Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name DECAPUB

NCTNCT00564850Other id2-54-52014-143Other id2005-005644-11Other id2005

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 37 participants (actual)
Sponsor: Ipsen · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
France
Start: Oct 2007
Primary completion: Oct 2010
Completion: Oct 2010
First posted: 28 Nov 2007 (estimated)
Last update posted: 12 Oct 2022
Conditions: Precocious Puberty

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20072008200920102011

Ph 3
DECAPUB
NCT00564850
Oct 2007 to Oct 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Triptorelin pamoate 11.25mg (Decapeptyl® SR)Drug

Arms1

Experimental
Triptorelin pamoate 11.25mg (Decapeptyl® SR)

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L
Time frame · 3 months after the first injection of triptorelin pamoate 11.25 mg

Secondary outcomes(14)

Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L
Time frame · Month 6
Follicle Stimulating Hormone (FSH) Level Following GnRH Test
Time frame · Screening, month 3 and 6
Basal FSH Level
Time frame · Month 0, 1, 2, 3, 4, 5, and 6
Basal LH Level
Time frame · Month 0, 1, 2, 3, 4, 5 and 6
Number of Girls With Oestradiol Levels ≤ 20 pg/ml
Time frame · Month 0, 1, 2, 3, 4, 5 and 6
Testosterone Level
Time frame · Month 0, 3 and 6
Number of Girls With Inhibin B Levels < 6 pg/ml
Time frame · Month 0, 3 and 6
Change From Screening in Pubertal Stage (Tanner Method) at Month 6
Time frame · Between screening and month 6
Registry description
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'.
Height Standard Deviation Score (SDS)
Time frame · Month 0, 3 and 6
Registry description
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.
Body Mass Index (BMI) SDS
Time frame · Month 0, 3 and 6
Change From Baseline in Growth Velocity (GV) SDS at Month 6
Time frame · Baseline and month 6
Registry description
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.
Difference Between Bone Age and Chronological Age
Time frame · Month 0 and 6
Registry description
Bone age was defined according to Greulich and Pyle method. Chronological age was calculated using the date of birth.
Uterine Length
Time frame · Month 0, 3 and 6
Triptorelin Plasma Levels
Time frame · Month 1, 2, 3, 4, 5 and 6

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 3 months after the first injection of triptorelin pamoate 11.25 mg

Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L

Group	Value (participants)
Triptorelin Pamoate 11.25 mg	31

Secondary and other outcome results(7)

Secondary outcomeNumber· Month 6

Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L

Group	Value (participants)
Triptorelin Pamoate 11.25 mg	32

Secondary outcomeMean· Screening, month 3 and 6

Follicle Stimulating Hormone (FSH) Level Following GnRH Test

Group	Value (IU/L)	Spread
Triptorelin Pamoate 11.25 mg	11.84	3.23

Secondary outcomeMean· Month 0, 1, 2, 3, 4, 5, and 6

Basal FSH Level

Group	Value (IU/L)	Spread
Triptorelin Pamoate 11.25 mg	4.13	2.65

Secondary outcomeMean· Month 0, 1, 2, 3, 4, 5 and 6

Basal LH Level

Group	Value (IU/L)	Spread
Triptorelin Pamoate 11.25 mg	1.49	1.78

Secondary outcomeNumber· Month 0, 1, 2, 3, 4, 5 and 6

Number of Girls With Oestradiol Levels ≤ 20 pg/ml

Group	Value (participants)
Triptorelin Pamoate 11.25 mg	22

Secondary outcomeNumber· Month 0, 3 and 6

Testosterone Level

Group	Value (ng/ml)
Triptorelin Pamoate 11.25 mg	2.0

Secondary outcomeNumber· Month 0, 3 and 6

Number of Girls With Inhibin B Levels < 6 pg/ml

Group	Value (participants)
Triptorelin Pamoate 11.25 mg	18

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Triptorelin Pamoate 11.25 mg11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.	–	1 / 37	7 / 37

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: Not stated
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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