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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01467882 |
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Date of registration:
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07/11/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty
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Scientific title:
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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 |
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Date of first enrolment:
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April 2012 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01467882 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Chile
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Mexico
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United States
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Contacts
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Name:
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Ricardo Gomez, MD |
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Address:
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Affiliation:
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Children's Hospital, New Orleans, Louisiana |
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Name:
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Susan Rose, MD |
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Affiliation:
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Cincinnati Children's Hospital, Ohio |
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Name:
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Erica Eugster, MD |
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Affiliation:
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James Whitcomb Riley Hospital for Children, Indianapolis, Indiana |
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Name:
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David Domek, MD |
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Address:
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Affiliation:
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Lynn health Science Institute, Oklahoma City |
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Name:
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Gad Kletter, MD |
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Affiliation:
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Swedish Pediatric Specialist, Seattle, Washington |
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Name:
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Javier Aisenberg, MD |
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Affiliation:
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Hackensack university medical center, New Jersey |
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Name:
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Diane Merritt, MD |
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Address:
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Affiliation:
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Washington University, St. Louis, Missouri |
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Name:
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Karen Klein, MD |
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Address:
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Affiliation:
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Children's National Medical Center, San Diego, California |
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Name:
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Heidi Shea, MD |
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Affiliation:
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Endocrine Associates of Dallas, Plano, Texas |
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Name:
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Mark Rappaport, MD |
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Address:
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Affiliation:
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Pediatric Endocrine Associates, Atlanta, Georgia |
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Name:
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Opada Alzohaili, MD |
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Address:
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Affiliation:
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Alzohaili Medical Consultants, Dearborn, Michigan |
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Name:
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Oscar Flores, MD |
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Address:
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Affiliation:
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Hospital Universitario de Monterrey, Mexico |
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Name:
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Douglas Rogers, MD |
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Affiliation:
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Cleveland Clinic, Ohio |
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Name:
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Galal Salem, MD |
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Affiliation:
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SRCR, Inc, Bell Gardens, California |
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Name:
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Dennis Brenner, MD |
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Affiliation:
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St. Barnabas Medical Center, Livingston, New Jersey |
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Name:
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Paul Kaplowitz, MD |
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Address:
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Affiliation:
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Children's National Medical Center, Washington |
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Name:
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Peter Lee, MD |
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Address:
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Affiliation:
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Penn State Hershey Children's Hospital, Pennsylvania |
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Name:
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Barry Reiner, MD |
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Affiliation:
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Barry J. Reiner, MD, LLC, Baltimore, Maryland |
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Name:
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Lawrence Silverman, MD |
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Affiliation:
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Goryeb Children's Hospital, Morristown, New Jersey |
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Name:
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Fernando Cassorla, MD |
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Address:
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Affiliation:
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IDIMI, Santiago, Chile |
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Name:
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Tala Dajani, MD |
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Address:
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Affiliation:
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Pediatric Endocrinology of Phoenix, Arizona |
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Name:
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Quentin Van Meter, MD |
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Affiliation:
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Van Meter Pediatric Endocrinology, Peachtree City, Georgia |
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Name:
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Joshua Yang, MD |
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Address:
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Affiliation:
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Arnold Palmer Pediatric Endocrinology Practice, Orlando, Florida |
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Name:
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Nancy Wright, MD |
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Address:
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Affiliation:
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Nancy Wright MD P.A., Tallahasse, Florida |
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Name:
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Kathleen Bethin, MD |
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Address:
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Affiliation:
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Women's & Children's Hospital of Buffalo, New York |
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Key inclusion & exclusion criteria
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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 (?) 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).
Age minimum:
2 Years
Age maximum:
9 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Central Precocious Puberty
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Intervention(s)
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Drug: Triptorelin
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Primary Outcome(s)
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Percentage of Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6
[Time Frame: Month 6]
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Secondary Outcome(s)
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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]
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Percentage of Girls With Regression of Uterine Length Compared to Baseline at Months 6 and 12
[Time Frame: Baseline to Months 6 and 12]
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Change From Baseline in Growth Velocity at Months 6 and 12
[Time Frame: Baseline to Months 6 and 12]
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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]
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Percentage of Children Maintaining LH Suppression at
[Time Frame: from Month 6 to 12]
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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]
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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]
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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]
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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]
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Percentage of Children Achieving Stabilization of Sexual Maturation at Months 6 and 12
[Time Frame: at Months 6 and 12]
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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]
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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]
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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]
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Percentage of Children Without Higher Basal LH and Estradiol or Testosterone
[Time Frame: at 2 days after second triptorelin injection (Day 171)]
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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]
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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]
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Secondary ID(s)
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Debio 8206-CPP-301
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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