Trial · NCT00635817
A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty
NCT00635817, Phase 3, Completed, Abbott; results first posted 2011-02-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty. Trials, record NCT00635817. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00635817
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty
- NCT number
- NCT00635817
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 84 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Puberty, Precocious
- Interventions
- Leuprolide acetate 11.25 mg, Leuprolide acetate 30 mg
- First posted
- 2008-03-14
- Last updated
- 2011-11-02
- Results first posted
- 2011-02-09
Source ClinicalTrials.gov
Registered outcomes8
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 (<4 mIU/mL) From Month 2 Through Month 6 | Month 2 through 6 | Percentage of participants with suppression of peak stimulated luteinizing hormone that was measured after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test at Month (Mo) 2, 3, and 6. The analysis was performed according to a life table method. Subjects who withdrew without peak-stimulated luteinizing hormone \>= 4 mIU/mL were censored at their last measurement of peak-stimulated luteinizing hormone. |
| Secondary | Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit | Month 1, 2, 3 and 6 | Percentage of participants with suppression of estradiol, out of the number of girls with at least 1 estradiol measurement at each visit (n/N%). Only girls are analyzed in this outcome measure. Observed data were used with no imputation for missing data. |
| Secondary | Percentage of Participants With Suppression of Testosterone in <30 ng/dL by Visit | Month 1, 2, 3 and 6 | Percentage of participants with suppression of testosterone, out of the number of boys with at least 1 testosterone measurement at each visit (n/N%). Only boys are analyzed in this outcome measure. Observed data were used with no imputation for missing data. |
| Secondary | Peak-stimulated Luteinizing Hormone Concentration by Visit | Baseline, Month 1, 2, 3 and 6 | Observed data were used with no imputation for missing data. |
| Secondary | Percentage of Participants With Suppression of the Physical Signs of Puberty (Breast Development) at Month 6 | Month 6 | Percentage of participants with suppression of breast development, out of the number of girls with pubertal staging of breast development (n/N%). Only girls are analyzed in this outcome measure. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a Tanner Staging pictogram. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Observed data were used with no imputation for missing data. |
| Secondary | Percentage of Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) at Month 6 | Month 6 | Percentage of participants with suppression of genital development and testicular volume, out of the number of boys with pubertal staging of genital development or testicular volume (n/N%). Only boys are analyzed in this outcome measure. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a Tanner Staging pictogram. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Observed data were used with no imputation for missing data. |
| Secondary | Change From Baseline in Incremental Growth Rate (cm/Year) at Month 6 | Baseline and Month 6 | The growth rate at baseline was the growth rate during the last year before the start of treatment and was calculated with the measurement closest to Day -336 (before Day -30) and the measurement up to Day 1. Growth rate at Month 6 was defined as the ratio of the change in height from Day 1 to the change in chronological age, with an approximate 6-month interval between the 2 height measurements. Observed data were used with no imputation for missing data. |
| Secondary | Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age at Month 6 | Baseline to Month 6 | The ratio at Month 6 was calculated as (bone age at Month 6 - bone age at baseline)/(chronological age at Month 6 - chronological age at baseline). Observed data were used with no imputation for missing data. Baseline bone-age radiograph was performed at or within 3 months of the Screening Visit. |
Source ClinicalTrials.gov
Outcomes10
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 (<4 mIU/mL) From Month 2 Through Month 6 | Month 2 through 6 | Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement of peak stimulated luteinizing hormone at Mo 2 or afterward defined as the intent-to-treat population. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit | Month 1, 2, 3 and 6 | Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Suppression of Testosterone in <30 ng/dL by Visit | Month 1, 2, 3 and 6 | Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population. | Percentage of Participants | NUMBER |
| SECONDARY | Peak-stimulated Luteinizing Hormone Concentration by Visit | Baseline, Month 1, 2, 3 and 6 | Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population. | mIU/mL | MEAN |
| SECONDARY | Percentage of Participants With Suppression of the Physical Signs of Puberty (Breast Development) at Month 6 | Month 6 | Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) at Month 6 | Month 6 | Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Incremental Growth Rate (cm/Year) at Month 6 | Baseline and Month 6 | Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population. | cm/year | MEAN |
| SECONDARY | Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age at Month 6 | Baseline to Month 6 | Participants must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population. | Ratio | MEAN |
| POST_HOC | Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (< 4 mIU/mL) From Month 2 Through Month 6 (Simple Percentage With Binomial Exact Confidence Intervals) | Month 2 through 6 | Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement of peak stimulated luteinizing hormone at Mo 2 or afterward defined as the intent-to-treat population. | Percentage of Participants | NUMBER |
| POST_HOC | Percentage of Participants With a Decrease From Baseline in the Ratio of Bone Age to Chronological Age at Month 6 Compared to Baseline | Baseline to Month 6 | The baseline time frame was increased from the secondary outcome to this analysis to include all participants with a bone age radiograph at screening. This analysis was performed post hoc to match the FDA package insert. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group82
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 (<4 mIU/mL) From Month 2 Through Month 6 | Leuprolide Acetate 11.25 mg - Treatment Naive | 76.2 | 95% Confidence Interval 9.29 | Percentage of Participants | |
| Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 6 | Leuprolide Acetate 11.25 mg - Previous Treatment | 80.7 | 95% Confidence Interval 8.69 | Percentage of Participants | |
| Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 6 | Leuprolide Acetate 30 mg - Treatment Naive | 90.5 | 95% Confidence Interval 6.41 | Percentage of Participants | |
| Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 6 | Leuprolide Acetate 30 mg - Previous Treatment | 100 | 95% Confidence Interval 0.00 | Percentage of Participants | |
| Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit | Leuprolide Acetate 11.25 mg - Treatment Naive | Mo 1 (Arm A N=17, B N=18, C N=19, D N=16) | 100 | 95% Confidence Interval 80.5 to 100 | Percentage of Participants |
| Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit | Leuprolide Acetate 11.25 mg - Previous Treatment | Mo 1 (Arm A N=17, B N=18, C N=19, D N=16) | 100 | 95% Confidence Interval 81.5 to 100 | Percentage of Participants |
| Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit | Leuprolide Acetate 30 mg - Treatment Naive | Mo 1 (Arm A N=17, B N=18, C N=19, D N=16) | 100 | 95% Confidence Interval 82.4 to 100 | Percentage of Participants |
| Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit | Leuprolide Acetate 30 mg - Previous Treatment | Mo 1 (Arm A N=17, B N=18, C N=19, D N=16) | 100 | 95% Confidence Interval 79.4 to 100 | Percentage of Participants |
| Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit | Leuprolide Acetate 11.25 mg - Treatment Naive | Mo 2 (Arm A N=19, B N=14, C N=19, D N=14) | 94.7 | 95% Confidence Interval 74.0 to 99.9 | Percentage of Participants |
| Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit | Leuprolide Acetate 11.25 mg - Previous Treatment | Mo 2 (Arm A N=19, B N=14, C N=19, D N=14) | 100 | 95% Confidence Interval 76.8 to 100 | Percentage of Participants |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Leuprolide Acetate 11.25 mg - Treatment Naive | 21 | |
| Overall Study | STARTED | Leuprolide Acetate 11.25 mg - Previous Treatment | 21 | |
| Overall Study | STARTED | Leuprolide Acetate 30 mg - Treatment Naive | 21 | |
| Overall Study | STARTED | Leuprolide Acetate 30 mg - Previous Treatment | 21 | |
| Overall Study | COMPLETED | Leuprolide Acetate 11.25 mg - Treatment Naive | 15 | |
| Overall Study | COMPLETED | Leuprolide Acetate 11.25 mg - Previous Treatment | 19 | |
| Overall Study | COMPLETED | Leuprolide Acetate 30 mg - Treatment Naive | 19 | |
| Overall Study | COMPLETED | Leuprolide Acetate 30 mg - Previous Treatment | 21 | |
| Overall Study | NOT COMPLETED | Leuprolide Acetate 11.25 mg - Treatment Naive | 6 | |
| Overall Study | NOT COMPLETED | Leuprolide Acetate 11.25 mg - Previous Treatment | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events112
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 | Lymphadenopathy | Blood and lymphatic system disorders | Leuprolide Acetate 11.25 mg - Treatment Naive | 1 | 21 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Leuprolide Acetate 11.25 mg - Previous Treatment | 1 | 21 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Leuprolide Acetate 30 mg - Treatment Naive | 0 | 21 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Leuprolide Acetate 30 mg - Previous Treatment | 2 | 21 | |
| other | Ear Pain | Ear and labyrinth disorders | Leuprolide Acetate 11.25 mg - Treatment Naive | 0 | 21 | |
| other | Ear Pain | Ear and labyrinth disorders | Leuprolide Acetate 11.25 mg - Previous Treatment | 1 | 21 | |
| other | Ear Pain | Ear and labyrinth disorders | Leuprolide Acetate 30 mg - Treatment Naive | 0 | 21 | |
| other | Ear Pain | Ear and labyrinth disorders | Leuprolide Acetate 30 mg - Previous Treatment | 2 | 21 | |
| other | Goiter | Endocrine disorders | Leuprolide Acetate 11.25 mg - Treatment Naive | 0 | 21 | |
| other | Goiter | Endocrine disorders | Leuprolide Acetate 11.25 mg - Previous Treatment | 0 | 21 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Leuprolide Acetate 11.25 mg - Treatment Naive | ||
| Total, all-cause mortality | Leuprolide Acetate 11.25 mg - Previous Treatment | ||
| Total, all-cause mortality | Leuprolide Acetate 30 mg - Treatment Naive | ||
| Total, all-cause mortality | Leuprolide Acetate 30 mg - Previous Treatment | ||
| Total, other adverse events | Leuprolide Acetate 11.25 mg - Treatment Naive | 13 | 21 |
| Total, other adverse events | Leuprolide Acetate 11.25 mg - Previous Treatment | 18 | 21 |
| Total, other adverse events | Leuprolide Acetate 30 mg - Treatment Naive | 15 | 21 |
| Total, other adverse events | Leuprolide Acetate 30 mg - Previous Treatment | 17 | 21 |
| Total, serious adverse events | Leuprolide Acetate 11.25 mg - Treatment Naive | 1 | 21 |
| Total, serious adverse events | Leuprolide Acetate 11.25 mg - Previous Treatment | 0 | 21 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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
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The record and each of its lists are JSON, twenty rows a page. No key.
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