at each given measurement point. Bone Age Ratio to Chronological Age at Start of Study is bone age/age at first injection.

  7. GnRH Antagonist Evaluation

    Time frame: Week 2, Week 4, Week 12, Week 20, Week 24, Week 26, Week 36, Week 44, and Week 48

    GnRH Antagonist Evaluation occurred for the two week period following each treatment and at each visit to assess flare symptoms. The percent of subjects who affirm (or whose parent/guardian affirms) each symptom domain in the global interview.

  8. Percentage of Subjects With Suppression of FSH, Estradiol, Oestradiol (HS), and Testosterone Measured by Blood Levels.

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

    The percentage of subjects with FSH, estradiol and testosterone suppression to prepubertal levels (FSH < 2.5 mIU/mL, estradiol < 20 pg/mL and testosterone < 28.4 ng/dL) at each available time point.

  9. Changes in the Ratio of LH/FSH

    Time frame: Screening (Pre&Post GnRHa Stim Test), Baseline (0,1,4,6 hours Post-Injection), Week 4, Week 12 (Pre&Post GnRHa Stim Test), Week 20, Week 24 (Pre&Post GnRHa Stim Test), Week 36 (Pre&Post GnRHa Stim Test), Week 44, and Week 48 (Pre&Post GnRHa Stim Test)

    Changes in ratio of LH/FSH at each time point from Screening to End of Study

Sponsors and collaborators

Lead sponsor

Tolmar Inc.

Industry

Registry information

Official study title

An Open-label, Single Arm, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Leuprolide Acetate 45 mg for Injectable Suspension Controlled Release in Subjects With Central (Gonadotropin-Dependent) Precocious Puberty

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 25, 2015
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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