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

Precocious Puberty Clinical Trial

— DECAPUB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564850
• Other study ID #: 2-54-52014-143
• Secondary ID: 2005-005644-11
• Status: Completed
• Phase: Phase 3
• Start date: October 2007
• Est. completion date: October 2010

Study information

• Verified date: September 2022
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Precocious Puberty
• Puberty, Precocious

Intervention

Drug:
• Triptorelin pamoate 11.25mg (Decapeptyl® SR)
One intra muscular injection at day 1 and month 3.

Locations

Country	Name	City	State
France	Hôpital Hotel-Dieu (CHU)	Angers
France	Hôpital Saint-Jacques	Besancon
France	Medical Centre	Bordeaux
France	Hôpital du Bocage	Dijon
France	Hôpital Flaubert	Le Havre
France	Hôpital Jeanne de Flandre	Lille
France	Hôpital Debrousse	Lyon
France	Hôpital de la Timone Enfants	Marseille
France	Hôpital Archet 2	Nice
France	Hôpital Necker - Enfants Malades	Paris
France	Hôpital Robert Debré	Paris
France	Hôpital St-Vincent de Paul	Paris
France	Hôpital Trousseau	Paris
France	American Memorial Hospital	Reims
France	Hôpital Charles Nicolle	Rouen
France	Hôpital Hautepierre	Strasbourg
France	Hôpital de la Gespe	Tarbes
France	Hôpital des Enfants	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a GnRH-stimulated LH Level =3 IU/L		3 months after the first injection of triptorelin pamoate 11.25 mg
Secondary	Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was =3 IU/L		Month 6
Secondary	Follicle Stimulating Hormone (FSH) Level Following GnRH Test		Screening, month 3 and 6
Secondary	Basal FSH Level		Month 0, 1, 2, 3, 4, 5, and 6
Secondary	Basal LH Level		Month 0, 1, 2, 3, 4, 5 and 6
Secondary	Number of Girls With Oestradiol Levels = 20 pg/ml		Month 0, 1, 2, 3, 4, 5 and 6
Secondary	Testosterone Level		Month 0, 3 and 6
Secondary	Number of Girls With Inhibin B Levels < 6 pg/ml		Month 0, 3 and 6
Secondary	Change From Screening in Pubertal Stage (Tanner Method) at Month 6	Pubertal stage (graded from 1 to 5 for penis and breast development, graded from 1 to 6 for pubic hair development) according to the Tanner method was collected. A low stage (i.e. 1) corresponds to a pre-pubertal stage and a high stage (i.e. 5 or 6) to an adult stage. Any increase of grade was defined as 'increased' and no change in grade or a reduced grade was defined as 'stabilised or reduced'.	Between screening and month 6
Secondary	Height Standard Deviation Score (SDS)	Standard deviation (SD) is a standard term used in growth studies and represents Standard Deviations calculated as the patient value minus the mean divided by the standard deviation. Standard Deviation Scores vary depending on the age and sex of the child.	Month 0, 3 and 6
Secondary	Body Mass Index (BMI) SDS		Month 0, 3 and 6
Secondary	Change From Baseline in Growth Velocity (GV) SDS at Month 6	Change from baseline of GV was calculated as: GV at month 6 - GV at baseline. GV SDS was calculated using SAS algorithm.; Growth velocity during the study was calculated using the two height measures as: GV = (Height at baseline - Height at screening)*365/delay between two height measures.	Baseline and month 6
Secondary	Difference Between Bone Age and Chronological Age	Bone age was defined according to Greulich and Pyle method. Chronological age was calculated using the date of birth.	Month 0 and 6
Secondary	Uterine Length		Month 0, 3 and 6
Secondary	Triptorelin Plasma Levels		Month 1, 2, 3, 4, 5 and 6