Precocious PubertyPhase 3DECAPUBNCT00564850

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

A Phase 3 study testing Triptorelin pamoate 11.25mg (Decapeptyl® SR) in people with Precocious Puberty, run by Ipsen at 18 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Precocious Puberty
What is being tested?: Triptorelin pamoate 11.25mg (Decapeptyl® SR)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 18 sitesFrance
Study dates: Oct 2007to Oct 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.
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.

Who cannot join

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.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

France18 sites

Hôpital Hotel-Dieu (CHU)
Angers, 49033
Hôpital Saint-Jacques
Besançon, 25030
Medical Centre
Bordeaux, 33000
Hôpital du Bocage
Dijon, 21034
Hôpital Flaubert
Le Havre, 76083
Hôpital Jeanne de Flandre
Lille, 59037
Hôpital Debrousse
Lyon, 69322
Hôpital de la Timone Enfants
Marseille, 13385
Hôpital Archet 2
Nice, 06202
Hôpital Trousseau
Paris, 75012
Hôpital St-Vincent de Paul
Paris, 75014
Hôpital Necker - Enfants Malades
Paris, 75015
Hôpital Robert Debré
Paris, 75019
American Memorial Hospital
Reims, 51092
Hôpital Charles Nicolle
Rouen, 76031
Hôpital Hautepierre
Strasbourg, 67100
Hôpital de la Gespe
Tarbes, 65013
Hôpital des Enfants
Toulouse, 31026

Other trials in France

About this study

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

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: Precocious Puberty
Being tested: Triptorelin pamoate 11.25mg (Decapeptyl® SR)
Medical subject headings: Puberty, Precocious

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00564850
Study group	Role	What they receive
Triptorelin pamoate 11.25mg (Decapeptyl® SR)	Experimental	Not described Receives: Drug: Triptorelin pamoate 11.25mg (Decapeptyl® SR)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L
Measured: 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
Measured: Month 6
Follicle Stimulating Hormone (FSH) Level Following GnRH Test
Measured: Screening, month 3 and 6
Basal FSH Level
Measured: Month 0, 1, 2, 3, 4, 5, and 6
Basal LH Level
Measured: Month 0, 1, 2, 3, 4, 5 and 6
Number of Girls With Oestradiol Levels ≤ 20 pg/ml
Measured: Month 0, 1, 2, 3, 4, 5 and 6
Testosterone Level
Measured: Month 0, 3 and 6
Number of Girls With Inhibin B Levels < 6 pg/ml
Measured: 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'.
Measured: 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.
Measured: Month 0, 3 and 6
Body Mass Index (BMI) SDS
Measured: 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.
Measured: 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.
Measured: Month 0 and 6
Uterine Length
Measured: Month 0, 3 and 6
Triptorelin Plasma Levels
Measured: Month 1, 2, 3, 4, 5 and 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Oct 2010

First posted28 Nov 2007 (estimated)
Study startOct 2007
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Precocious PubertyStudies of the same condition, open and under way.
More trials run by IpsenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

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

IDs, dates and publications

ClinicalTrials.gov ID: NCT00564850
Sponsor's protocol ID: 2-54-52014-143
Other IDs: 2005-005644-11, 2005
Acronym: DECAPUB
Status last verified: Sep 2022
First submitted: 27 Nov 2007
Last updated: 12 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Natural History Study of Patients With Excess Androgen
Congenital Adrenal Hyperplasia (CAH), Familial Male-Limited Precocious Puberty (FMPP)
Active, not recruitingObservational study
First Observatory of Precocious Puberty.
Puberty, Precocious
RecruitingPhase 4
Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
Puberty Changes
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
Active, not recruitingPhase 3
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
Central Precocious Puberty

All Precocious Puberty trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00564850
Acronym / sponsor ID: DECAPUB / 2-54-52014-143
Conditions: Precocious Puberty
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: IpsenIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 28 Nov 2007 (estimated)
Results: Posted 1 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

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

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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.
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).

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

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

Primary outcome

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

14 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
Time frame: Between screening and month 6
Height Standard Deviation Score (SDS)
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
Time frame: Baseline and month 6
Difference Between Bone Age and Chronological Age
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 and safety

Results posted to the registry on 1 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Triptorelin Pamoate 11.25 mg	37	35

Primary outcome: 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. Number. Unit: participants

Measure	Triptorelin Pamoate 11.25 mg n = 37
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

Population analysed: Analyses performed on: * Intention to Treat (ITT): all patients having received ≥1 injection. Any subject with missing data is considered a non-responder. * Modified ITT (mITT): all ITT patients with ≥ Month 3 post-baseline assessment of primary efficacy criterion. * Per Protocol (PP): all mITT patients without major protocol deviations.

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Triptorelin Pamoate 11.25 mg	1 of 37 (2.7%)	7 of 37 (18.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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.

Related trials for Precocious Puberty

RecruitingObservational study
Natural History Study of Patients With Excess Androgen
Congenital Adrenal Hyperplasia (CAH), Familial Male-Limited Precocious Puberty (FMPP)
Active, not recruitingObservational study
First Observatory of Precocious Puberty.
Puberty, Precocious
RecruitingPhase 4
Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
Puberty Changes
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
Active, not recruitingPhase 3
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
Central Precocious Puberty

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ipsen Medical Director study director

Ipsen

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Triptorelin pamoate 11.25mg (Decapeptyl® SR) in people with Precocious Puberty, run by Ipsen at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00564850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.