Trial · NCT01467882
Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty
NCT01467882, Phase 3, Completed, Debiopharm International SA; results first posted 2015-09-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty. Trials, record NCT01467882. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01467882
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty
- NCT number
- NCT01467882
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 44 participants, actual
- Lead sponsor
- Debiopharm International SA
- Conditions
- Central Precocious Puberty
- Interventions
- Triptorelin
- First posted
- 2011-11-09
- Last updated
- 2017-07-28
- Results first posted
- 2015-09-04
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 Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6 | Month 6 | This is a lab test to see what percentage of participants were returned to normal before-puberty levels at Month 6. |
| Secondary | Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12 | at Months 1, 2, 3, 9 and 12 | This is a lab test to see what percentage of children were returned to normal before-puberty levels by the drug at each time point. |
| Secondary | Percentage of Children Maintaining LH Suppression at Prepubertal Levels 30 Minutes After Leuprolide Stimulation From Month 6 to 12 | from Month 6 to 12 | This is a lab test to see what percentage of children stayed at the normal before-puberty level from month 6 to month 12. |
| Secondary | Percentage of Children With LH Suppression (LH ≤ 4 IU/L)30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 6, 9 and 12 | at Months 1, 2, 3, 6, 9 and 12 | This is a lab test to see what percentage of children were returned to lower than normal before-puberty levels by the drug at each time point. |
| Secondary | Percentage of Children Maintaining LH Suppression at </= 4 IU/L 30 Minutes After Leuprolide Stimulation From Month 6 to 12 | from Month 6 to 12 | This is a lab test to see what percentage of children stayed at the lower than normal before-puberty level from month 6 to month 12. |
| Secondary | Change From Baseline in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) at Months 1, 2, 3, 6, 9, and 12 | Baseline to Months 1, 2, 3, 6, 9, and 12 | |
| Secondary | Change From Baseline in Estradiol Levels at Months 1, 2, 3, 6, 9, and 12 | Baseline to Months 1, 2, 3, 6, 9, and 12 | |
| Secondary | Change From Baseline in Testosterone Levels at Months 1, 2, 3, 6, 9, and 12 | Baseline to Months 1, 2, 3, 6, 9, and 12 | |
| Secondary | Percentage of Children With Prepubertal Estradiol or Testosterone Levels at Months 1, 2, 3, 6, 9, and 12 | at Months 1, 2, 3, 6, 9, and 12 | |
| Secondary | Percentage of Children Without Higher Basal LH and Estradiol or Testosterone | at 2 days after second triptorelin injection (Day 171) |
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 Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6 | Month 6 | Intention to treat, defined as all participants enrolled | percentage of participants | NUMBER |
| SECONDARY | Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12 | at Months 1, 2, 3, 9 and 12 | Intention to treat, defined as all participants enrolled | percentage of participants | NUMBER |
| SECONDARY | Percentage of Children Maintaining LH Suppression at Prepubertal Levels 30 Minutes After Leuprolide Stimulation From Month 6 to 12 | from Month 6 to 12 | Intention to treat, defined as all participants enrolled | percentage of participants | NUMBER |
| SECONDARY | Percentage of Children With LH Suppression (LH ≤ 4 IU/L)30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 6, 9 and 12 | at Months 1, 2, 3, 6, 9 and 12 | Intention to treat, defined as all participants enrolled | percentage of participants | NUMBER |
| SECONDARY | Percentage of Children Maintaining LH Suppression at </= 4 IU/L 30 Minutes After Leuprolide Stimulation From Month 6 to 12 | from Month 6 to 12 | Intention to treat, defined as all participants enrolled | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) at Months 1, 2, 3, 6, 9, and 12 | Baseline to Months 1, 2, 3, 6, 9, and 12 | Intention to treat, defined as all participants enrolled | IU/L | MEAN |
| SECONDARY | Change From Baseline in Estradiol Levels at Months 1, 2, 3, 6, 9, and 12 | Baseline to Months 1, 2, 3, 6, 9, and 12 | Intention to treat girls, defined as all girls enrolled | ng/L | MEAN |
| SECONDARY | Change From Baseline in Testosterone Levels at Months 1, 2, 3, 6, 9, and 12 | Baseline to Months 1, 2, 3, 6, 9, and 12 | Intention to treat boys, defined as all boys enrolled | ng/dL | MEAN |
| SECONDARY | Percentage of Children With Prepubertal Estradiol or Testosterone Levels at Months 1, 2, 3, 6, 9, and 12 | at Months 1, 2, 3, 6, 9, and 12 | Intention to treat, defined as all participants enrolled | percentage of participants | NUMBER |
| SECONDARY | Percentage of Children Without Higher Basal LH and Estradiol or Testosterone | at 2 days after second triptorelin injection (Day 171) | AOC Subset is defined as 50% of the population randomly assigned | percentage of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group71
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 Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6 | Children | 93.18 | 95% Confidence Interval 81.34 to 98.57 | percentage of participants | |
| Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12 | Children | Month 1 | 95.45 | percentage of participants | |
| Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12 | Children | Month 2 | 95.45 | percentage of participants | |
| Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12 | Children | Month 3 | 95.45 | percentage of participants | |
| Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12 | Children | Month 9 | 95.45 | percentage of participants | |
| Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12 | Children | Month 12 | 97.73 | percentage of participants | |
| Percentage of Children Maintaining LH Suppression at Prepubertal Levels 30 Minutes After Leuprolide Stimulation From Month 6 to 12 | Children | 93.18 | percentage of participants | ||
| Percentage of Children With LH Suppression (LH ≤ 4 IU/L)30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 6, 9 and 12 | Children | Month 1 | 95.45 | percentage of participants | |
| Percentage of Children With LH Suppression (LH ≤ 4 IU/L)30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 6, 9 and 12 | Children | Month 2 | 95.45 | percentage of participants | |
| Percentage of Children With LH Suppression (LH ≤ 4 IU/L)30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 6, 9 and 12 | Children | Month 3 | 93.18 | percentage of participants |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Children | 44 | |
| Overall Study | COMPLETED | Children | 44 | |
| Overall Study | NOT COMPLETED | Children | 0 |
Source ClinicalTrials.gov
Adverse events6
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 | Cough | Respiratory, thoracic and mediastinal disorders | Children | 3 | 44 | 4 |
| other | Headache | Nervous system disorders | Children | 6 | 44 | 7 |
| other | Gastroenteritis | Infections and infestations | Children | 3 | 44 | 3 |
| other | Nasopharyngitis | Infections and infestations | Children | 6 | 44 | 6 |
| other | Upper respiratory tract infection | Infections and infestations | Children | 4 | 44 | 5 |
| serious | Device related infection | Infections and infestations | Children | 1 | 44 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Children | ||
| Total, other adverse events | Children | 20 | 44 |
| Total, serious adverse events | Children | 1 | 44 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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/NCT01467882
GET https://conductscience.org/api/trials/v1/NCT01467882/results?page=2