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.
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.
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
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.
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.
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.
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
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.
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First Observatory of Precocious Puberty.
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Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
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A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
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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?
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.