Phase 3
N=35
Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study
Precocious Puberty
Bottom Line
View on ClinicalTrials.gov: NCT00909844 ↗Enrolled (actual)
35
Serious AEs
8.6%
Results posted
May 2017
Primary outcome: Primary: 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) — 61.8; 52.9 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Triptorelin (I.N.N.) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
61.8; 52.9 | — |
| SECONDARY Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test |
0; 91.4; 100 | — |
| SECONDARY Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA) |
18.59; 8.71; 2.50; 12.20; 10.00; 6.80 | — |
| SECONDARY Percentage of Patients With a Suppressed Follicle Stimulating Hormone (FSH) Response to GnRH Test |
0; 82.9; 0 | — |
| SECONDARY Body Mass Index (BMI) for Chronological Age Variation |
0.43; 1.60; 1.69; 1.69; 1.06; 2.39 | — |
| SECONDARY BMI Standard Deviation (SD) Score for Chronological Age Variation |
0.06; 0.16; -0.01; -0.04; -0.27; 0.10 | — |
| SECONDARY Auxological Parameters Variations: Height SD Score |
0.09; -0.05; -0.24; -0.83; -1.68; -0.36 | — |
| SECONDARY Auxological Parameters Variations: Growth Velocity SD Score |
-1.85; -2.44; -3.18; -6.97; -6.96; -2.70 | — |
| SECONDARY Auxological Parameters Variations: Weight Variation |
2.49; 7.56; 10.13; 12.70; 12.20; 13.17 | — |
| SECONDARY Predicted Adult Height SD Score |
0.31; 0.82; 2.13; 1.83 | — |
| SECONDARY Bone Age Maturation |
-0.16; -1.61; -1.69 | — |
| SECONDARY Percentage of Girls With a Uterine Length < 36 Millimetres (mm) |
42.4; 41.2; 16.7; 50.0; 0; 25.0 | — |
| SECONDARY Percentage of Children With a Stabilisation or Regression of Tanner Pubic Hair Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0) |
31.4; 37.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00909844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.