Trial · NCT04736602
Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty.
NCT04736602, Phase 3, Completed, Ipsen; results first posted 2024-08-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty. Trials, record NCT04736602. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04736602
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty.
- NCT number
- NCT04736602
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 32 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Central Precocious Puberty
- Interventions
- Triptorelin pamoate 15mg
- First posted
- 2021-02-03
- Last updated
- 2024-08-01
- Results first posted
- 2024-08-01
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 After Gonadotropin-Releasing Hormone (GnRH) Stimulation | At Month 3 | The LH suppression was defined as stimulated peak LH ≤3 International Units/Liter (IU/L). The GnRH stimulation test was performed by using an intravenous (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. |
| Secondary | Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels | Baseline (Day 1) and at Months 3, 6, 9 and 12 | Basal LH and FSH serum concentrations were analyzed centrally. Change from baseline was defined as the value for LH and FSH levels at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered. |
| Secondary | Percentage of Participants With LH Suppression After GnRH Stimulation | At Months 6 and 12 | A synthetic GnRH (gonadorelin) was used for gonadotrophin stimulation. Blood samples were collected prior to gonadorelin injection (timepoint T0) and at 30 minutes (T30), 60 minutes (T60) and 90 minutes (T90) (±5 minutes at each timepoint) after a single IV injection of gonadorelin. A suppressed LH response to GnRH stimulation test was defined as peak LH ≤3 IU/L among the 4 timepoints T0, T30, T60 and T90). |
| Secondary | Change From Baseline in Peak LH and FSH Level After GnRH Stimulation | Baseline (Day 1) and at Months 3, 6 and 12 | A synthetic GnRH was used for gonadotrophin stimulation. Blood samples were collected prior to gonadorelin injection (timepoint T0) and at 30 minutes (T30), 60 minutes (T60) and 90 minutes (T90) (±5 minutes at each timepoint) after a single IV injection of gonadorelin. The FSH response to GnRH stimulation was the peak FSH level among the 4 timepoints (T0, T30, T60 and T90). The LH response to GnRH stimulation test was defined as peak LH ≤3 IU/L among the 4 timepoints T0, T30, T60 and T90). Baseline was defined as the last non-missing measurement taken prior to the first dose administered. |
| 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 ≤0.3 nanogram (ng)/mL in male participants. |
| Secondary | Change From Baseline in Estradiol Levels | Baseline (Day 1) and at Months 3, 6 ,9 and 12 | Estradiol serum concentration was analyzed centrally. Change from baseline was defined as the value for estradiol levels at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered. |
| Secondary | Change From Baseline in Testosterone Levels | Baseline (Day 1) and at Months 3, 6 ,9 and 12 | Testosterone serum concentration was analyzed centrally. Change from baseline was defined as the value for testosterone levels at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered. |
| Secondary | Percentage of Participants With Change From Baseline in Pubertal Stage | Baseline (Day 1) and at Months 6 and 12 | Pubertal stage parameters were analyzed using Tanner method. Pubertal stage parameters included genital stage in male participants, breast stage in female participants and pubic hair stage in both sexes. |
| Secondary | Percentage of Participants With Stabilized Pubertal Stage Compared to Baseline | Baseline (Day 1) and at Months 6 and 12 | Pubertal stage parameters were analyzed using Tanner method. Pubertal stage parameters included genital stage in male participants, breast stage in female participants and pubic hair stage in both sexes. |
| Secondary | Change From Baseline in Auxological Parameter: Height | Baseline (Day 1) and at Months 3, 6, 9 and 12 | Auxological parameter including height was analyzed. 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 dose administered. |
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 After Gonadotropin-Releasing Hormone (GnRH) Stimulation | At Month 3 | The modified ITT (mITT) population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels | Baseline (Day 1) and at Months 3, 6, 9 and 12 | The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported. | IU/L | MEAN |
| SECONDARY | Percentage of Participants With LH Suppression After GnRH Stimulation | At Months 6 and 12 | The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Peak LH and FSH Level After GnRH Stimulation | Baseline (Day 1) and at Months 3, 6 and 12 | The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported. | IU/L | MEAN |
| SECONDARY | Percentage of Participants With Prepubertal Levels of Sex Steroids | At Months 3, 6, 9 and 12 | The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Estradiol Levels | Baseline (Day 1) and at Months 3, 6 ,9 and 12 | The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data for female participants were analyzed. | pg/mL | MEAN |
| SECONDARY | Change From Baseline in Testosterone Levels | Baseline (Day 1) and at Months 3, 6 ,9 and 12 | The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data for male participants were analyzed. | ng/mL | MEAN |
| SECONDARY | Percentage of Participants With Change From Baseline in Pubertal Stage | Baseline (Day 1) and at Months 6 and 12 | The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Stabilized Pubertal Stage Compared to Baseline | Baseline (Day 1) and at Months 6 and 12 | The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Auxological Parameter: Height | Baseline (Day 1) and at Months 3, 6, 9 and 12 | The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported. | centimeter (cm) | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group95
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 After Gonadotropin-Releasing Hormone (GnRH) Stimulation | All Participants | 100 | 90% Confidence Interval 90.8 to 100 | percentage of participants | |
| Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels | All Participants | LH, Month 3 | -0.6906 | Standard Deviation 1.6417 | IU/L |
| Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels | All Participants | LH, Month 6 | -0.7411 | Standard Deviation 1.6606 | IU/L |
| Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels | All Participants | LH, Month 9 | -0.7415 | Standard Deviation 1.6817 | IU/L |
| Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels | All Participants | LH, Month 12 | -0.9310 | Standard Deviation 1.6367 | IU/L |
| Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels | All Participants | FSH, Month 3 | -2.3531 | Standard Deviation 1.8079 | IU/L |
| Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels | All Participants | FSH, Month 6 | -2.2307 | Standard Deviation 1.7445 | IU/L |
| Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels | All Participants | FSH, Month 9 | -2.0740 | Standard Deviation 1.7979 | IU/L |
| Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels | All Participants | FSH, Month 12 | -1.9413 | Standard Deviation 1.6996 | IU/L |
| Percentage of Participants With LH Suppression After GnRH Stimulation | All Participants | Month 6 | 93.5 | 90% Confidence Interval 81.1 to 98.8 | percentage of participants |
1 to 10 of 95Source ClinicalTrials.gov
See all 95 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Study Phase | STARTED | All Participants | 32 | |
| Main Study Phase | COMPLETED | All Participants | 30 | |
| Main Study Phase | NOT COMPLETED | All Participants | 2 | |
| Extension Phase | STARTED | All Participants | 30 | |
| Extension Phase | COMPLETED | All Participants | 29 | |
| Extension Phase | NOT COMPLETED | All Participants | 1 |
Source ClinicalTrials.gov
Adverse events48
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 | Upper respiratory tract infection | Infections and infestations | All Participants | 10 | 32 | 15 |
| other | Bronchitis | Infections and infestations | All Participants | 3 | 32 | 4 |
| other | Tonsillitis | Infections and infestations | All Participants | 2 | 32 | 2 |
| other | Gastroenteritis | Infections and infestations | All Participants | 1 | 32 | 1 |
| other | Gingivitis | Infections and infestations | All Participants | 1 | 32 | 1 |
| other | Hordeolum | Infections and infestations | All Participants | 1 | 32 | 1 |
| other | Parotitis | Infections and infestations | All Participants | 1 | 32 | 1 |
| other | Pneumonia | Infections and infestations | All Participants | 1 | 32 | 1 |
| other | Respiratory tract infection | Infections and infestations | All Participants | 1 | 32 | 1 |
| other | Rhinitis | Infections and infestations | All Participants | 1 | 32 | 1 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | 0 | 32 |
| Total, other adverse events | All Participants | 27 | 32 |
| Total, serious adverse events | All Participants | 2 | 32 |
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/NCT04736602
GET https://conductscience.org/api/trials/v1/NCT04736602/results?page=2