Trial · NCT00909844
Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study
NCT00909844, Phase 3, Completed, Ipsen; results first posted 2017-05-01
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ConductScience Library. Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study. Trials, record NCT00909844. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00909844
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study
- NCT number
- NCT00909844
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 35 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Precocious Puberty
- Interventions
- Triptorelin (I.N.N.)
- First posted
- 2009-05-29
- Last updated
- 2019-01-15
- Other registries' IDs
- eudract:2008-000565-39
- Results first posted
- 2017-05-01
- Limitations and caveats
Since almost no hormonal data was collected after Baseline and only limited data was collected after Baseline for all other efficacy endpoints, only limited post-Baseline data is reported for the trial overall. All data analysed has been presented.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | 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. |
| Secondary | Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test | Months -6, 0 and 36 | 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. |
| Secondary | Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA) | Months -6, 0, 12, 36 and Final Visit (up to 63 months) | 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. |
| Secondary | Percentage of Patients With a Suppressed Follicle Stimulating Hormone (FSH) Response to GnRH Test | Months -6, 0 and 36 | 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. |
| Secondary | Body Mass Index (BMI) for Chronological Age Variation | Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) | 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. |
| Secondary | BMI Standard Deviation (SD) Score for Chronological Age Variation | Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) | 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. |
| Secondary | Auxological Parameters Variations: Height SD Score | Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) | 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. |
| Secondary | Auxological Parameters Variations: Growth Velocity SD Score | Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) | 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. |
| Secondary | Auxological Parameters Variations: Weight Variation | Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) | 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. |
| Secondary | Predicted Adult Height SD Score | Months -6, 0, 12 and Final Visit (up to 63 months) | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months) | Analysis performed on female patients in the ITT population, consisting of all enrolled female patients who received at least one injection of study treatment in this follow up study. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test | Months -6, 0 and 36 | Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported. | percentage of patients | NUMBER |
| SECONDARY | Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA) | Months -6, 0, 12, 36 and Final Visit (up to 63 months) | Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported. | picograms per millilitre (pg/mL) | MEAN |
| SECONDARY | Percentage of Patients With a Suppressed Follicle Stimulating Hormone (FSH) Response to GnRH Test | Months -6, 0 and 36 | Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported. | percentage of patients | NUMBER |
| SECONDARY | Body Mass Index (BMI) for Chronological Age Variation | Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) | Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported. | kilograms per metre squared (kg/m^2) | MEAN |
| SECONDARY | BMI Standard Deviation (SD) Score for Chronological Age Variation | Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) | Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported. | SD score | MEAN |
| SECONDARY | Auxological Parameters Variations: Height SD Score | Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) | Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported. | SD score | MEAN |
| SECONDARY | Auxological Parameters Variations: Growth Velocity SD Score | Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) | Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported. | SD score | MEAN |
| SECONDARY | Auxological Parameters Variations: Weight Variation | Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) | Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported. | kg | MEAN |
| SECONDARY | Predicted Adult Height SD Score | Months -6, 0, 12 and Final Visit (up to 63 months) | Analysis performed on female patients in the ITT population, consisting of all enrolled female patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported. | SD score | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | Triptorelin Pamoate 11.25 mg | Compared to Pretreatment (Month -6) | 61.8 | 95% Confidence Interval 43.56 to 77.83 | percentage of patients |
| 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) | Triptorelin Pamoate 11.25 mg | Compared to Baseline (Month 0) | 52.9 | 95% Confidence Interval 35.13 to 70.22 | percentage of patients |
| Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test | Triptorelin Pamoate 11.25 mg | Pretreatment (Month -6) | 0 | 95% Confidence Interval NA to NA | percentage of patients |
| Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test | Triptorelin Pamoate 11.25 mg | Baseline (Month 0) | 91.4 | 95% Confidence Interval 76.94 to 98.20 | percentage of patients |
| Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test | Triptorelin Pamoate 11.25 mg | Month 36 | 100 | 95% Confidence Interval 2.50 to 100.00 | percentage of patients |
| Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA) | Triptorelin Pamoate 11.25 mg | Oestradiol at Pretreatment (Girls) | 18.59 | Standard Deviation 9.79 | picograms per millilitre (pg/mL) |
| Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA) | Triptorelin Pamoate 11.25 mg | Oestradiol at Baseline (Girls) | 8.71 | Standard Deviation 4.51 | picograms per millilitre (pg/mL) |
| Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA) | Triptorelin Pamoate 11.25 mg | Oestradiol at Month 12 (Girls) | 2.50 | Standard Deviation NA | picograms per millilitre (pg/mL) |
| Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA) | Triptorelin Pamoate 11.25 mg | Oestradiol at Month 36 (Girls) | 12.20 | Standard Deviation NA | picograms per millilitre (pg/mL) |
| Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA) | Triptorelin Pamoate 11.25 mg | Oestradiol at Final Visit (Girls) | 10.00 | Standard Deviation NA | picograms per millilitre (pg/mL) |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Triptorelin Pamoate 11.25 mg | 35 | |
| Overall Study | COMPLETED | Triptorelin Pamoate 11.25 mg | 31 | |
| Overall Study | NOT COMPLETED | Triptorelin Pamoate 11.25 mg | 4 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Triptorelin Pamoate 11.25 mg | 6 | 35 | 9 |
| other | Vomiting | Gastrointestinal disorders | Triptorelin Pamoate 11.25 mg | 2 | 35 | 2 |
| other | Injection site pain | General disorders | Triptorelin Pamoate 11.25 mg | 4 | 35 | 6 |
| other | Insomnia | Psychiatric disorders | Triptorelin Pamoate 11.25 mg | 2 | 35 | 2 |
| other | Pelvic pain | Reproductive system and breast disorders | Triptorelin Pamoate 11.25 mg | 2 | 35 | 2 |
| other | Vaginal haemorrhage | Reproductive system and breast disorders | Triptorelin Pamoate 11.25 mg | 2 | 35 | 2 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Triptorelin Pamoate 11.25 mg | 2 | 35 | 2 |
| other | Headache | Nervous system disorders | Triptorelin Pamoate 11.25 mg | 3 | 35 | 3 |
| other | Hot flush | Vascular disorders | Triptorelin Pamoate 11.25 mg | 3 | 35 | 3 |
| other | Weight increased | Investigations | Triptorelin Pamoate 11.25 mg | 2 | 35 | 2 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Triptorelin Pamoate 11.25 mg | ||
| Total, other adverse events | Triptorelin Pamoate 11.25 mg | 16 | 35 |
| Total, serious adverse events | Triptorelin Pamoate 11.25 mg | 3 | 35 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00909844
GET https://conductscience.org/api/trials/v1/NCT00909844/results?page=2