Trial · NCT00564850
Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty
NCT00564850, Phase 3, Completed, Ipsen; results first posted 2011-12-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty. Trials, record NCT00564850. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00564850
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty
- NCT number
- NCT00564850
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 37 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Precocious Puberty
- Interventions
- Triptorelin pamoate 11.25mg (Decapeptyl® SR)
- First posted
- 2007-11-28
- Last updated
- 2022-10-12
- Other registries' IDs
- eudract:2005-005644-11
- Results first posted
- 2011-12-01
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L | 3 months after the first injection of triptorelin pamoate 11.25 mg | |
| Secondary | Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L | Month 6 | |
| Secondary | Follicle Stimulating Hormone (FSH) Level Following GnRH Test | Screening, month 3 and 6 | |
| Secondary | Basal FSH Level | Month 0, 1, 2, 3, 4, 5, and 6 | |
| Secondary | Basal LH Level | Month 0, 1, 2, 3, 4, 5 and 6 | |
| Secondary | Number of Girls With Oestradiol Levels ≤ 20 pg/ml | Month 0, 1, 2, 3, 4, 5 and 6 | |
| Secondary | Testosterone Level | Month 0, 3 and 6 | |
| Secondary | Number of Girls With Inhibin B Levels < 6 pg/ml | Month 0, 3 and 6 | |
| Secondary | Change From Screening in Pubertal Stage (Tanner Method) at Month 6 | Between screening and 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'. |
| Secondary | Height Standard Deviation Score (SDS) | Month 0, 3 and 6 | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L | 3 months after the first injection of triptorelin pamoate 11.25 mg | 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. | participants | NUMBER |
| SECONDARY | Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L | Month 6 | Analysis was performed on Intention to Treat population (ITT) defined as all participants having received at least one injection of 11.25 mg triptorelin pamoate. n indicates the number of patients who had an assessment at the visit. | participants | NUMBER |
| SECONDARY | Follicle Stimulating Hormone (FSH) Level Following GnRH Test | Screening, month 3 and 6 | Analysis was performed on the ITT population. 3 participants and 2 participants had missing data at month 3 and month 6 respectively. | IU/L | MEAN |
| SECONDARY | Basal FSH Level | Month 0, 1, 2, 3, 4, 5, and 6 | Analysis was performed on the ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 and 3 participants had missing data at month 2 and month 5 respectively. | IU/L | MEAN |
| SECONDARY | Basal LH Level | Month 0, 1, 2, 3, 4, 5 and 6 | Analysis was performed on ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 and 3 participants had missing data at month 2 and month 5 respectively. | IU/L | MEAN |
| SECONDARY | Number of Girls With Oestradiol Levels ≤ 20 pg/ml | Month 0, 1, 2, 3, 4, 5 and 6 | Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 participant and 3 participants had missing data at month 2 and 5 respectively. | participants | NUMBER |
| SECONDARY | Testosterone Level | Month 0, 3 and 6 | Testosterone level from the male patient in the ITT population. | ng/ml | NUMBER |
| SECONDARY | Number of Girls With Inhibin B Levels < 6 pg/ml | Month 0, 3 and 6 | Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 3 and month 6. | participants | NUMBER |
| SECONDARY | Change From Screening in Pubertal Stage (Tanner Method) at Month 6 | Between screening and month 6 | Analysis was performed on the ITT population. 2 participants had missing data for pubic hair stage and breast stage. | participants | NUMBER |
| SECONDARY | Height Standard Deviation Score (SDS) | Month 0, 3 and 6 | Analysis was performed on the ITT population. 2 participants had missing data at month 6. | SD score | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L | Triptorelin Pamoate 11.25 mg | Yes [ITT (n=37)] | 31 | 68.0 to 93.8 | participants |
| Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L | Triptorelin Pamoate 11.25 mg | No [ITT (n=37)] | 6 | participants | |
| Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L | Triptorelin Pamoate 11.25 mg | Yes [mITT (n=34)] | 31 | 76.3 to 98.1 | participants |
| Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L | Triptorelin Pamoate 11.25 mg | No [mITT (n=34)] | 3 | participants | |
| Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L | Triptorelin Pamoate 11.25 mg | Yes [PP (n=32)] | 30 | 79.2 to 99.2 | participants |
| Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L | Triptorelin Pamoate 11.25 mg | No [PP (n=32)] | 2 | participants | |
| Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L | Triptorelin Pamoate 11.25 mg | Yes (n=37) | 32 | 71.2 to 95.5 | participants |
| Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L | Triptorelin Pamoate 11.25 mg | No (n=37) | 5 | participants | |
| Follicle Stimulating Hormone (FSH) Level Following GnRH Test | Triptorelin Pamoate 11.25 mg | Screening (n=37) | 11.84 | Standard Deviation 3.23 | IU/L |
| Follicle Stimulating Hormone (FSH) Level Following GnRH Test | Triptorelin Pamoate 11.25 mg | Month 3 (n=34) | 2.26 | Standard Deviation 2.5 | IU/L |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 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 | 37 | |
| Overall Study | COMPLETED | Triptorelin Pamoate 11.25 mg | 35 | |
| Overall Study | NOT COMPLETED | Triptorelin Pamoate 11.25 mg | 2 |
Source ClinicalTrials.gov
Adverse events4
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 | 4 | 37 | 4 |
| other | Injection site pain | General disorders | Triptorelin Pamoate 11.25 mg | 2 | 37 | 2 |
| other | Hot flush | Vascular disorders | Triptorelin Pamoate 11.25 mg | 2 | 37 | 2 |
| serious | Foot fracture | Injury, poisoning and procedural complications | Triptorelin Pamoate 11.25 mg | 1 | 37 | 1 |
Source ClinicalTrials.gov
Adverse 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 | 7 | 37 |
| Total, serious adverse events | Triptorelin Pamoate 11.25 mg | 1 | 37 |
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/NCT00564850
GET https://conductscience.org/api/trials/v1/NCT00564850/results?page=2