CompletedNCT00564850DECAPUBUpdated Oct 12, 2022Results posted

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

A Phase 3 interventional study of Triptorelin pamoate 11.25mg (Decapeptyl® SR) in Precocious Puberty, sponsored by Ipsen. Completed at 18 sites in France. Per ClinicalTrials.gov, last updated 2022-10-12.

Sponsored by Ipsen · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 37
Allocation: Not applicable
Sex: All

Study 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.

Conditions studied

Precocious Puberty

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Puberty, Precocious 75

In context

Puberty, Precocious

75 studies on the registry are indexed under Puberty, Precocious; 19 are open to participants now.

This study's enrollment of 37 is below the median of 64 across 47 interventional studies indexed under Puberty, Precocious.

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Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 37 participants (actual)

Study arms

Experimental
Triptorelin pamoate 11.25mg (Decapeptyl® SR)
Drug: Triptorelin pamoate 11.25mg (Decapeptyl® SR)

Interventions

DrugTriptorelin pamoate 11.25mg (Decapeptyl® SR)
One intra muscular injection at day 1 and month 3.

What researchers measure

Primary outcomes

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

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
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'.
Time frame: Between screening and month 6
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.
Time frame: Month 0, 3 and 6
Body Mass Index (BMI) SDS
Time frame: Month 0, 3 and 6
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.
Time frame: Baseline and month 6
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.
Time frame: Month 0 and 6
Uterine Length
Time frame: Month 0, 3 and 6
Triptorelin Plasma Levels
Time frame: Month 1, 2, 3, 4, 5 and 6

Results

Posted Dec 1, 2011

Participant flow

62 participants were screened, of which 37 met the study's entry criteria and received at least one dose of investigational medicinal product. 25 participants failed screening. Participants were recruited from October 2007 at 18 Hospital clinics across France.

Participant flow — Overall Study
Milestone	Triptorelin Pamoate 11.25 mg
Started	37
Completed	35
Not completed	2
Withdrew: Protocol violation	2

Outcome measures

PrimaryNumber 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
Reported as:: Number · participants

Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L
participants	Triptorelin Pamoate 11.25 mg
Yes [ITT (n=37)]	31 (68.0 to 93.8)
No [ITT (n=37)]	6
Yes [mITT (n=34)]	31 (76.3 to 98.1)
No [mITT (n=34)]	3
Yes [PP (n=32)]	30 (79.2 to 99.2)
No [PP (n=32)]	2

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

Time frame:: Month 6
Reported as:: Number · participants

Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L
participants	Triptorelin Pamoate 11.25 mg
Yes (n=37)	32 (71.2 to 95.5)
No (n=37)	5

SecondaryFollicle Stimulating Hormone (FSH) Level Following GnRH Test

Time frame:: Screening, month 3 and 6
Reported as:: Mean · IU/L

Follicle Stimulating Hormone (FSH) Level Following GnRH Test
IU/L	Triptorelin Pamoate 11.25 mg
Screening (n=37)	11.84 ± 3.23
Month 3 (n=34)	2.26 ± 2.5
Month 6 (n=35)	2.34 ± 1.65

SecondaryBasal FSH Level

Time frame:: Month 0, 1, 2, 3, 4, 5, and 6
Reported as:: Mean · IU/L

Basal FSH Level
IU/L	Triptorelin Pamoate 11.25 mg
Month 0 (screening, n=37)	4.13 ± 2.65
Month 1 (n=35)	0.67 ± 0.53
Month 2 (n=36)	1.07 ± 0.82
Month 3 (n=35)	1.11 ± 0.73
Month 4 (n=35)	0.78 ± 0.39
Month 5 (n=34)	1.41 ± 2.09
Month 6 (n=35)	1.36 ± 1.24

SecondaryBasal LH Level

Time frame:: Month 0, 1, 2, 3, 4, 5 and 6
Reported as:: Mean · IU/L

Basal LH Level
IU/L	Triptorelin Pamoate 11.25 mg
Month 0 (screening, n=37)	1.49 ± 1.78
Month 1 (n=35)	0.42 ± 0.22
Month 2 (n=36)	0.42 ± 0.31
Month 3 (n=35)	0.43 ± 0.27
Month 4 (n=35)	0.43 ± 0.23
Month 5 (n=34)	0.48 ± 0.70
Month 6 (n=35)	0.44 ± 0.42

SecondaryNumber of Girls With Oestradiol Levels ≤ 20 pg/ml

Time frame:: Month 0, 1, 2, 3, 4, 5 and 6
Reported as:: Number · participants

Number of Girls With Oestradiol Levels ≤ 20 pg/ml
participants	Triptorelin Pamoate 11.25 mg
Yes - month 0 (n=36)	22
No - month 0 (n=36)	14
Yes - month 1 (n=34)	34 (89.7 to 99.9)
No - month 1 (n=34)	0
Yes - month 2 (n=35)	34 (85.1 to 99.9)
No - month 2 (n=35)	1
Yes - month 3 (n=34)	33 (84.7 to 99.9)
No - month 3 (n=34)	1
Yes - month 4 (n=34)	34 (89.7 to 100)
No - month 4 (n=34)	0
Yes - month 5 (n=33)	33 (89.4 to 100)
No - month 5 (n=33)	0
Yes - month 6 (n=34)	33 (84.7 to 99.9)
No - month 6 (n=34)	1

SecondaryTestosterone Level

Time frame:: Month 0, 3 and 6
Reported as:: Number · ng/ml

Testosterone Level
ng/ml	Triptorelin Pamoate 11.25 mg
Month 0 (screening)	2.0
Month 3	0.12
Month 6	0.16

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

Time frame:: Month 0, 3 and 6
Reported as:: Number · participants

Number of Girls With Inhibin B Levels < 6 pg/ml
participants	Triptorelin Pamoate 11.25 mg
Yes - month 0 (screening, n=36)	18
No - month 0 (screening, n=36)	18
Yes - month 3 (n=34)	33 (84.7 to 99.9)
No - month 3 (n=34)	1
Yes - month 6 (n=34)	32 (80.3 to 99.3)
No - month 6 (n=34)	2

SecondaryChange 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'.

Time frame:: Between screening and month 6
Reported as:: Number · participants

Change From Screening in Pubertal Stage (Tanner Method) at Month 6
participants	Triptorelin Pamoate 11.25 mg
Pubic hair stage stabilised or reduced (n=35)	30
Pubic hair stage increased (n=35)	5
Breast stage stabilised or reduced (n=34)	32
Breast stage increased (n=34)	2
Penis stage stabilised or reduced (n=1)	1
Penis stage increased (n=1)	0

SecondaryHeight 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.

Time frame:: Month 0, 3 and 6
Reported as:: Mean · SD score

Height Standard Deviation Score (SDS)
SD score	Triptorelin Pamoate 11.25 mg
Month 0 (baseline, n=37)	1.25 ± 1.14
Month 3 (n=37)	1.32 ± 1.16
Month 6 (n=35)	1.32 ± 1.16

SecondaryBody Mass Index (BMI) SDS

Time frame:: Month 0, 3 and 6
Reported as:: Mean · SD score

Body Mass Index (BMI) SDS
SD score	Triptorelin Pamoate 11.25 mg
Month 0 (baseline, n=36)	0.58 ± 0.85
Month 3 (n=37)	0.64 ± 0.89
Month 6 (n=35)	0.60 ± 0.78

SecondaryChange 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.

Time frame:: Baseline and month 6
Reported as:: Mean · SD score

Change From Baseline in Growth Velocity (GV) SDS at Month 6
SD score	Triptorelin Pamoate 11.25 mg
Change From Baseline in Growth Velocity (GV) SDS at Month 6	-1.95 ± 2.07

SecondaryDifference 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.

Time frame:: Month 0 and 6
Reported as:: Mean · years

Difference Between Bone Age and Chronological Age
years	Triptorelin Pamoate 11.25 mg
Month 0 (screening, n=37)	2.09 ± 0.91
Month 6 (n=33)	2.02 ± 0.88

SecondaryUterine Length

Time frame:: Month 0, 3 and 6
Reported as:: Mean · mm

Uterine Length
mm	Triptorelin Pamoate 11.25 mg
Month 0 (screening, n=35)	37.6 ± 10.6
Month 3 (n=34)	37.4 ± 8.2
Month 6 (n=34)	36.8 ± 6.9

SecondaryTriptorelin Plasma Levels

Time frame:: Month 1, 2, 3, 4, 5 and 6
Reported as:: Mean · ng/mL

Triptorelin Plasma Levels
ng/mL	Triptorelin Pamoate 11.25 mg
Month 1 (n=35)	0.187 ± 0.115
Month 2 (n=36)	0.048 ± 0.023
Month 3 (n=35)	0.034 ± 0.018
Month 4 (n=34)	0.201 ± 0.120
Month 5 (n=33)	0.045 ± 0.023
Month 6 (n=35)	0.030 ± 0.017

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Triptorelin Pamoate 11.25 mg	—	1/37 (2.7%)	7/37 (18.9%)

Most frequent serious events

Most frequent serious events
Event	Triptorelin Pamoate 11.25 mg
Foot fractureInjury, poisoning and procedural complications	1/37

Most frequent other events

Most frequent other events
Event	Triptorelin Pamoate 11.25 mg
Abdominal painGastrointestinal disorders	4/37
Injection site painGeneral disorders	2/37
Hot flushVascular disorders	2/37

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Triptorelin Pamoate 11.25 mg
<=18 years	37
Between 18 and 65 years	0
>=65 years	0

Age, Continuous
Age, Continuous(years)	Triptorelin Pamoate 11.25 mg
Mean	8.2 ± 1.1

Sex: Female, Male
Sex: Female, Male(Participants)	Triptorelin Pamoate 11.25 mg
Female	36
Male	1

Region of Enrollment
Region of Enrollment(participants)	Triptorelin Pamoate 11.25 mg
France	37

Weight
Weight(Kg)	Triptorelin Pamoate 11.25 mg
Mean	32.76 ± 7.36

Study locations

18 sites

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 Trousseau
Paris, 75012, France
Hôpital St-Vincent de Paul
Paris, 75014, France
Hôpital Necker - Enfants Malades
Paris, 75015, France
Hôpital Robert Debré
Paris, 75019, 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

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00564850
Lead sponsor: Ipsen
Responsible party: Sponsor
First posted: Nov 28, 2007
Start date: Oct 2007
Primary completion: Oct 2010
Completion: Oct 2010
Results posted: Dec 1, 2011
Last update: Oct 12, 2022

Study contacts

Ipsen Medical Director

study director · Ipsen

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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