Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty
- Registration Number
- NCT01467882
- Lead Sponsor
- Debiopharm International SA
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Triptorelin Triptorelin Triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
- Primary Outcome Measures
Name Time Method Percentage of Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6 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
Name Time Method Percentage of Children Maintaining LH Suppression at </= 4 IU/L 30 Minutes After Leuprolide Stimulation From Month 6 to 12 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.
Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12 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 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 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 Girls With Regression of Uterine Length Compared to Baseline at Months 6 and 12 Baseline to Months 6 and 12 Percentage of Boys With Absence of Progression of Testis Volumes Compared to Baseline at Months 6 and 12 Baseline to Months 6 and 12 Percentage of Children With Prepubertal Estradiol or Testosterone Levels at Months 1, 2, 3, 6, 9, and 12 at Months 1, 2, 3, 6, 9, and 12 Percentage of Children Without Higher Basal LH and Estradiol or Testosterone 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 Baseline to Months 6 and 12 Change From Baseline in Height-for-age Percentile Per 2000 CDC Growth Charts at Months 6 and 12 Baseline to Months 6 and 12 Change From Baseline in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) at Months 1, 2, 3, 6, 9, and 12 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 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 Baseline to Months 1, 2, 3, 6, 9, and 12 Change From Baseline in Growth Velocity at Months 6 and 12 Baseline to Months 6 and 12 Percentage of Participants Without Bone Age / Chronological Age Ratio Increase From Baseline at Months 6 and 12 Baseline to Months 6 and 12 Percentage of Children Achieving Stabilization of Sexual Maturation at Months 6 and 12 at Months 6 and 12
Trial Locations
- Locations (12)
Swedish Pediatric Specialist
🇺🇸Seattle, Washington, United States
IDIMI
🇨🇱Santiago, Chile
Hospital Universitario de Monterrey
🇲🇽Monterrey, Mexico
Pediatric Endocrinology of Phoenix
🇺🇸Phoenix, Arizona, United States
Arnold Palmer Pediatric Endocrinology Practice
🇺🇸Orlando, Florida, United States
Children's National Medical Center
🇺🇸Washington, D.C., District of Columbia, United States
Nancy Wright MD P.A.
🇺🇸Tallahassee, Florida, United States
Women's & Children's Hospital of Buffalo
🇺🇸Buffalo, New York, United States
Hackensack university medical center
🇺🇸Hackensack, New Jersey, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Lynn health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States