Trial · NCT02452931
Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
NCT02452931, Phase 3, Completed, Tolmar Inc.; results first posted 2020-05-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty. Trials, record NCT02452931. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02452931
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
- NCT number
- NCT02452931
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 64 participants, actual
- Lead sponsor
- Tolmar Inc.
- Conditions
- Precocious Puberty, Central
- Interventions
- Leuprolide Acetate 45 mg
- First posted
- 2015-05-25
- Last updated
- 2020-06-02
- Results first posted
- 2020-05-20
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months. | 6 months | Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH \<4 IU/L. Peak stimulated LH refers to the maximum LH concentration measured 30 minutes after a gonadotropin-releasing hormone agonst (GnRHa) stimulation test. |
| Secondary | Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels. | Week 12, Week 24, Week 36, and Week 48 | Percentage of subjects with suppressed serum LH concentrations(\<4 IU/L) 30 minutes post GnRHa stimulation test at all assessed timepoints. |
| Secondary | Changes in Height Velocity (Growth Rate) | Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48 | Changes in height velocity (growth rate) at all study timepoints after Screening to end of study. Growth velocity is defined for each visit as change from baseline / \[(number of weeks since baseline)/52\]. Week 48: Change from Week 24 growth velocity is defined as change from week 24 to week 48 / \[(number of weeks since week 24)/52\]. |
| Secondary | Bone Age Ratio to Chronological Age at Time of Measurement | Week 24 and Week 48 | Bone Age Ratio to Chronological Age at Time of Measurement is bone age/age at bone age assessment. |
| Secondary | Percent Change From Baseline in Height | Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48 | The percent change from baseline in height at each available post-baseline measurement. Percent change is defined as (((change from Baseline)/(Baseline)) x 100). |
| Secondary | Tanner Scores: Boys - Development of External Genitalia | Baseline, Week 12, Week 24, Week 36, and Week 48 | Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics. |
| Secondary | Tanner Scores: Boys - Development of External Genitalia (Change From Baseline) | Week 12, Week 24, Week 36, and Week 48 | Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics. |
| Secondary | Tanner Scores: Boys and Girls - Pubic Hair | Baseline, Week 12, Week 24, Week 36, and Week 48 | Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics. |
| Secondary | Tanner Scores: Boys and Girls - Pubic Hair (Change From Baseline) | Week 12, Week 24, Week 36, and Week 48 | Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics. |
| Secondary | Tanner Scores: Girls - Breast Development | Baseline, Week 12, Week 24, Week 36, and Week 48 | Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
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 Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months. | 6 months | Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels. | Week 12, Week 24, Week 36, and Week 48 | Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Changes in Height Velocity (Growth Rate) | Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48 | Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing. | cm/year | MEAN |
| SECONDARY | Bone Age Ratio to Chronological Age at Time of Measurement | Week 24 and Week 48 | Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing. | Ratio | MEAN |
| SECONDARY | Percent Change From Baseline in Height | Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48 | Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing. | Percent change | MEAN |
| SECONDARY | Tanner Scores: Boys - Development of External Genitalia | Baseline, Week 12, Week 24, Week 36, and Week 48 | Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing. | Score on a scale | MEAN |
| SECONDARY | Tanner Scores: Boys - Development of External Genitalia (Change From Baseline) | Week 12, Week 24, Week 36, and Week 48 | Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing. | Score on a scale | MEAN |
| SECONDARY | Tanner Scores: Boys and Girls - Pubic Hair | Baseline, Week 12, Week 24, Week 36, and Week 48 | Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing. | Score on a scale | MEAN |
| SECONDARY | Tanner Scores: Boys and Girls - Pubic Hair (Change From Baseline) | Week 12, Week 24, Week 36, and Week 48 | Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing. | Score on a scale | MEAN |
| SECONDARY | Tanner Scores: Girls - Breast Development | Baseline, Week 12, Week 24, Week 36, and Week 48 | Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing. | Score on a scale | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group236
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 Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months. | Assigned Intervention | 54 | Participants | ||
| Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels. | Assigned Intervention | Visit 3, Week 12 | 51 | Participants | |
| Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels. | Assigned Intervention | Visit 5, Week 24 | 54 | Participants | |
| Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels. | Assigned Intervention | Visit 6, Week 36 | 50 | Participants | |
| Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels. | Assigned Intervention | End of Treatment, Week 48 | 50 | Participants | |
| Changes in Height Velocity (Growth Rate) | Assigned Intervention | Visit 2, Week 4 | 8.89 | Standard Deviation 13.128 | cm/year |
| Changes in Height Velocity (Growth Rate) | Assigned Intervention | Visit 3, Week 12 | 8.30 | Standard Deviation 4.782 | cm/year |
| Changes in Height Velocity (Growth Rate) | Assigned Intervention | Visit 4, Week 20 | 6.66 | Standard Deviation 3.155 | cm/year |
| Changes in Height Velocity (Growth Rate) | Assigned Intervention | Visit 5, Week 24 | 6.90 | Standard Deviation 3.074 | cm/year |
| Changes in Height Velocity (Growth Rate) | Assigned Intervention | Visit 6, Week 36 | 6.48 | Standard Deviation 2.272 | cm/year |
1 to 10 of 236Source ClinicalTrials.gov
See all 236 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Assigned Intervention | 64 | |
| Overall Study | COMPLETED | Assigned Intervention | 60 | |
| Overall Study | NOT COMPLETED | Assigned Intervention | 4 |
Source ClinicalTrials.gov
Adverse events13
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 | Assigned Intervention | 6 | 64 | |
| other | Nausea | Gastrointestinal disorders | Assigned Intervention | 5 | 64 | |
| other | Constipation | Gastrointestinal disorders | Assigned Intervention | 4 | 64 | |
| other | Vomiting | Gastrointestinal disorders | Assigned Intervention | 4 | 64 | |
| other | Pyrexia | General disorders | Assigned Intervention | 11 | 64 | |
| other | Nasopharyngitis | Infections and infestations | Assigned Intervention | 14 | 64 | |
| other | Upper respiratory tract infection | Infections and infestations | Assigned Intervention | 4 | 64 | |
| other | Headache | Nervous system disorders | Assigned Intervention | 10 | 64 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Assigned Intervention | 8 | 64 | |
| other | Bronchospasm | Respiratory, thoracic and mediastinal disorders | Assigned Intervention | 4 | 64 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Assigned Intervention | 0 | 64 |
| Total, other adverse events | Assigned Intervention | 55 | 64 |
| Total, serious adverse events | Assigned Intervention | 1 | 64 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32738042 | 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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02452931
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