Trial · NCT00667446
Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty
NCT00667446, Phase 3, Completed, AbbVie (prior sponsor, Abbott); results first posted 2013-12-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty. Trials, record NCT00667446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00667446
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty
- NCT number
- NCT00667446
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 72 participants, actual
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Conditions
Precocious, Leuprolide Acetate, Luteinizing Hormone (LH), Gonadotrophin-releasing Hormone Agonist (GnRHa), Tanner Staging, Depot Formulation, Suppression of LH, Central Precocious Puberty (CPP), Gonadotrophin-releasing Hormone (GnRH), Lupron, GnRH Analog, Pediatrics Central Precocious Puberty
- Interventions
- Leuprolide Acetate 3 Month Depot
- First posted
- 2008-04-28
- Last updated
- 2014-01-09
- Results first posted
- 2013-12-10
Source ClinicalTrials.gov
Registered outcomes9
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 | Day 1, Months 6, 12, 24, and 36 | Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH \< 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36. |
| Secondary | Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1) | Day 1, Months 3, 6, 9, 12, and 24 | The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol \< 20 pg/mL. The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed before this change occurred, with an LLOQ of 1 pg/mL. Final visit is the participant's last visit closest to Month 36. |
| Secondary | Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2) | Months 6, 9, 12, 24, 30, and 36 | The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol \< 20 pg/mL. The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed after this change occurred, with an LLOQ of 10 pg/mL. Final visit is the participant's last visit closest to Month 36. |
| Secondary | Percentage of Male Participants With Suppression of Basal Testosterone | Day 1, Months 3, 6, 9, 12, 24, 30, and 36 | The percentage of male participants with suppression of basal testosterone to prepubertal levels, defined as testosterone \< 30 ng/dL. Final visit is the participant's last visit closest to Month 36. |
| Secondary | Mean Peak-stimulated Luteinizing Hormone Concentration by Visit | Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36 | Peak-stimulated luteinizing hormone refers to the maximum luteinizing hormone concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Final visit is the participant's last visit closest to Month 36. |
| Secondary | Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development) | Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 | The percentage of female participants with suppression of breast development. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression of breast development is defined as regression or no progression of breast development from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36. |
| Secondary | Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) | Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 | The percentage of male participants with suppression of testicular volume and genital staging. Testicular volume was calculated from the length, width and height of each testicle measured by ultrasound. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression is defined as regression or no progression in both testicular volume and genital staging from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36. |
| Secondary | Change From Baseline in Growth Rate | Baseline (the 1 year prior to the start of treatment in the lead-in study), and Day 1, Months 6, 12, 18, 24, 30, and 36 | Baseline growth rate was the growth rate in the one year prior to Day 1 of the lead-in study L-CP07-167. Growth rates were calculated as the ratio of the change in height to the change in chronological age with an approximate 6-month interval for Day 1, Months 6, 12, 18, 24, 30, 36 and the Final Treatment Visit. |
| Secondary | Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age | Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36 | Bone age was determined by left hand/wrist bone age radiographs that were evaluated using the Fels Method by a central reader. The ratio of change from Baseline in bone age (BA)/change from Baseline in chronological age (CA) was calculated using the following formula: (BA at Post-baseline Treatment Visit - BA at Baseline) / (CA at Post-baseline Treatment Visit - CA at Baseline). |
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 | Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone | Day 1, Months 6, 12, 24, and 36 | Intention-to-treat, defined as patients who received at least 1 dose of study drug with at least 1 post-baseline measurement of any maintenance of suppression variable, \& did not prematurely discontinue in the 1st 30 days due to inadequate suppression at Month 6 of the lead-in study. N= the number of patients with available data at each time point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1) | Day 1, Months 3, 6, 9, 12, and 24 | Intention-to-treat female population. N = the number of participants with available data at each time point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2) | Months 6, 9, 12, 24, 30, and 36 | Intention-to-treat female population. N = the number of participants with available data at each time point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Male Participants With Suppression of Basal Testosterone | Day 1, Months 3, 6, 9, 12, 24, 30, and 36 | Intention-to-treat male population. N = the number of participants with available data at each time point. | percentage of participants | NUMBER |
| SECONDARY | Mean Peak-stimulated Luteinizing Hormone Concentration by Visit | Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36 | Intention-to-treat. N = the number of participants with available data at each time point. | mIU/mL | MEAN |
| SECONDARY | Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development) | Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 | Intention-to-treat female population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) | Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 | Intention-to-treat male population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Growth Rate | Baseline (the 1 year prior to the start of treatment in the lead-in study), and Day 1, Months 6, 12, 18, 24, 30, and 36 | Intention-to-treat with available growth rate data. N = participants with available data at each time point. | cm/year | MEAN |
| SECONDARY | Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age | Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36 | Intention-to-treat with available bone age data. N = participants with available data at each time point. | ratio | MEAN |
Source ClinicalTrials.gov
Results by group140
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 | Leuprolide Acetate 3M Depot 11.25 mg | Day 1 [N= 32, 37] | 96.9 | 95% Confidence Interval 83.78 to 99.92 | percentage of participants |
| Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone | Leuprolide Acetate 3M Depot 30 mg | Day 1 [N= 32, 37] | 100.0 | 95% Confidence Interval 90.51 to 100.00 | percentage of participants |
| Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone | Leuprolide Acetate 3M Depot 11.25 mg | Month 6 [N=32, 36] | 93.8 | 95% Confidence Interval 79.19 to 99.23 | percentage of participants |
| Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone | Leuprolide Acetate 3M Depot 30 mg | Month 6 [N=32, 36] | 100.0 | 95% Confidence Interval 90.26 to 100.00 | percentage of participants |
| Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone | Leuprolide Acetate 3M Depot 11.25 mg | Month 12 [N=31, 32] | 90.3 | 95% Confidence Interval 74.25 to 97.96 | percentage of participants |
| Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone | Leuprolide Acetate 3M Depot 30 mg | Month 12 [N=31, 32] | 96.9 | 95% Confidence Interval 83.78 to 99.92 | percentage of participants |
| Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone | Leuprolide Acetate 3M Depot 11.25 mg | Month 24 [N=16, 18] | 87.5 | 95% Confidence Interval 64.65 to 98.45 | percentage of participants |
| Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone | Leuprolide Acetate 3M Depot 30 mg | Month 24 [N=16, 18] | 100.0 | 95% Confidence Interval 81.47 to 100.00 | percentage of participants |
| Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone | Leuprolide Acetate 3M Depot 11.25 mg | Month 36 [N=9, 11] | 77.8 | 95% Confidence Interval 39.99 to 97.19 | percentage of participants |
| Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone | Leuprolide Acetate 3M Depot 30 mg | Month 36 [N=9, 11] | 100.0 | 95% Confidence Interval 71.51 to 100.00 | percentage of participants |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period (36 Months) | STARTED | Leuprolide Acetate 3M Depot 11.25 mg | 34 | |
| Treatment Period (36 Months) | STARTED | Leuprolide Acetate 3M Depot 30 mg | 38 | |
| Treatment Period (36 Months) | COMPLETED | Leuprolide Acetate 3M Depot 11.25 mg | 11 | |
| Treatment Period (36 Months) | COMPLETED | Leuprolide Acetate 3M Depot 30 mg | 13 | |
| Treatment Period (36 Months) | NOT COMPLETED | Leuprolide Acetate 3M Depot 11.25 mg | 23 | |
| Treatment Period (36 Months) | NOT COMPLETED | Leuprolide Acetate 3M Depot 30 mg | 25 | |
| Safety Follow-up Period (12 Weeks) | STARTED | Leuprolide Acetate 3M Depot 11.25 mg | 28 | |
| Safety Follow-up Period (12 Weeks) | STARTED | Leuprolide Acetate 3M Depot 30 mg | 26 | |
| Safety Follow-up Period (12 Weeks) | COMPLETED | Leuprolide Acetate 3M Depot 11.25 mg | 28 | |
| Safety Follow-up Period (12 Weeks) | COMPLETED | Leuprolide Acetate 3M Depot 30 mg | 25 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events72
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 | Leuprolide Acetate 3M Depot 11.25 mg | 1 | 34 | |
| other | EAR PAIN | Ear and labyrinth disorders | Leuprolide Acetate 3M Depot 30 mg | 2 | 38 | |
| other | MYOPIA | Eye disorders | Leuprolide Acetate 3M Depot 11.25 mg | 0 | 34 | |
| other | MYOPIA | Eye disorders | Leuprolide Acetate 3M Depot 30 mg | 2 | 38 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Leuprolide Acetate 3M Depot 11.25 mg | 2 | 34 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Leuprolide Acetate 3M Depot 30 mg | 3 | 38 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Leuprolide Acetate 3M Depot 11.25 mg | 2 | 34 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Leuprolide Acetate 3M Depot 30 mg | 3 | 38 | |
| other | CONSTIPATION | Gastrointestinal disorders | Leuprolide Acetate 3M Depot 11.25 mg | 2 | 34 | |
| other | CONSTIPATION | Gastrointestinal disorders | Leuprolide Acetate 3M Depot 30 mg | 1 | 38 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Leuprolide Acetate 3M Depot 11.25 mg | ||
| Total, all-cause mortality | Leuprolide Acetate 3M Depot 30 mg | ||
| Total, other adverse events | Leuprolide Acetate 3M Depot 11.25 mg | 31 | 34 |
| Total, other adverse events | Leuprolide Acetate 3M Depot 30 mg | 31 | 38 |
| Total, serious adverse events | Leuprolide Acetate 3M Depot 11.25 mg | 1 | 34 |
| Total, serious adverse events | Leuprolide Acetate 3M Depot 30 mg | 0 | 38 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24926950 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Leuprolide Acetate 3M Depot 11.25 mg vs Leuprolide Acetate 3M Depot 30 mg: 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/NCT00667446
GET https://conductscience.org/api/trials/v1/NCT00667446/results?page=2