Clinical Trial: Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 (Gonado
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 Summary:
Sponsor: Debiopharm International SA
Current Primary Outcome: Percentage of Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6 [ Time Frame: Month 6 ]
Original Primary Outcome: Percentage of children with LH suppression to prepubertal levels 30 minutes after GnRH agonist stimulation at Month 6 (Day 169). [ Time Frame: Month 6 ]
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
Information By: Debiopharm International SA
Dates:
Date Received: November 7, 2011
Date Started: April 2012
Date Completion:
Last Updated: August 5, 2015
Last Verified: August 2015