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CompletedNCT01467882Updated Jul 28, 2017Results posted

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

A Phase 3 interventional study of Triptorelin in Central Precocious Puberty, sponsored by Debiopharm International SA. Completed at 13 sites in 3 countries. Open to participants aged 2 Years to 9 Years. Per ClinicalTrials.gov, last updated 2017-07-28.

Sponsored by Debiopharm International SA · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
2 Years to 9 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Central Precocious Puberty

Browse trials for

03

In context

Puberty, Precocious

75 studies on the registry are indexed under Puberty, Precocious; 18 are open to participants now.

This study's enrollment of 44 is below the median of 64 across 47 interventional studies indexed under Puberty, Precocious.

Browse Puberty, Precocious studies →

Lead sponsor

Debiopharm International SA is the lead sponsor of 50 studies on the registry; 6 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Triptorelin

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

    Drug: Triptorelin

Interventions

  • DrugTriptorelin

    Powder and solution for solution for injection

    Also known as: Trelstar

06

What researchers measure

Primary outcomes

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

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

    Time frame: 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

    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.

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

  2. Percentage of Children Maintaining LH Suppression at Prepubertal Levels 30 Minutes After Leuprolide Stimulation 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.

    Time frame: from Month 6 to 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

    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.

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

  4. Percentage of Children Maintaining LH Suppression at </= 4 IU/L 30 Minutes After Leuprolide Stimulation 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.

    Time frame: from Month 6 to 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

07

Results

Posted Sep 4, 2015

Participant flow

Intention to treat, defined as all participants enrolled

Participant flow — Overall Study
MilestoneChildren
Started44
Completed44
Not completed0

Outcome measures

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

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

Time frame:
Month 6
Reported as:
Number · percentage of participants
Percentage of Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6
percentage of participantsChildren
Percentage of Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 693.18 (81.34 to 98.57)
SecondaryPercentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation 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.

Time frame:
at Months 1, 2, 3, 9 and 12
Reported as:
Number · percentage of participants
Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12
percentage of participantsChildren
Month 195.45
Month 295.45
Month 395.45
Month 995.45
Month 1297.73
SecondaryPercentage of Children Maintaining LH Suppression at Prepubertal Levels 30 Minutes After Leuprolide Stimulation 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.

Time frame:
from Month 6 to 12
Reported as:
Number · percentage of participants
Percentage of Children Maintaining LH Suppression at Prepubertal Levels 30 Minutes After Leuprolide Stimulation From Month 6 to 12
percentage of participantsChildren
Percentage of Children Maintaining LH Suppression at Prepubertal Levels 30 Minutes After Leuprolide Stimulation From Month 6 to 1293.18
SecondaryPercentage of Children With LH Suppression (LH ≤ 4 IU/L)30 Minutes After Leuprolide Stimulation 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.

Time frame:
at Months 1, 2, 3, 6, 9 and 12
Reported as:
Number · percentage of participants
Percentage of Children With LH Suppression (LH ≤ 4 IU/L)30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 6, 9 and 12
percentage of participantsChildren
Month 195.45
Month 295.45
Month 393.18
Month 690.91
Month 993.18
Month 1297.73
SecondaryPercentage of Children Maintaining LH Suppression at </= 4 IU/L 30 Minutes After Leuprolide Stimulation 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.

Time frame:
from Month 6 to 12
Reported as:
Number · percentage of participants
Percentage of Children Maintaining LH Suppression at </= 4 IU/L 30 Minutes After Leuprolide Stimulation From Month 6 to 12
percentage of participantsChildren
Percentage of Children Maintaining LH Suppression at </= 4 IU/L 30 Minutes After Leuprolide Stimulation From Month 6 to 1290.91
SecondaryChange 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
Reported as:
Mean · IU/L
Change From Baseline in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) at Months 1, 2, 3, 6, 9, and 12
IU/LAll Children Luteinizing HormoneAll Children Follicle Stimulating Hormone
at Month 1-25.21 ± 20.28-8.85 ± 4.15
at Month 2-25.25 ± 20.41-8.80 ± 4.20
at Month 3-25.17 ± 20.53-8.13 ± 4.26
at Month 6-23.06 ± 22.17-6.66 ± 4.61
at Month 9-25.24 ± 20.49-7.87 ± 4.27
at Month 12-25.15 ± 20.50-6.99 ± 4.63
SecondaryChange 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
Reported as:
Mean · ng/L
Change From Baseline in Estradiol Levels at Months 1, 2, 3, 6, 9, and 12
ng/LGirls
at Month 1-31.87 ± 27.82
at Month 2-31.24 ± 31.80
at Month 3-32.15 ± 28.65
at Month 6-28.18 ± 31.26
at Month 9-30.08 ± 27.44
at Month 12-29.74 ± 28.24
SecondaryChange 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
Reported as:
Mean · ng/dL
Change From Baseline in Testosterone Levels at Months 1, 2, 3, 6, 9, and 12
ng/dLBoys
at Month 1-306.96 ± 184.06
at Month 2-290.70 ± 214.81
at Month 3-319.20 ± 177.04
at Month 6-317.62 ± 178.11
at Month 9-315.54 ± 183.98
at Month 12-301.86 ± 205.29
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Children With Prepubertal Estradiol or Testosterone Levels at Months 1, 2, 3, 6, 9, and 12
percentage of participantsChildrenGirlsBoys
at Month 186.3687.1880.00
at Month 288.3789.4780.00
at Month 393.1892.31100.00
at Month 681.8279.49100.00
at Month 981.8282.0580.00
at Month 1279.5579.4980.00
SecondaryPercentage of Children Without Higher Basal LH and Estradiol or Testosterone
Time frame:
at 2 days after second triptorelin injection (Day 171)
Reported as:
Number · percentage of participants
Percentage of Children Without Higher Basal LH and Estradiol or Testosterone
percentage of participantsAOC Subset
Percentage of Children Without Higher Basal LH and Estradiol or Testosterone13.64
SecondaryChange 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
Reported as:
Mean · Z-score
Change From Baseline in Height-for-age Z-score Per 2000 CDC Growth Charts at Months 6 and 12
Z-scoreChildren
at Month 60.05 ± 0.20
at Month 120.00 ± 0.27
SecondaryChange 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
Reported as:
Mean · percentile
Change From Baseline in Height-for-age Percentile Per 2000 CDC Growth Charts at Months 6 and 12
percentileChildren
at Month 61.01 ± 3.21
at Month 120.91 ± 4.39
SecondaryChange From Baseline in Growth Velocity at Months 6 and 12
Time frame:
Baseline to Months 6 and 12
Reported as:
Mean · cm/year
Change From Baseline in Growth Velocity at Months 6 and 12
cm/yearChildren
at Month 66.84 ± 2.33
at Month 126.05 ± 1.7
SecondaryPercentage of Participants Without Bone Age / Chronological Age Ratio Increase From Baseline at Months 6 and 12
Time frame:
Baseline to Months 6 and 12
Reported as:
Number · percentage of participants
Percentage of Participants Without Bone Age / Chronological Age Ratio Increase From Baseline at Months 6 and 12
percentage of participantsChildren
at Month 663.64
at Month 1295.45
SecondaryPercentage of Children Achieving Stabilization of Sexual Maturation at Months 6 and 12
Time frame:
at Months 6 and 12
Reported as:
Number · percentage of participants
Percentage of Children Achieving Stabilization of Sexual Maturation at Months 6 and 12
percentage of participantsChildren
at Month 690.91
at Month 1288.64
SecondaryPercentage of Girls With Regression of Uterine Length Compared to Baseline at Months 6 and 12
Time frame:
Baseline to Months 6 and 12
Reported as:
Number · percentage of participants
Percentage of Girls With Regression of Uterine Length Compared to Baseline at Months 6 and 12
percentage of participantsGirls
at Month 669.23
at Month 1276.92
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Boys With Absence of Progression of Testis Volumes Compared to Baseline at Months 6 and 12
percentage of participantsBoys
at Month 6100.00
at Month 12100.00

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Children—1/44 (2.3%)20/44 (45.5%)
Most frequent serious events
Most frequent serious events
EventChildren
Device related infectionInfections and infestations1/44
Most frequent other events
Most frequent other events
EventChildren
HeadacheNervous system disorders6/44
NasopharyngitisInfections and infestations6/44
Upper respiratory tract infectionInfections and infestations4/44
CoughRespiratory, thoracic and mediastinal disorders3/44
GastroenteritisInfections and infestations3/44

Baseline characteristics

Intention to treat, defined as all participants enrolled

Age, Categorical
Age, Categorical(Participants)Children
<=18 years44
Between 18 and 65 years0
>=65 years0
Age, Continuous
Age, Continuous(years)Children
Mean7.41 ± 1.28
Sex: Female, Male
Sex: Female, Male(Participants)Children
Female39
Male5
Region of Enrollment
Region of Enrollment(participants)Children
United States28
Mexico1
Chile15
08

Study locations

13 sites
  • Pediatric Endocrinology of Phoenix
    Phoenix, Arizona 85053, United States
  • Children's National Medical Center
    San Diego, California, United States
  • Children's National Medical Center
    Washington, D.C., District of Columbia, United States
  • Arnold Palmer Pediatric Endocrinology Practice
    Orlando, Florida, United States
  • Nancy Wright MD P.A.
    Tallahassee, Florida 32308, United States
  • Washington University
    Saint Louis, Missouri, United States
  • Hackensack university medical center
    Hackensack, New Jersey, United States
  • Women's & Children's Hospital of Buffalo
    Buffalo, New York, United States
  • Cincinnati Children's Hospital
    Cincinnati, Ohio, United States
  • Lynn health Science Institute
    Oklahoma City, Oklahoma 73112, United States
  • Swedish Pediatric Specialist
    Seattle, Washington, United States
  • IDIMI
    Santiago, Chile
  • Hospital Universitario de Monterrey
    Monterrey, Mexico
09

References and documents

Publications

  • Carel JC, Eugster EA, Rogol A, Ghizzoni L, Palmert MR; ESPE-LWPES GnRH Analogs Consensus Conference Group; Antoniazzi F, Berenbaum S, Bourguignon JP, Chrousos GP, Coste J, Deal S, de Vries L, Foster C, Heger S, Holland J, Jahnukainen K, Juul A, Kaplowitz P, Lahlou N, Lee MM, Lee P, Merke DP, Neely EK, Oostdijk W, Phillip M, Rosenfield RL, Shulman D, Styne D, Tauber M, Wit JM. Consensus statement on the use of gonadotropin-releasing hormone analogs in children. Pediatrics. 2009 Apr;123(4):e752-62. doi: 10.1542/peds.2008-1783. Epub 2009 Mar 30. PubMed 19332438 ↗
  • Martinez-Aguayo A, Hernandez MI, Beas F, Iniguez G, Avila A, Sovino H, Bravo E, Cassorla F. Treatment of central precocious puberty with triptorelin 11.25 mg depot formulation. J Pediatr Endocrinol Metab. 2006 Aug;19(8):963-70. doi: 10.1515/jpem.2006.19.8.963. PubMed 16995580 ↗
  • Houk CP, Kunselman AR, Lee PA. The diagnostic value of a brief GnRH analogue stimulation test in girls with central precocious puberty: a single 30-minute post-stimulation LH sample is adequate. J Pediatr Endocrinol Metab. 2008 Dec;21(12):1113-8. doi: 10.1515/jpem.2008.21.12.1113. PubMed 19189683 ↗
  • Lahlou N, Carel JC, Chaussain JL, Roger M. Pharmacokinetics and pharmacodynamics of GnRH agonists: clinical implications in pediatrics. J Pediatr Endocrinol Metab. 2000 Jul;13 Suppl 1:723-37. doi: 10.1515/jpem.2000.13.s1.723. PubMed 10969915 ↗

Related links

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01467882
Lead sponsor
Debiopharm International SA
Responsible party
Sponsor
First posted
Nov 9, 2011
Start date
Apr 2012
Primary completion
Aug 2013
Completion
Jul 2014
Results posted
Sep 4, 2015
Last update
Jul 28, 2017

Study contacts

Tala Dajani, MD
principal investigator · Pediatric Endocrinology of Phoenix, Arizona
Barry Reiner, MD
principal investigator · Barry J. Reiner, MD, LLC, Baltimore, Maryland
Galal Salem, MD
principal investigator · SRCR, Inc, Bell Gardens, California
Heidi Shea, MD
principal investigator · Endocrine Associates of Dallas, Plano, Texas
Mark Rappaport, MD
principal investigator · Pediatric Endocrine Associates, Atlanta, Georgia
Opada Alzohaili, MD
principal investigator · Alzohaili Medical Consultants, Dearborn, Michigan
Quentin Van Meter, MD
principal investigator · Van Meter Pediatric Endocrinology, Peachtree City, Georgia
David Domek, MD
principal investigator · Lynn health Science Institute, Oklahoma City
Kathleen Bethin, MD
principal investigator · Women's & Children's Hospital of Buffalo, New York
Paul Kaplowitz, MD
principal investigator · Children's National Medical Center, Washington
Karen Klein, MD
principal investigator · Children's National Medical Center, San Diego, California
Diane Merritt, MD
principal investigator · Washington University, St. Louis, Missouri
Susan Rose, MD
principal investigator · Cincinnati Children's Hospital, Ohio
Gad Kletter, MD
principal investigator · Swedish Pediatric Specialist, Seattle, Washington
Javier Aisenberg, MD
principal investigator · Hackensack university medical center, New Jersey
Dennis Brenner, MD
principal investigator · St. Barnabas Medical Center, Livingston, New Jersey
Douglas Rogers, MD
principal investigator · Cleveland Clinic, Ohio
Lawrence Silverman, MD
principal investigator · Goryeb Children's Hospital, Morristown, New Jersey
Peter Lee, MD
principal investigator · Penn State Hershey Children's Hospital, Pennsylvania
Ricardo Gomez, MD
principal investigator · Children's Hospital, New Orleans, Louisiana
Fernando Cassorla, MD
principal investigator · IDIMI, Santiago, Chile
Joshua Yang, MD
principal investigator · Arnold Palmer Pediatric Endocrinology Practice, Orlando, Florida
Erica Eugster, MD
principal investigator · James Whitcomb Riley Hospital for Children, Indianapolis, Indiana
Oscar Flores, MD
principal investigator · Hospital Universitario de Monterrey, Mexico
Nancy Wright, MD
principal investigator · Nancy Wright MD P.A., Tallahasse, Florida

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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