Phase 3 N=37 Treatment

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

Precocious Puberty

Bottom Line

View on ClinicalTrials.gov: NCT00564850 ↗

Enrolled (actual)

Serious AEs

2.7%

Results posted

Dec 2011

Primary outcome: Primary: Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L — 31; 6; 31; 3 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Triptorelin pamoate 11.25mg (Decapeptyl® SR) (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Ipsen
Primary completion: Oct 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L	31; 6; 31; 3; 30; 2	—
SECONDARY Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L	32; 5	—
SECONDARY Follicle Stimulating Hormone (FSH) Level Following GnRH Test	11.84; 2.26; 2.34	—
SECONDARY Basal FSH Level	4.13; 0.67; 1.07; 1.11; 0.78; 1.41	—
SECONDARY Basal LH Level	1.49; 0.42; 0.42; 0.43; 0.43; 0.48	—
SECONDARY Number of Girls With Oestradiol Levels ≤ 20 pg/ml	22; 14; 34; 0; 34; 1	—
SECONDARY Testosterone Level	2.0; 0.12; 0.16	—
SECONDARY Number of Girls With Inhibin B Levels < 6 pg/ml	18; 18; 33; 1; 32; 2	—
SECONDARY Change From Screening in Pubertal Stage (Tanner Method) at Month 6	30; 5; 32; 2; 1; 0	—
SECONDARY Height Standard Deviation Score (SDS)	1.25; 1.32; 1.32	—
SECONDARY Body Mass Index (BMI) SDS	0.58; 0.64; 0.60	—
SECONDARY Change From Baseline in Growth Velocity (GV) SDS at Month 6	-1.95	—
SECONDARY Difference Between Bone Age and Chronological Age	2.09; 2.02	—
SECONDARY Uterine Length	37.6; 37.4; 36.8	—
SECONDARY Triptorelin Plasma Levels	0.187; 0.048; 0.034; 0.201; 0.045; 0.030	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00564850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.