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Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty
This study has been completed.
Sponsor:
Debiopharm International SA
Information provided by (Responsible Party):
Debiopharm International SA
ClinicalTrials.gov Identifier:
NCT01467882
First received: November 7, 2011
Last updated: August 5, 2015
Last verified: August 2015
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
| Central Precocious Puberty | Drug: Triptorelin | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
central precocious puberty
familial male-limited precocious puberty
MedlinePlus related topics:
Puberty
Drug Information available for:
Triptorelin pamoate
U.S. FDA Resources
Further study details as provided by Debiopharm International SA:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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.
- 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.
- 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.
- 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.
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Percentage of Children Without Higher Basal LH and Estradiol or Testosterone [ Time Frame: at 2 days after second triptorelin injection (Day 171) ]
- 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 ]
- 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 ]
- Change From Baseline in Growth Velocity at Months 6 and 12 [ Time Frame: Baseline to Months 6 and 12 ]
- 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 ]
- Percentage of Children Achieving Stabilization of Sexual Maturation at Months 6 and 12 [ Time Frame: at Months 6 and 12 ]
- Percentage of Girls With Regression of Uterine Length Compared to Baseline at Months 6 and 12 [ Time Frame: Baseline to Months 6 and 12 ]
- 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 ]
| Enrollment: | 44 |
| Study Start Date: | April 2012 |
| Study Completion Date: | July 2014 |
| Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Triptorelin
Triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
|
Drug: Triptorelin
Powder and solution for solution for injection
Other Name: Trelstar
|
Eligibility| Ages Eligible for Study: | 2 Years to 9 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467882
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467882
Locations
| United States, Arizona | |
| Pediatric Endocrinology of Phoenix | |
| Phoenix, Arizona, United States, 85053 | |
| United States, California | |
| Children's National Medical Center | |
| San Diego, California, United States | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| Arnold Palmer Pediatric Endocrinology Practice | |
| Orlando, Florida, United States | |
| Nancy Wright MD P.A. | |
| Tallahasse, Florida, United States, 32308 | |
| United States, Missouri | |
| Washington University | |
| St. Louis, Missouri, United States | |
| United States, New Jersey | |
| Hackensack university medical center | |
| Hackensack, New Jersey, United States | |
| United States, New York | |
| Women's & Children's Hospital of Buffalo | |
| Buffalo, New York, United States | |
| United States, Ohio | |
| Cincinnati Children's Hospital | |
| Cincinnati, Ohio, United States | |
| United States, Oklahoma | |
| Lynn health Science Institute | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Washington | |
| Swedish Pediatric Specialist | |
| Seattle, Washington, United States | |
| Chile | |
| IDIMI | |
| Santiago, Chile | |
| Mexico | |
| Hospital Universitario de Monterrey | |
| Monterrey, Mexico | |
Sponsors and Collaborators
Debiopharm International SA
Investigators
| Principal Investigator: | Tala Dajani, MD | Pediatric Endocrinology of Phoenix, Arizona |
| Principal Investigator: | Barry Reiner, MD | Barry J. Reiner, MD, LLC, Baltimore, Maryland |
| Principal Investigator: | Galal Salem, MD | SRCR, Inc, Bell Gardens, California |
| Principal Investigator: | Heidi Shea, MD | Endocrine Associates of Dallas, Plano, Texas |
| Principal Investigator: | Mark Rappaport, MD | Pediatric Endocrine Associates, Atlanta, Georgia |
| Principal Investigator: | Opada Alzohaili, MD | Alzohaili Medical Consultants, Dearborn, Michigan |
| Principal Investigator: | Quentin Van Meter, MD | Van Meter Pediatric Endocrinology, Peachtree City, Georgia |
| Principal Investigator: | David Domek, MD | Lynn health Science Institute, Oklahoma City |
| Principal Investigator: | Kathleen Bethin, MD | Women's & Children's Hospital of Buffalo, New York |
| Principal Investigator: | Paul Kaplowitz, MD | Children's National Medical Center, Washington |
| Principal Investigator: | Karen Klein, MD | Children's National Medical Center, San Diego, California |
| Principal Investigator: | Diane Merritt, MD | Washington University, St. Louis, Missouri |
| Principal Investigator: | Susan Rose, MD | Cincinnati Children's Hospital, Ohio |
| Principal Investigator: | Gad Kletter, MD | Swedish Pediatric Specialist, Seattle, Washington |
| Principal Investigator: | Javier Aisenberg, MD | Hackensack university medical center, New Jersey |
| Principal Investigator: | Dennis Brenner, MD | St. Barnabas Medical Center, Livingston, New Jersey |
| Principal Investigator: | Douglas Rogers, MD | Cleveland Clinic, Ohio |
| Principal Investigator: | Lawrence Silverman, MD | Goryeb Children's Hospital, Morristown, New Jersey |
| Principal Investigator: | Peter Lee, MD | Penn State Hershey Children's Hospital, Pennsylvania |
| Principal Investigator: | Ricardo Gomez, MD | Children's Hospital, New Orleans, Louisiana |
| Principal Investigator: | Fernando Cassorla, MD | IDIMI, Santiago, Chile |
| Principal Investigator: | Joshua Yang, MD | Arnold Palmer Pediatric Endocrinology Practice, Orlando, Florida |
| Principal Investigator: | Erica Eugster, MD | James Whitcomb Riley Hospital for Children, Indianapolis, Indiana |
| Principal Investigator: | Oscar Flores, MD | Hospital Universitario de Monterrey, Mexico |
| Principal Investigator: | Nancy Wright, MD | Nancy Wright MD P.A., Tallahasse, Florida |
More Information
Additional Information:
Publications:
| Responsible Party: | Debiopharm International SA |
| ClinicalTrials.gov Identifier: | NCT01467882 History of Changes |
| Other Study ID Numbers: |
Debio 8206-CPP-301 |
| Study First Received: | November 7, 2011 |
| Results First Received: | June 25, 2015 |
| Last Updated: | August 5, 2015 |
Additional relevant MeSH terms:
|
Puberty, Precocious Gonadal Disorders Endocrine System Diseases Triptorelin Pamoate Luteolytic Agents Contraceptive Agents, Female |
Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 26, 2017