Trial · NCT00191113
Somatropin Treatment to Final Height in Turner Syndrome
NCT00191113, Phase 3, Completed, Eli Lilly and Company; results first posted 2010-01-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Somatropin Treatment to Final Height in Turner Syndrome. Trials, record NCT00191113. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00191113
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Somatropin Treatment to Final Height in Turner Syndrome
- NCT number
- NCT00191113
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 154 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Turner Syndrome
- Interventions
- Somatropin, Ethinyl estradiol, Medroxyprogesterone acetate
- First posted
- 2005-09-19
- Last updated
- 2010-01-27
- Results first posted
- 2010-01-27
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population | Baseline, and end of 4-year addendum | Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height. |
| Primary | Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height | at completion of core study, or at end of 4-year addendum | 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 \[NCHS\] uses the NCHS US general female population reference height values for age (Kuczmarski RJ et al. 2000) as the population mean and standard deviation. Calculation of Height SDS is provided in Height SDS \[Lyon\] description (Baseline). Since data reported by Kuczmarski RJ et al provides US general female population standards, values of Height SDS \[NCHS\] for untreated patients with Turner syndrome tend to be below zero e.g, -2.0 to -4.0 SDS. |
| Secondary | Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population | every 3 months during core study, and at start and end of 4-year addendum | Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height. |
| Secondary | Height (Centimeters [cm]) | every 3 months during core study, and at start and end of 4-year addendum | Most mature measurement available, at or after attainment of Final Height. |
| Secondary | Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment | at completion of core study or beginning of addendum | |
| Secondary | Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment | at completion of core study or beginning of addendum | |
| Secondary | Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment | at completion of core study or beginning of addendum | |
| Secondary | Number of Participants With Hearing Loss, Audiologist Assessment | at completion of core study or beginning of addendum | Sensorineural Hearing Loss (SNHL)=air conduction threshold \>20 dB HL and air-bone gap ≤10 dB HL; Conductive Hearing Loss (CHL)= air conduction threshold \>20 dB HL, bone conduction threshold ≤20 dB HL and air-bone gap \>10 dB HL; Mixed Hearing Loss (MHL) = evidence of SNHL as defined above and CHL as defined above, in the same ear; Unspecified Hearing Loss (UHL)= abnormal hearing with none of SNHL, CHL, or MHL present. |
| Secondary | Fasting Glucose, Change From Baseline | At core study baseline, and at end of 4-year addendum | Change from core study baseline to addendum 2 maximum. |
| Secondary | Maximum Fasting Glucose Value | At start and through end of 4-year addendum (up to an additional 2 years) | Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population | Baseline, and end of 4-year addendum | Population of all randomized patients. Intent to treat analysis with as-randomized treatment groups, at most mature measurement available. | Standard Deviation Score (SDS) [NCHS] | LEAST_SQUARES_MEAN |
| PRIMARY | Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height | at completion of core study, or at end of 4-year addendum | Population of patients for whom Final Height measurements are available. Efficacy analysis with as-treated treatment groups, at most mature measurement available at or after attainment of Final Height. | Standard Deviation Score (SDS) [NCHS] | LEAST_SQUARES_MEAN |
| SECONDARY | Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population | every 3 months during core study, and at start and end of 4-year addendum | Standard Deviation Score (SDS) [NCHS] | LEAST_SQUARES_MEAN | |
| SECONDARY | Height (Centimeters [cm]) | every 3 months during core study, and at start and end of 4-year addendum | centimeters (cm) | LEAST_SQUARES_MEAN | |
| SECONDARY | Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment | at completion of core study or beginning of addendum | All Randomized Patients with Hearing Examination | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment | at completion of core study or beginning of addendum | All Randomized Patients with Hearing Examination | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment | at completion of core study or beginning of addendum | All Randomized Patients with Hearing Examination | participants | NUMBER |
| SECONDARY | Number of Participants With Hearing Loss, Audiologist Assessment | at completion of core study or beginning of addendum | All Randomized Patients with Hearing Examination for whom Audiologist responded to Hearing Loss question | participants | NUMBER |
| SECONDARY | Fasting Glucose, Change From Baseline | At core study baseline, and at end of 4-year addendum | Patients who were followed for at least 4 years without growth hormone treatment or who received growth hormone for at least 4 years, and who were treated as randomized and had core study baseline and addendum glucose metabolism data. | mg / dL | LEAST_SQUARES_MEAN |
| SECONDARY | Maximum Fasting Glucose Value | At start and through end of 4-year addendum (up to an additional 2 years) | Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years. | milligrams per deciliter (mg/dL) | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population | As-Randomized Control | 0.09 | Standard Error 0.07 | Standard Deviation Score (SDS) [NCHS] | |
| Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population | As-Randomized Humatrope | 0.97 | Standard Error 0.07 | Standard Deviation Score (SDS) [NCHS] | |
| Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height | As-Treated No Growth Hormone | -3.30 | Standard Error 0.07 | Standard Deviation Score (SDS) [NCHS] | |
| Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height | As-Treated Growth Hormone | -2.25 | Standard Error 0.05 | Standard Deviation Score (SDS) [NCHS] | |
| Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population | As-Treated No Growth Hormone | -0.09 | Standard Error 0.08 | Standard Deviation Score (SDS) [NCHS] | |
| Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population | As-Treated Growth Humatrope | 0.99 | Standard Error 0.06 | Standard Deviation Score (SDS) [NCHS] | |
| Height (Centimeters [cm]) | As-Treated No Growth Hormone | 141.63 | Standard Error 0.47 | centimeters (cm) | |
| Height (Centimeters [cm]) | As-Treated Growth Humatrope | 148.52 | Standard Error 0.36 | centimeters (cm) | |
| Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment | As-Treated No Growth Hormone | 10 | participants | ||
| Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment | As-Treated Growth Hormone | 29 | participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Study | STARTED | As-Randomized Control | 78 | |
| Core Study | STARTED | As-Randomized Humatrope | 76 | |
| Core Study | COMPLETED | As-Randomized Control | 43 | |
| Core Study | COMPLETED | As-Randomized Humatrope | 61 | |
| Core Study | NOT COMPLETED | As-Randomized Control | 35 | |
| Core Study | NOT COMPLETED | As-Randomized Humatrope | 15 | |
| Addendum 1 | STARTED | As-Randomized Control | 2 | |
| Addendum 1 | STARTED | As-Randomized Humatrope | 0 | |
| Addendum 1 | COMPLETED | As-Randomized Control | 2 | |
| Addendum 1 | COMPLETED | As-Randomized Humatrope | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events262
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 ache | Ear and labyrinth disorders | Treated-As-Randomized Control | 6 | 54 | |
| other | Ear ache | Ear and labyrinth disorders | Treated-As-Randomized Humatrope | 10 | 74 | |
| other | Ear discharge | Ear and labyrinth disorders | Treated-As-Randomized Control | 0 | 54 | |
| other | Ear discharge | Ear and labyrinth disorders | Treated-As-Randomized Humatrope | 4 | 74 | |
| other | Ear pain | Ear and labyrinth disorders | Treated-As-Randomized Control | 3 | 54 | |
| other | Ear pain | Ear and labyrinth disorders | Treated-As-Randomized Humatrope | 14 | 74 | |
| other | Earache | Ear and labyrinth disorders | Treated-As-Randomized Control | 5 | 54 | |
| other | Earache | Ear and labyrinth disorders | Treated-As-Randomized Humatrope | 8 | 74 | |
| other | Hearing loss | Ear and labyrinth disorders | Treated-As-Randomized Control | 2 | 54 | |
| other | Hearing loss | Ear and labyrinth disorders | Treated-As-Randomized Humatrope | 7 | 74 |
1 to 10 of 262Source ClinicalTrials.gov
See all 262 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treated-As-Randomized Control | ||
| Total, all-cause mortality | Treated-As-Randomized Humatrope | ||
| Total, other adverse events | Treated-As-Randomized Control | 53 | 54 |
| Total, other adverse events | Treated-As-Randomized Humatrope | 74 | 74 |
| Total, serious adverse events | Treated-As-Randomized Control | 10 | 54 |
| Total, serious adverse events | Treated-As-Randomized Humatrope | 22 | 74 |
Source ClinicalTrials.gov
Papers5
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| As-Treated No Growth Hormone vs As-Treated Growth Humatrope: Number of Participants With Any Abnormal Fasting Glucose Value | Trial comparisons |
| As-Treated No Growth Hormone vs As-Treated Growth Hormone: Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment | Trial comparisons |
| As-Treated No Growth Hormone vs As-Treated Growth Hormone: Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value | Trial comparisons |
| As-Treated No Growth Hormone vs As-Treated Growth Humatrope: Number of Participants With Any Abnormal Fasting Insulin Value | Trial comparisons |
| As-Treated No Growth Hormone vs As-Treated Growth Hormone: Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment | Trial comparisons |
| As-Treated No Growth Hormone vs As-Treated Growth Hormone: Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value | Trial comparisons |
| As-Treated No Growth Hormone vs As-Treated Growth Hormone: Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment | Trial comparisons |
| Treated-As-Randomized Control vs Treated-As-Randomized Humatrope: serious adverse events | 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/NCT00191113
GET https://conductscience.org/api/trials/v1/NCT00191113/results?page=2