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Completed

NCT Number: NCT01467882

Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty

The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg 6-month formulation in 44 patients suffering from central precocious puberty. The total study duration per patient will be 12 months (48 weeks).

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Key information

Conditions

Central Precocious Puberty 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

IDIMI, Santiago, Chile

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Onset of development of sex characteristics before 8 and 9 years in girls and boys, respectively (breast development in girls or testicular enlargement in boys according to the Tanner method), and candidate to receive at least 12 months of GnRH agonist therapy after study entry.
  • Aged 2-8 years inclusive (i.e. < 9 years) for girls and 2-9 years inclusive (i.e. < 10 years) for boys at initiation of triptorelin treatment.
  • Initiation of triptorelin treatment at the latest 18 months after onset of the first signs of precocious puberty.
  • Difference (Δ) bone age (Greulich and Pyle method) - chronological age ≥ 1 year.
  • Pubertal-type LH response 30 minutes following a GnRH agonist stimulation test before treatment initiation (leuprolide acetate 20 μg/kg SC) ≥ 6 IU/L.
  • Clinical evidence of puberty, defined as Tanner Staging ≥ 2 for breast development for girls and testicular volume ≥ 4 mL (cc) for boys.
  • Informed consent signed by one parent or both parents (as per local requirements), by the liable parent or by the legal guardian (when applicable); assent signed by the child if ≥ 7 years.

Non-inclusion criteria:

  • Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion.
  • Non-progressing isolated premature thelarche.
  • Presence of an unstable intracranial tumour or an intracranial tumour requiring neurosurgery or cerebral irradiation. Patients with hamartomas not requiring surgery are eligible.
  • Evidence of renal (creatinine > 2 x ULN) or hepatic impairment (bilirubin or ASAT > 3 x ULN).
  • Any other condition or chronic illness or treatment possibly interfering with growth or other study endpoints (e.g. chronic steroid use [except mild topical steroids], renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumour).
  • Prior or current therapy with a GnRH agonist, medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF 1).
  • Major medical or psychiatric illness that could interfere with study visits.
  • Diagnosis of short stature, i.e. > 2.25 SD below the mean height for age.
  • Positive pregnancy test.
  • Known hypersensibility to any of the test materials or related compounds.
  • Use of anticoagulants (heparin and coumarin derivatives).

Treatment and study plan

Triptorelin

Drug

Powder and solution for solution for injection

Other names: Trelstar

Primary outcomes

  1. Percentage of Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6

    Time frame: Month 6

    This is a lab test to see what percentage of participants were returned to normal before-puberty levels at Month 6.

Secondary outcomes

  1. Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12

    Time frame: at Months 1, 2, 3, 9 and 12

    This is a lab test to see what percentage of children were returned to normal before-puberty levels by the drug at each time point.

  2. Percentage of Children Maintaining LH Suppression at Prepubertal Levels 30 Minutes After Leuprolide Stimulation From Month 6 to 12

    Time frame: from Month 6 to 12

    This is a lab test to see what percentage of children stayed at the normal before-puberty level from month 6 to month 12.

  3. Percentage of Children With LH Suppression (LH ≤ 4 IU/L)30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 6, 9 and 12

    Time frame: at Months 1, 2, 3, 6, 9 and 12

    This is a lab test to see what percentage of children were returned to lower than normal before-puberty levels by the drug at each time point.

  4. Percentage of Children Maintaining LH Suppression at </= 4 IU/L 30 Minutes After Leuprolide Stimulation From Month 6 to 12

    Time frame: from Month 6 to 12

    This is a lab test to see what percentage of children stayed at the lower than normal before-puberty level from month 6 to month 12.

  5. Change From Baseline in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) at Months 1, 2, 3, 6, 9, and 12

    Time frame: Baseline to Months 1, 2, 3, 6, 9, and 12

  6. Change From Baseline in Estradiol Levels at Months 1, 2, 3, 6, 9, and 12

    Time frame: Baseline to Months 1, 2, 3, 6, 9, and 12

  7. Change From Baseline in Testosterone Levels at Months 1, 2, 3, 6, 9, and 12

    Time frame: Baseline to Months 1, 2, 3, 6, 9, and 12

  8. Percentage of Children With Prepubertal Estradiol or Testosterone Levels at Months 1, 2, 3, 6, 9, and 12

    Time frame: at Months 1, 2, 3, 6, 9, and 12

  9. Percentage of Children Without Higher Basal LH and Estradiol or Testosterone

    Time frame: at 2 days after second triptorelin injection (Day 171)

  10. Change From Baseline in Height-for-age Z-score Per 2000 CDC Growth Charts at Months 6 and 12

    Time frame: Baseline to Months 6 and 12

  11. Change From Baseline in Height-for-age Percentile Per 2000 CDC Growth Charts at Months 6 and 12

    Time frame: Baseline to Months 6 and 12

  12. Change From Baseline in Growth Velocity at Months 6 and 12

    Time frame: Baseline to Months 6 and 12

  13. Percentage of Participants Without Bone Age / Chronological Age Ratio Increase From Baseline at Months 6 and 12

    Time frame: Baseline to Months 6 and 12

  14. Percentage of Children Achieving Stabilization of Sexual Maturation at Months 6 and 12

    Time frame: at Months 6 and 12

  15. Percentage of Girls With Regression of Uterine Length Compared to Baseline at Months 6 and 12

    Time frame: Baseline to Months 6 and 12

  16. Percentage of Boys With Absence of Progression of Testis Volumes Compared to Baseline at Months 6 and 12

    Time frame: Baseline to Months 6 and 12

Sponsors and collaborators

Lead sponsor

Debiopharm International SA

Industry

Registry information

Official study title

An Open-label, Non-comparative, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Triptorelin Pamoate (Embonate) 22.5 mg 6-month Formulation in Patients Suffering From Central (Gonadotropin-dependent) Precocious Puberty

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Nov 9, 2011
Registry last updated
Jul 28, 2017

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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