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Central Precocious PubertyPhase 3NCT01467882

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

A Phase 3 study testing Triptorelin in people with Central Precocious Puberty, run by Debiopharm International SA at 13 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 2 to 9 years
Conditions the study is for
Central Precocious Puberty
What is being tested?
Triptorelin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
13 sitesin 3 countries
Study dates
Apr 2012to Jul 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
Show all 19Show fewer
  • 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).

Who cannot join

None listed.

Trial locations and contacts

13 sites in 3 countries.

13 sites in 3 countries

United States11 sites

  • Women's & Children's Hospital of Buffalo

    Buffalo, New York

  • Cincinnati Children's Hospital

    Cincinnati, Ohio

  • Hackensack university medical center

    Hackensack, New Jersey

  • Lynn health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Arnold Palmer Pediatric Endocrinology Practice

    Orlando, Florida

  • Pediatric Endocrinology of Phoenix

    Phoenix, Arizona, 85053

  • Children's National Medical Center

    San Diego, California

  • Swedish Pediatric Specialist

    Seattle, Washington

  • Washington University

    St Louis, Missouri

  • Nancy Wright MD P.A.

    Tallahassee, Florida, 32308

  • Children's National Medical Center

    Washington D.C., District of Columbia

Other trials in United States

Chile1 site

  • IDIMI

    Santiago

Other trials in Chile

Mexico1 site

  • Hospital Universitario de Monterrey

    Monterrey

Other trials in Mexico

About this study

Official 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

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).

Being tested
Triptorelin
Medical subject headings
Puberty, Precocious

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TriptorelinDrug

    Also called Trelstar

    Powder and solution for solution for injection

Study groups in NCT01467882
Study groupRoleWhat they receive
TriptorelinExperimentalTriptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
Receives: Drug: Triptorelin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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

    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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: at Months 1, 2, 3, 6, 9, and 12

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

    Measured: 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

    Measured: 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

    Measured: Baseline to Months 6 and 12

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

    Measured: Baseline to Months 6 and 12

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

    Measured: Baseline to Months 6 and 12

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

    Measured: at Months 6 and 12

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

    Measured: 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

    Measured: Baseline to Months 6 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2011 (estimated)
  2. Study startApr 2012
  3. Primary completionAug 2013
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01467882
Sponsor's protocol ID
Debio 8206-CPP-301
Status last verified
Jul 2017
First submitted
7 Nov 2011
Last updated
28 Jul 2017
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Triptorelin in people with Central Precocious Puberty, run by Debiopharm International SA at 13 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Chile, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6 (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01467882, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.

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