Precocious PubertyPhase 3DECAPUBNCT00909844
Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study
A Phase 3 study testing Triptorelin (I.N.N.) in people with Precocious Puberty, run by Ipsen at 10 sites in France.
Trial summary
The purpose of the protocol is to assess the efficacy of triptorelin 11.25 mg with respect to the proportion of children who maintain a regression or stabilisation of sexual maturity until the end of the study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Precocious Puberty
- What is being tested?
- Triptorelin (I.N.N.)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 10 sitesFrance
- Study dates
- Apr 2008to Jan 2016
- 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
- The child must have completed study 2-54-52014-143
- The child must have an effective response to 2 injections of triptorelin 11.25 mg according to investigator's evaluation with no significant treatment side effects
Who cannot join
- The patient has a known hypersensitivity to any of the test materials or related compounds
- The patient is unable or unwilling to comply fully with the protocol
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Hôpital Hôtel Dieu (CHU)
Angers, 49033
Medical Centre
Bordeaux, 33000
Hôpital Flaubert
Le Havre, 76083
Hôpital Archet II
Nice, 06202
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: Follow-up of the Phase III, Multicentre, Non Comparative, One Single Group, Open Study to Assess the Long-term Efficacy and Tolerability of Pamoate of Triptorelin 11.25 mg in Children With Precocious Puberty
The purpose of the protocol is to assess the efficacy of triptorelin 11.25 mg with respect to the proportion of children who maintain a regression or stabilisation of sexual maturity until the end of the study.
- Conditions
- Precocious Puberty
- Being tested
- Triptorelin (I.N.N.)
- 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 (I.N.N.)Drug
Decapeptyl® SR 11.25mg
| Study group | Role | What they receive |
|---|---|---|
| Triptorelin | Experimental | Not described Receives: Drug: Triptorelin (I.N.N.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Children With a Stabilisation or Regression of Tanner Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0)
The primary objective was to assess efficacy of triptorelin pamoate 11.25 mg with respect to percentage of children maintaining a regression or stabilisation of sexual maturity (based on Tanner breast [girls] or genital [boys] pubertal stage) until end of study. Study treatment lasted until end of the therapeutic period; visits for Months 36 and 48 were optional since a child may have already finished the study at a prior visit. The Final Visit only occurred if the child did not end the study by a complete visit such as at Months 24, 36 or 48. Results are presented only for percentage of girls with regression or stabilisation of Tanner breast pubertal stage (n=34). Since only one boy was included in the study, results for this outcome measure were listed only and no statistical analysis was performed. Please also note additional post-hoc analysis for regression or stabilisation of Tanner breast pubertal stage which applied the variable Last Visit on Treatment instead of Final Visit.
Measured: Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)
Secondary outcomes (12)
Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test
A suppressed LH response to the GnRH test was defined as a stimulated peak of LH ≤3 international units per litre (IU/L). Percentage of patients who had a suppressed LH response to the GnRH test is reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.
Measured: Months -6, 0 and 36
Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA)
Mean levels of oestradiol in girls or testosterone in boys are reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.
Measured: Months -6, 0, 12, 36 and Final Visit (up to 63 months)
Percentage of Patients With a Suppressed Follicle Stimulating Hormone (FSH) Response to GnRH Test
A suppressed FSH response to the GnRH test was defined as a stimulated peak of FSH ≤3 IU/L. Percentage of patients who had a suppressed FSH response to the GnRH test is reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.
Measured: Months -6, 0 and 36
Body Mass Index (BMI) for Chronological Age Variation
Mean changes of BMI from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.
Measured: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
BMI Standard Deviation (SD) Score for Chronological Age Variation
Mean changes of BMI SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.
Measured: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
Auxological Parameters Variations: Height SD Score
Mean changes of height SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.
Measured: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
Auxological Parameters Variations: Growth Velocity SD Score
Mean changes of growth velocity SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.
Measured: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
Auxological Parameters Variations: Weight Variation
Mean changes of weight from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.
Measured: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
Predicted Adult Height SD Score
Mean change of predicted adult height SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented. Also note that data for this endpoint was analysed for girls only.
Measured: Months -6, 0, 12 and Final Visit (up to 63 months)
Bone Age Maturation
Mean change in difference between bone age and chronological age from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.
Measured: Months -6, 0 and Final Visit (up to 63 months)
Percentage of Girls With a Uterine Length < 36 Millimetres (mm)
Percentage of girls who had a uterine length < 36 mm are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.
Measured: Months -6, 0, 12, 24, 36 and Final Visit (up to 63 months)
Percentage of Children With a Stabilisation or Regression of Tanner Pubic Hair Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0)
Pubic hair was measured by the Tanner method on a scale of 1 to 6. A low grade (i.e. 1) corresponds to a pre-pubertal stage and a high grade (i.e. 5 or 6) to an adult stage. Percentage of patients who had stabilisation or regression (no change in grade or a reduced grade) of Tanner pubic hair pubertal stage is reported. Study treatment was to last until the end of the therapeutic period; visits for Months 36 and 48 were optional because if the girl was already 11 and the boy already 13, they would have finished the study at a prior visit. The Final Visit was to occur only if the child did not end the study by a complete visit such as at Months 24, 36 or 48. Please also note the additional post-hoc analysis for percentage of children with a stabilisation or regression of Tanner pubic hair pubertal stage which applied the variable Last Visit on Treatment instead of Final Visit.
Measured: Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startApr 2008
- Primary completionApr 2015
- Study completionJan 2016
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
- 35 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
- NCT00909844
- Sponsor's protocol ID
- 2-54-52014-159
- Other IDs
- 2008-000565-39, 2008
- Acronym
- DECAPUB
- Status last verified
- Jan 2019
- First submitted
- 28 May 2009
- Last updated
- 15 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of the Phase III, Multicentre, Non Comparative, One Single Group, Open Study to Assess the Long-term Efficacy and Tolerability of Pamoate of Triptorelin 11.25 mg in Children With Precocious Puberty
- ClinicalTrials.gov ID
- NCT00909844
- Acronym / sponsor ID
- DECAPUB / 2-54-52014-159
- Conditions
- Precocious Puberty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 May 2009 (estimated)
- Results
- Posted 1 May 2017
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 protocol is to assess the efficacy of triptorelin 11.25 mg with respect to the proportion of children who maintain a regression or stabilisation of sexual maturity until the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triptorelin | Experimental | Drug: Triptorelin (I.N.N.) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The child must have completed study 2-54-52014-143
- The child must have an effective response to 2 injections of triptorelin 11.25 mg according to investigator's evaluation with no significant treatment side effects
Key exclusion criteria (2 listed)
- The patient has a known hypersensitivity to any of the test materials or related compounds
- The patient is unable or unwilling to comply fully with the protocol
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 (I.N.N.)Decapeptyl® SR 11.25mg | Drug | Triptorelin |
Primary outcome
Percentage of Children With a Stabilisation or Regression of Tanner Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0)
Time frame: Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)
The primary objective was to assess efficacy of triptorelin pamoate 11.25 mg with respect to percentage of children maintaining a regression or stabilisation of sexual maturity (based on Tanner breast [girls] or genital [boys] pubertal stage) until end of study. Study treatment lasted until end of the therapeutic period; visits for Months 36 and 48 were optional since a child may have already finished the study at a prior visit. The Final Visit only occurred if the child did not end the study by a complete visit such as at Months 24, 36 or 48. Results are presented only for percentage of girls with regression or stabilisation of Tanner breast pubertal stage (n=34). Since only one boy was included in the study, results for this outcome measure were listed only and no statistical analysis was performed. Please also note additional post-hoc analysis for regression or stabilisation of Tanner breast pubertal stage which applied the variable Last Visit on Treatment instead of Final Visit.
12 secondary outcomes
Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test
Time frame: Months -6, 0 and 36
Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA)
Time frame: Months -6, 0, 12, 36 and Final Visit (up to 63 months)
Percentage of Patients With a Suppressed Follicle Stimulating Hormone (FSH) Response to GnRH Test
Time frame: Months -6, 0 and 36
Body Mass Index (BMI) for Chronological Age Variation
Time frame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
BMI Standard Deviation (SD) Score for Chronological Age Variation
Time frame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
Auxological Parameters Variations: Height SD Score
Time frame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
Auxological Parameters Variations: Growth Velocity SD Score
Time frame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
Auxological Parameters Variations: Weight Variation
Time frame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
Predicted Adult Height SD Score
Time frame: Months -6, 0, 12 and Final Visit (up to 63 months)
Bone Age Maturation
Time frame: Months -6, 0 and Final Visit (up to 63 months)
Percentage of Girls With a Uterine Length < 36 Millimetres (mm)
Time frame: Months -6, 0, 12, 24, 36 and Final Visit (up to 63 months)
Percentage of Children With a Stabilisation or Regression of Tanner Pubic Hair Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0)
Time frame: Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
10 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 (I.N.N.) in people with Precocious Puberty, run by Ipsen at 10 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 2 inclusion and 2 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 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 May 2017). 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?
Percentage of Children With a Stabilisation or Regression of Tanner Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0) (time frame: Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)). 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 15 Jan 2019.