Clinical trial NCT00909844: Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Precocious Puberty
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2009-05-29
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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)
timeFrame: Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)
Secondary outcomes:
measure: Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test
timeFrame: Months -6, 0 and 36
measure: Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA)
timeFrame: Months -6, 0, 12, 36 and Final Visit (up to 63 months)
measure: Percentage of Patients With a Suppressed Follicle Stimulating Hormone (FSH) Response to GnRH Test
timeFrame: Months -6, 0 and 36
measure: Body Mass Index (BMI) for Chronological Age Variation
timeFrame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
measure: BMI Standard Deviation (SD) Score for Chronological Age Variation
timeFrame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
measure: Auxological Parameters Variations: Height SD Score
timeFrame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
measure: Auxological Parameters Variations: Growth Velocity SD Score
timeFrame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
measure: Auxological Parameters Variations: Weight Variation
timeFrame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
measure: Predicted Adult Height SD Score
timeFrame: Months -6, 0, 12 and Final Visit (up to 63 months)
measure: Bone Age Maturation
timeFrame: Months -6, 0 and Final Visit (up to 63 months)
measure: Percentage of Girls With a Uterine Length < 36 Millimetres (mm)
timeFrame: Months -6, 0, 12, 24, 36 and Final Visit (up to 63 months)
measure: 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)
timeFrame: Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)
Other outcomes:
Locations:
city: Angers
country: France
facility: Hôpital Hôtel Dieu (CHU)
city: Bordeaux
country: France
facility: Medical Centre
city: Le Havre
country: France
facility: Hôpital Flaubert
city: Nice
country: France
facility: Hôpital Archet II
city: Paris
country: France
facility: Hôpital Robert Debré
city: Reims
country: France
facility: American Memorial Hospital
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Strasbourg
country: France
facility: Hôpital Hautepierre
city: Tarbes
country: France
facility: Hôpital de la Gespe
city: Toulouse
country: France
facility: Hôpital des Enfants
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: