Trial · NCT00355030
Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature
NCT00355030, Phase 3, Completed, Eli Lilly and Company; results first posted 2016-10-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature. Trials, record NCT00355030. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00355030
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature
- NCT number
- NCT00355030
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 91 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Idiopathic Short Stature (ISS)
- Interventions
- somatropin, leuprorelin
- First posted
- 2006-07-20
- Last updated
- 2019-09-30
- Results first posted
- 2016-10-18
- Limitations and caveats
- No statistical analyses was performed after the early treatment termination. All data represented is descriptive statistics only and no confirmatory conclusions can be drawn from this study.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With One or More Drug-related Adverse Events | Baseline through End of Study (up to 9 years) | A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
| Primary | Adult Height Standard Deviation Score (SDS) | Baseline through End of Study (up to 9 years) | The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height. |
| Secondary | Height Velocity | Baseline through End of Study (up to 9 years) | Height velocity is the difference between 2 height measurements, divided by years elapsed between measurements. |
| Secondary | Height SDS | Baseline through End of Study (up to 9 years) | SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height. |
| Secondary | Difference Between Adult Height SDS and Target Height SDS | Baseline through End of Study (up to 9 years) | This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of target height \[calculated as (mother's height (SDS) + father's height (SDS))/2\] for particular participant. The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height. |
| Secondary | Difference Between Adult Height SDS and Baseline Predicted Height SDS | Baseline through End up Study (up to 9 years) | This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline predicted height \[calculated using the Bayley-Pinneau method based on height and bone age\] for particular participant. The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height. |
| Secondary | Difference Between Adult Height SDS and Baseline Height SDS | Baseline through End up Study (up to 9 years) | This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline height for particular participant. The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height. |
| Secondary | Percentage of Children With Normal Adult Height SDS | Baseline through End of Study (up to 9 years) | Percentage of children with normal adult height SDS (greater than -2 SDS and less than +2 SDS) |
| Secondary | Bone Age | Baseline through End of Study (up to 9 years) | Bone age measured using the X-Ray of left hand and wrist. |
Source ClinicalTrials.gov
Outcomes9
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 One or More Drug-related Adverse Events | Baseline through End of Study (up to 9 years) | All participants who received at least one dose of study drug in Period 1 and all participants who entered Period 2 (safety population). | participants | NUMBER |
| PRIMARY | Adult Height Standard Deviation Score (SDS) | Baseline through End of Study (up to 9 years) | All participants who received at least one dose of study drug with at least one follow up visit. | standard deviation score | MEAN |
| SECONDARY | Height Velocity | Baseline through End of Study (up to 9 years) | All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1. | centimeter per year | MEAN |
| SECONDARY | Height SDS | Baseline through End of Study (up to 9 years) | All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1. | standard deviation score | MEAN |
| SECONDARY | Difference Between Adult Height SDS and Target Height SDS | Baseline through End of Study (up to 9 years) | All participants who received who reached final height. | standard deviation score | MEAN |
| SECONDARY | Difference Between Adult Height SDS and Baseline Predicted Height SDS | Baseline through End up Study (up to 9 years) | All participants who received who reached final height. | standard deviation score | MEAN |
| SECONDARY | Difference Between Adult Height SDS and Baseline Height SDS | Baseline through End up Study (up to 9 years) | All participants who received who reached final height. | standard deviation score | MEAN |
| SECONDARY | Percentage of Children With Normal Adult Height SDS | Baseline through End of Study (up to 9 years) | All participants who received at least one dose of study drug with at least one follow up visit. | percentage of participants | NUMBER |
| SECONDARY | Bone Age | Baseline through End of Study (up to 9 years) | All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1. | years | MEAN |
Source ClinicalTrials.gov
Results by group112
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 One or More Drug-related Adverse Events | Somatropin and Leuprorelin | Study Period 1 (n=46, 45) | 42 | participants | |
| Number of Participants With One or More Drug-related Adverse Events | Somatropin | Study Period 1 (n=46, 45) | 38 | participants | |
| Number of Participants With One or More Drug-related Adverse Events | Somatropin and Leuprorelin | Study Period 2 (n=20, 19) | 11 | participants | |
| Number of Participants With One or More Drug-related Adverse Events | Somatropin | Study Period 2 (n=20, 19) | 9 | participants | |
| Adult Height Standard Deviation Score (SDS) | Somatropin and Leuprorelin | -1.8 | Standard Deviation 0.53 | standard deviation score | |
| Adult Height Standard Deviation Score (SDS) | Somatropin | -1.9 | Standard Deviation 0.77 | standard deviation score | |
| Height Velocity | Somatropin and Leuprorelin | Randomization (n=45, 43) | 7.8 | Standard Deviation 6.92 | centimeter per year |
| Height Velocity | Somatropin | Randomization (n=45, 43) | 7.4 | Standard Deviation 6.03 | centimeter per year |
| Height Velocity | Somatropin and Leuprorelin | Month 3 (n=45, 43) | 9.9 | Standard Deviation 3.94 | centimeter per year |
| Height Velocity | Somatropin | Month 3 (n=45, 43) | 10.6 | Standard Deviation 3.53 | centimeter per year |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Study Period 1 Treatment | STARTED | Somatropin and Leuprorelin: Experimental Arm 1 | 46 | |
| Study Period 1 Treatment | STARTED | Somatropin: Experimental Arm 2 | 45 | |
| Study Period 1 Treatment | Received At Least One Dose of Study Drug | Somatropin and Leuprorelin: Experimental Arm 1 | 45 | |
| Study Period 1 Treatment | Received At Least One Dose of Study Drug | Somatropin: Experimental Arm 2 | 43 | |
| Study Period 1 Treatment | COMPLETED | Somatropin and Leuprorelin: Experimental Arm 1 | 1 | |
| Study Period 1 Treatment | COMPLETED | Somatropin: Experimental Arm 2 | 1 | |
| Study Period 1 Treatment | NOT COMPLETED | Somatropin and Leuprorelin: Experimental Arm 1 | 45 | |
| Study Period 1 Treatment | NOT COMPLETED | Somatropin: Experimental Arm 2 | 44 | |
| Study Period 2 Long Term Follow-Up | STARTED | Somatropin and Leuprorelin: Experimental Arm 1 | 20 | |
| Study Period 2 Long Term Follow-Up | STARTED | Somatropin: Experimental Arm 2 | 19 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events106
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 | Ear pain | Ear and labyrinth disorders | Somatropin and Leuprorelin | 1 | 46 | 5 |
| other | Ear pain | Ear and labyrinth disorders | Somatropin | 3 | 45 | 4 |
| other | Hypothyroidism | Endocrine disorders | Somatropin and Leuprorelin | 1 | 46 | 1 |
| other | Hypothyroidism | Endocrine disorders | Somatropin | 3 | 45 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Somatropin and Leuprorelin | 4 | 46 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Somatropin | 7 | 45 | 18 |
| other | Abdominal pain upper | Gastrointestinal disorders | Somatropin and Leuprorelin | 3 | 46 | 11 |
| other | Abdominal pain upper | Gastrointestinal disorders | Somatropin | 4 | 45 | 10 |
| other | Diarrhoea | Gastrointestinal disorders | Somatropin and Leuprorelin | 3 | 46 | 14 |
| other | Diarrhoea | Gastrointestinal disorders | Somatropin | 3 | 45 | 3 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Somatropin and Leuprorelin | ||
| Total, all-cause mortality | Somatropin | ||
| Total, other adverse events | Somatropin and Leuprorelin | 41 | 46 |
| Total, other adverse events | Somatropin | 36 | 45 |
| Total, serious adverse events | Somatropin and Leuprorelin | 12 | 46 |
| Total, serious adverse events | Somatropin | 7 | 45 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Somatropin and Leuprorelin vs Somatropin: serious adverse events |
Source Trial comparisons
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/NCT00355030
GET https://conductscience.org/api/trials/v1/NCT00355030/results?page=2