Trial · NCT05029622
A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.
NCT05029622, Phase 3, Completed, Ipsen; results first posted 2024-05-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty. Trials, record NCT05029622. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05029622
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.
- NCT number
- NCT05029622
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 66 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Central Precocious Puberty
- Interventions
- Triptorelin Pamoate
- First posted
- 2021-08-31
- Last updated
- 2025-02-19
- Other registries' IDs
- eudract:2022-003857-78
- Results first posted
- 2024-05-28
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Luteinising Hormone (LH) Suppression | At Month 6 | LH response was defined as a peak LH \<=5 international units per liter (IU/L) after intravenous (IV) gonadotropin-releasing hormone (GnRH) stimulation. The GnRH stimulation test was performed by using an IV injection of gonadorelin (synthetic GnRH) to stimulate gonadotrophin release and blood samples were collected after the gonadorelin injection for central assessment of serum LH levels. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100. |
| Secondary | Percentage of Participants With LH Response to GnRH Test | At Months 3 and 12 | LH response was defined as a peak LH \<=5 IU/L after IV GnRH stimulation. The GnRH stimulation test was performed by using an IV injection of gonadorelin (synthetic GnRH) to stimulate gonadotrophin release and blood samples were collected after the gonadorelin injection for central assessment of serum LH levels. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100. |
| Secondary | Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | Baseline and at Months 3, 6, 9 and 12 | Basal LH and FSH serum concentrations were analyzed centrally. Change from baseline was defined as the values for LH and FSH at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered. |
| Secondary | Change From Baseline in Peak Serum LH and FSH Level After the GnRH Stimulation Test | Baseline and at Months 3, 6 and 12 | Peak LH and FSH serum concentrations were analyzed centrally. Change from baseline was defined as the values for LH and FSH at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered. Blood samples were collected prior to gonadorelin injection (timepoint T0) and at 30 minutes (T30), 60 minutes (T60) and 90 minutes (T90) after a single IV injection of gonadorelin. A suppressed LH response to GnRH stimulation test was defined as peak serum LH \<=5 IU/L among the four timepoints (T0, T30, T60 and T90). The FSH response to GnRH stimulation was the peak serum FSH level among the four timepoints (T0, T30, T60 and T90). |
| Secondary | Percentage of Participants With LH Response (Peak LH <=5 IU/L) From Month 6 to Month 12 | Month 6 to Month 12 | Peak LH serum concentration was analyzed centrally. LH response was defined as a peak LH \<=5 IU/L after IV GnRH stimulation. The GnRH stimulation test was performed by using an IV injection of gonadorelin (synthetic GnRH) to stimulate gonadotrophin release and blood samples were collected after the gonadorelin injection for central assessment of peak LH levels. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100. |
| Secondary | Percentage of Participants With Prepubertal Levels of Sex Steroids | At Months 3, 6, 9 and 12 | Prepubertal sex steroids assessment included estradiol in female participants and testosterone in male participants. Prepubertal sex steroids levels were defined as: estradiol \<=20 picogram (pg)/ milliliter (mL) in female participants and testosterone \<=30 nanogram (ng)/ deciliter (dL) in male participants. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100. |
| Secondary | Change From Baseline in Mean Height for Age (Z-Score) | Baseline and at Months 6 and 12 | Z-scores are calculated using Centers for Disease Control and Prevention (CDC) Growth Charts. Change from baseline was defined as the values for Z-score at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to study treatment administration. Negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. |
| Secondary | Change From Baseline in Percentile for Height for Age | Baseline and at Months 6 and 12 | Z-scores were calculated using CDC growth charts, that contained Box-Cox transformation (L), the median (M) and the generalized coefficient of variation (S). Percentile was obtained using the following equation M (1 + LSZ) \*\* (1/L), where \*\* indicated an exponent, such that m (1+LSZ)\*\* (1/L) meant raising (1+LSZ) to the (1/L)th power and then multiplying the M. Z was the Z-score that corresponds to the percentile. Negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline was defined as the values for percentile of Z-score at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered. |
| Secondary | Change From Baseline in Growth Velocity | Baseline and at Months 6 and 12 | Growth velocity analysis was part of auxological parameter. Change from baseline was defined as the value for each auxological parameter at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered. |
| Secondary | Percentage of Participants With Bone Age (BA)/Chronological Age (CA) Ratio Not Risen | At Months 6 and 12 | BA was determined using X-rays of the hand and wrist by Greulich and Pyle method. CA was calculated as (visit date -birth date + 1)/365.25. Percentage of response was calculated as n/N\*100, where n was number of participants in the specified category and N was number of participants in the analysis population. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Luteinising Hormone (LH) Suppression | At Month 6 | The ITT population consisted of all participants who received at least 1 dose of study intervention. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With LH Response to GnRH Test | At Months 3 and 12 | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | Baseline and at Months 3, 6, 9 and 12 | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | IU/L | MEAN |
| SECONDARY | Change From Baseline in Peak Serum LH and FSH Level After the GnRH Stimulation Test | Baseline and at Months 3, 6 and 12 | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | IU/L | MEAN |
| SECONDARY | Percentage of Participants With LH Response (Peak LH <=5 IU/L) From Month 6 to Month 12 | Month 6 to Month 12 | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Prepubertal Levels of Sex Steroids | At Months 3, 6, 9 and 12 | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Mean Height for Age (Z-Score) | Baseline and at Months 6 and 12 | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | Z-score | MEAN |
| SECONDARY | Change From Baseline in Percentile for Height for Age | Baseline and at Months 6 and 12 | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | percentiles of Z-score | MEAN |
| SECONDARY | Change From Baseline in Growth Velocity | Baseline and at Months 6 and 12 | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | centimeter (cm)/year | MEAN |
| SECONDARY | Percentage of Participants With Bone Age (BA)/Chronological Age (CA) Ratio Not Risen | At Months 6 and 12 | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | percentage of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group53
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Luteinising Hormone (LH) Suppression | All Participants | 100 | 95% Confidence Interval 94.6 to 100.0 | percentage of participants | |
| Percentage of Participants With LH Response to GnRH Test | All Participants | Month 3 | 97.0 | 95% Confidence Interval 89.5 to 99.6 | percentage of participants |
| Percentage of Participants With LH Response to GnRH Test | All Participants | Month 12 | 98.5 | 95% Confidence Interval 91.8 to 100.0 | percentage of participants |
| Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | All Participants | LH, Month 3 | -1.6420 | Standard Deviation 2.4287 | IU/L |
| Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | All Participants | LH, Month 6 | -1.8015 | Standard Deviation 2.4109 | IU/L |
| Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | All Participants | LH, Month 9 | -1.6307 | Standard Deviation 2.3396 | IU/L |
| Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | All Participants | LH, Month 12 | -1.8504 | Standard Deviation 2.4524 | IU/L |
| Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | All Participants | FSH, Month 3 | -2.9938 | Standard Deviation 1.9450 | IU/L |
| Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | All Participants | FSH, Month 6 | -2.4871 | Standard Deviation 2.0414 | IU/L |
| Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | All Participants | FSH, Month 9 | -2.8586 | Standard Deviation 1.9310 | IU/L |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Participants | 66 | |
| Overall Study | COMPLETED | All Participants | 65 | |
| Overall Study | NOT COMPLETED | All Participants | 1 |
Source ClinicalTrials.gov
Adverse events59
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 | Pyrexia | General disorders | All Participants | 9 | 66 | 9 |
| other | Influenza like illness | General disorders | All Participants | 1 | 66 | 1 |
| other | Vaginal haemorrhage | Reproductive system and breast disorders | All Participants | 2 | 66 | 2 |
| other | Nocturnal emission | Reproductive system and breast disorders | All Participants | 1 | 66 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | All Participants | 7 | 66 | 7 |
| other | Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | All Participants | 3 | 66 | 3 |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | All Participants | 2 | 66 | 2 |
| other | Allergic cough | Respiratory, thoracic and mediastinal disorders | All Participants | 1 | 66 | 1 |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | All Participants | 1 | 66 | 1 |
| other | Listless | Psychiatric disorders | All Participants | 1 | 66 | 1 |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | 0 | 66 |
| Total, other adverse events | All Participants | 59 | 66 |
| Total, serious adverse events | All Participants | 0 | 66 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39412628 | DERIVED |
Source PubMed
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/NCT05029622
GET https://conductscience.org/api/trials/v1/NCT05029622/results?page=2