Phase 3
N=44
Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty
Central Precocious Puberty
Bottom Line
View on ClinicalTrials.gov: NCT01467882 ↗Enrolled (actual)
44
Serious AEs
2.3%
Results posted
Sep 2015
Primary outcome: Primary: Percentage of Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6 — 93.18 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Triptorelin (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Debiopharm International SA
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6 |
93.18 | — |
| SECONDARY Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12 |
95.45; 95.45; 95.45; 95.45; 97.73 | — |
| SECONDARY Percentage of Children Maintaining LH Suppression at Prepubertal Levels 30 Minutes After Leuprolide Stimulation From Month 6 to 12 |
93.18 | — |
| SECONDARY Percentage of Children With LH Suppression (LH ≤ 4 IU/L)30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 6, 9 and 12 |
95.45; 95.45; 93.18; 90.91; 93.18; 97.73 | — |
| SECONDARY Percentage of Children Maintaining LH Suppression at </= 4 IU/L 30 Minutes After Leuprolide Stimulation From Month 6 to 12 |
90.91 | — |
| SECONDARY Change From Baseline in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) at Months 1, 2, 3, 6, 9, and 12 |
-25.21; -8.85; -25.25; -8.80; -25.17; -8.13 | — |
| SECONDARY Change From Baseline in Estradiol Levels at Months 1, 2, 3, 6, 9, and 12 |
-31.87; -31.24; -32.15; -28.18; -30.08; -29.74 | — |
| SECONDARY Change From Baseline in Testosterone Levels at Months 1, 2, 3, 6, 9, and 12 |
-306.96; -290.70; -319.20; -317.62; -315.54; -301.86 | — |
| SECONDARY Percentage of Children With Prepubertal Estradiol or Testosterone Levels at Months 1, 2, 3, 6, 9, and 12 |
86.36; 87.18; 80.00; 88.37; 89.47; 80.00 | — |
| SECONDARY Percentage of Children Without Higher Basal LH and Estradiol or Testosterone |
13.64 | — |
| SECONDARY Change From Baseline in Height-for-age Z-score Per 2000 CDC Growth Charts at Months 6 and 12 |
0.05; 0.00 | — |
| SECONDARY Change From Baseline in Height-for-age Percentile Per 2000 CDC Growth Charts at Months 6 and 12 |
1.01; 0.91 | — |
| SECONDARY Change From Baseline in Growth Velocity at Months 6 and 12 |
6.84; 6.05 | — |
| SECONDARY Percentage of Participants Without Bone Age / Chronological Age Ratio Increase From Baseline at Months 6 and 12 |
63.64; 95.45 | — |
| SECONDARY Percentage of Children Achieving Stabilization of Sexual Maturation at Months 6 and 12 |
90.91; 88.64 | — |
| SECONDARY Percentage of Girls With Regression of Uterine Length Compared to Baseline at Months 6 and 12 |
69.23; 76.92 | — |
| SECONDARY Percentage of Boys With Absence of Progression of Testis Volumes Compared to Baseline at Months 6 and 12 |
100.00; 100.00 | — |
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).
Eligibility 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. 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).
Data sourced from ClinicalTrials.gov (NCT01467882). 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.