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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT01467882 (opens ClinicalTrials.gov in a new tab)Other idDebio 8206-CPP-301
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
44 participants (actual)
Sponsor
Debiopharm International SA · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
3 countries

United States, Chile, Mexico

Start
Apr 2012
Primary completion
Aug 2013
Completion
Jul 2014
First posted
9 Nov 2011 (estimated)
Last update posted
28 Jul 2017
Conditions
Central Precocious Puberty

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. Ph 3

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

    NCT01467882

    Apr 2012 to Jul 2014

Registry summary

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

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).

Interventions

  • TriptorelinDrug

Arms1

  • Experimental

    Triptorelin

    Triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Month 6

    Registry description

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

Secondary outcomes(16)

  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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

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· Month 6

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

GroupValue (percentage of participants)
Children93.18
Secondary and other outcome results(7)
Secondary outcomeNumber· at Months 1, 2, 3, 9 and 12

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

GroupValue (percentage of participants)
Children95.45
Secondary outcomeNumber· from Month 6 to 12

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

GroupValue (percentage of participants)
Children93.18
Secondary outcomeNumber· at Months 1, 2, 3, 6, 9 and 12

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

GroupValue (percentage of participants)
Children95.45
Secondary outcomeNumber· from Month 6 to 12

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

GroupValue (percentage of participants)
Children90.91
Secondary outcomeMean· Baseline to Months 1, 2, 3, 6, 9, and 12

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

GroupValue (IU/L)Spread
All Children Luteinizing Hormone-25.2120.28
All Children Follicle Stimulating Hormone-8.854.15
Secondary outcomeMean· Baseline to Months 1, 2, 3, 6, 9, and 12

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

GroupValue (ng/L)Spread
Girls-31.8727.82
Secondary outcomeMean· Baseline to Months 1, 2, 3, 6, 9, and 12

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

GroupValue (ng/dL)Spread
Boys-306.96184.06

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ChildrenAll children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169–1 / 4420 / 44

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

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2006

6 results

Treatment of central precocious puberty with triptorelin 11.25 mg depot formulation.

Martínez-Aguayo et al. 2006Journal of pediatric endocrinology & metabolism : JPEMcited by 19

PMID 16995580DOI 10.1515/jpem.2006.19.8.963PUB-16995580

Full text at the publisher6 results
Publisher pageSee results (6)

More studies

1 study on this page

Indexing hint: Review · 2000

Pharmacokinetics and pharmacodynamics of GnRH agonists: clinical implications in pediatrics.

Lahlou et al. 2000Journal of pediatric endocrinology & metabolism : JPEMcited by 61

PMID 10969915DOI 10.1515/jpem.2000.13.s1.723PUB-10969915

Full text at the publisher
Publisher page

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: 1. 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. 2. 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. 3. Initiation of triptorelin treatment at the latest 18 months after onset of the first signs of precocious puberty. 4. Difference (Δ) bone age (Greulich and Pyle method) - chronological age ≥ 1 year. 5. Pubertal-type LH response 30 minutes following a GnRH agonist stimulation test before treatment initiation (leuprolide acetate 20 μg/kg SC) ≥ 6 IU/L. 6. Clinical evidence of puberty, defined as Tanner Staging ≥ 2 for breast development for girls and testicular volume ≥ 4 mL (cc) for boys. 7. 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: 1. Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion. 2. Non-progressing isolated premature thelarche. 3. Presence of an unstable intracranial tumour or an intracranial tumour requiring neurosurgery or cerebral irradiation. Patients with hamartomas not requiring surgery are eligible. 4. Evidence of renal (creatinine \> 2 x ULN) or hepatic impairment (bilirubin or ASAT \> 3 x ULN). 5. 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). 6. Prior or current therapy with a GnRH agonist, medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF 1). 7. Major medical or psychiatric illness that could interfere with study visits. 8. Diagnosis of short stature, i.e. \> 2.25 SD below the mean height for age. 9. Positive pregnancy test. 10. Known hypersensibility to any of the test materials or related compounds. 11. Use of anticoagulants (heparin and coumarin derivatives).

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