Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty

Condition(s) targeted: Precocious Puberty

Intervention: Triptorelin (I.N.N.) (Decapeptyl® SR 11.25mg) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Ipsen

Official(s) and/or principal investigator(s):
Brigitte Palestro, MD, Study Director, Affiliation: Ipsen

Overall contact:
Ipsen Recruitment Enquiries, Email: clinical.trials@ipsen.com

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.

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: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of children with a negative LH response to GnRH test: stimulated LH < 3 IU/l

Secondary outcome:

Follicle Stimulating Hormone (FSH) response to GnRH test

LH response to GnRH test

FSH and LH levels

Estradiol levels in girls (the pre-pubertal range: ≤ 20 pg/ml) and testosterone levels in boys (the pre-pubertal range: ≤ 0.3 ng/ml)

Inhibin B levels in girls (the pre-pubertal range ≤ 6 pg/ml)

Pubertal stage (Tanner method)

Height, weight and growth velocity

Bone age variation (Greulich and Pyle method)

The proportion of girls who achieve regression within pre-pubertal ranges of the uterine length

Triptorelin plasma levels

Spontaneous adverse events, vital signs, laboratory data and solicited local tolerance

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Patients MUST satisfy all of the following entry criteria before they will be allowed to participate in the study:

- 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.

- Aged 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.

Ipsen Recruitment Enquiries, Email: clinical.trials@ipsen.com

Hôpital Hotel-Dieu (CHU), Angers 49033, France; Recruiting

Hôpital Saint-Jacques, Besancon 25030, France; Recruiting

Medical Centre, Bordeaux 33000, France; Recruiting

Hôpital du Bocage, Dijon 21034, France; Recruiting

Hôpital Flaubert, Le Havre 76083, France; Recruiting

Hôpital Jeanne de Flandre, Lille 59037, France; Recruiting

Hôpital Debrousse, Lyon 69322, France; Recruiting

Hôpital de la Timone Enfants, Marseille 13385, France; Recruiting

Hôpital Archet 2, Nice 06202, France; Recruiting

Hôpital St-Vincent de Paul, Paris 75014, France; Recruiting

Hôpital Necker - Enfants Malades, Paris 75015, France; Recruiting

Hôpital Trousseau, Paris 75012, France; Recruiting

Hôpital Robert Debré, Paris 75019, France; Recruiting

American Memorial Hospital, Reims 51092, France; Recruiting

Hôpital Charles Nicolle, Rouen 76031, France; Recruiting

Hôpital Hautepierre, Strasbourg 67100, France; Recruiting

Hôpital de la Gespe, Tarbes 65013, France; Recruiting

Hôpital des Enfants, Toulouse 31026, France; Recruiting

Starting date: October 2007
Last updated: July 27, 2010