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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/L

Follicle 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

Page last updated: August 23, 2015

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