Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty
Information source: Ipsen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Precocious Puberty
Intervention: Triptorelin pamoate 11.25mg (Decapeptyl® SR) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Ipsen Official(s) and/or principal investigator(s): Joelle Blumberg, MD, Study Director, Affiliation: Ipsen
Summary
The purpose of the study is to assess the efficacy of triptorelin 11. 25 mg pamoate in the
delay of premature onset of puberty in girls less than 9 years and boys less than 10 years.
This is measured by assessing the proportion of children who have a suppressed Luteinizing
Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after
injection with triptorelin 11. 25 mg.
Clinical Details
Official title: Phase III, Multicentre, Non-comparative, Open and Single Stage Study to Assess the Efficacy and Safety of Pamoate of Triptorelin 11.25 MG in Children With Precocious Puberty
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L
Secondary outcome: Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/LFollicle Stimulating Hormone (FSH) Level Following GnRH Test Basal FSH Level Basal LH Level Number of Girls With Oestradiol Levels ≤ 20 pg/ml Testosterone Level Number of Girls With Inhibin B Levels < 6 pg/ml Change From Screening in Pubertal Stage (Tanner Method) at Month 6 Height Standard Deviation Score (SDS) Body Mass Index (BMI) SDS Change From Baseline in Growth Velocity (GV) SDS at Month 6 Difference Between Bone Age and Chronological Age Uterine Length Triptorelin Plasma Levels
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria in the screening phase:
- Onset of sex characteristics (Tanner method) breast development in girls or
testicular enlargement in boys before the age of 8 years in girls and 9 years in
boys.
- Weight ≥ 20 kg.
Inclusion Criteria in the treatment phase:
- Proven central precocious puberty defined as onset of sex characteristics development
(according to Tanner method) diagnosed before the age of 8 years in girls and 9 years
in boys.
- Age at evaluation less than 9 years for girls and 10 years for boys.
- A pubertal response of LH to GnRH test in both sexes (stimulated LH ≥ 5 IU/l).
- Difference Bone age (BA) (according to Greulich et Pyle method) - Chronological age
(CA) > 1 year.
- Testosterone level ≥ 0. 5 ng/ml in boys.
Exclusion Criteria:
- Patient with a peripheral precocious puberty: extrapituitary secretion of
gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion.
- Patient with a cerebral tumour requiring a neurosurgery or cerebral irradiation.
- Patient with a Body Weight ≥ 125% of the ideal weight for the height and age (growth
curves).
- The patient has received a previous treatment with a GnRH analogue, or
medroxyprogesterone or cyproterone acetate.
Locations and Contacts
Hôpital Hotel-Dieu (CHU), Angers 49033, France
Hôpital Saint-Jacques, Besancon 25030, France
Medical Centre, Bordeaux 33000, France
Hôpital du Bocage, Dijon 21034, France
Hôpital Flaubert, Le Havre 76083, France
Hôpital Jeanne de Flandre, Lille 59037, France
Hôpital Debrousse, Lyon 69322, France
Hôpital de la Timone Enfants, Marseille 13385, France
Hôpital Archet 2, Nice 06202, France
Hôpital Necker - Enfants Malades, Paris 75015, France
Hôpital Robert Debré, Paris 75019, France
Hôpital St-Vincent de Paul, Paris 75014, France
Hôpital Trousseau, Paris 75012, 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
Additional Information
Starting date: October 2007
Last updated: February 9, 2012
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