Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study
DECAPUB
Follow-up of the Phase III, Multicentre, Non Comparative, One Single Group, Open Study to Assess the Long-term Efficacy and Tolerability of Pamoate of Triptorelin 11.25 mg in Children With Precocious Puberty
2 other identifiers
interventional
35
1 country
10
Brief Summary
The purpose of the protocol is to assess the efficacy of triptorelin 11.25 mg with respect to the proportion of children who maintain a regression or stabilisation of sexual maturity until the end of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2008
Longer than P75 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 28, 2009
CompletedFirst Posted
Study publicly available on registry
May 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
May 1, 2017
CompletedJanuary 15, 2019
January 1, 2019
7 years
May 28, 2009
December 28, 2016
January 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Children With a Stabilisation or Regression of Tanner Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0)
The primary objective was to assess efficacy of triptorelin pamoate 11.25 mg with respect to percentage of children maintaining a regression or stabilisation of sexual maturity (based on Tanner breast \[girls\] or genital \[boys\] pubertal stage) until end of study. Study treatment lasted until end of the therapeutic period; visits for Months 36 and 48 were optional since a child may have already finished the study at a prior visit. The Final Visit only occurred if the child did not end the study by a complete visit such as at Months 24, 36 or 48. Results are presented only for percentage of girls with regression or stabilisation of Tanner breast pubertal stage (n=34). Since only one boy was included in the study, results for this outcome measure were listed only and no statistical analysis was performed. Please also note additional post-hoc analysis for regression or stabilisation of Tanner breast pubertal stage which applied the variable Last Visit on Treatment instead of Final Visit.
Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)
Secondary Outcomes (12)
Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test
Months -6, 0 and 36
Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA)
Months -6, 0, 12, 36 and Final Visit (up to 63 months)
Percentage of Patients With a Suppressed Follicle Stimulating Hormone (FSH) Response to GnRH Test
Months -6, 0 and 36
Body Mass Index (BMI) for Chronological Age Variation
Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
BMI Standard Deviation (SD) Score for Chronological Age Variation
Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
- +7 more secondary outcomes
Study Arms (1)
Triptorelin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- The child must have completed study 2-54-52014-143
- The child must have an effective response to 2 injections of triptorelin 11.25 mg according to investigator's evaluation with no significant treatment side effects
You may not qualify if:
- The patient has a known hypersensitivity to any of the test materials or related compounds
- The patient is unable or unwilling to comply fully with the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (10)
Hôpital Hôtel Dieu (CHU)
Angers, 49033, France
Medical Centre
Bordeaux, 33000, France
Hôpital Flaubert
Le Havre, 76083, France
Hôpital Archet II
Nice, 06202, France
Hôpital Robert Debré
Paris, 75019, France
American Memorial Hospital
Reims, 51092, France
Hôpital Charles Nicolle
Rouen, 76031, France
Hôpital Hautepierre
Strasbourg, 67100, France
Hôpital de la Gespe
Tarbes, 65013, France
Hôpital des Enfants
Toulouse, 31026, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Since almost no hormonal data was collected after Baseline and only limited data was collected after Baseline for all other efficacy endpoints, only limited post-Baseline data is reported for the trial overall. All data analysed has been presented.
Results Point of Contact
- Title
- Medical Director, Endocrinology
- Organization
- Ipsen Pharma
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2009
First Posted
May 29, 2009
Study Start
April 1, 2008
Primary Completion
April 1, 2015
Study Completion
January 1, 2016
Last Updated
January 15, 2019
Results First Posted
May 1, 2017
Record last verified: 2019-01