Trial · NCT03695237
A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
NCT03695237, Phase 3, Completed, AbbVie; results first posted 2023-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP). Trials, record NCT03695237. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03695237
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
- NCT number
- NCT03695237
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 45 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Central Precocious Puberty (CPP)
- Interventions
- Leuprolide Acetate (LA)
- First posted
- 2018-10-04
- Last updated
- 2024-05-29
- Results first posted
- 2023-05-16
Source ClinicalTrials.gov
Registered outcomes10
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 Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24 | Week 24 (prior to the Week 24 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection. | Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg. Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test. Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL. |
| Secondary | Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Weeks 12, 20, 44, and 48 (prior to Week 48 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection. | Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg. Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test. Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL. |
| Secondary | Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Weeks 12, 20, 24, 44, and 48 | Estradiol concentrations were measured from blood samples taken at each study visit prior to stimulation testing (and prior to study drug administration at Weeks 24 and 48). |
| Secondary | Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Weeks 12, 20, 24, 44, and 48 | Testosterone concentrations were measured from blood samples taken at each study visit prior to stimulation testing (and prior to study drug administration for Weeks 24 and 48). |
| Secondary | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Part 1: Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144 | Breast development in females and testicular volume or genital development in males was assessed using modified Tanner staging, on a scale from Stage 1 (prepubertal) to Stage 5 (adult characteristics). Females: Suppression is defined as regression or no progression of breast development according to modified Tanner staging. Males: Suppression is defined as regression or no progression in testicular volume and genital staging according to modified Tanner staging. |
| Secondary | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Part 1: Baseline and Weeks 4, 12, 20, 24, 44, and 48; Part 2: Weeks 72, 96, 120, and 144 | Growth rate (height in centimeter/year) was calculated both prior to treatment in the study and during the study. For Baseline calculation a historical measurement of height at least 6 months prior to Screening and the Screening value was used. |
| Secondary | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Part 1: Baseline and Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144 | Bone age was assessed from radiographs of the hand and wrist by a central imaging vendor using the BoneXpert automated system. A ratio less than 1 indicates less advancement of bone age compared to chronological age. |
| Secondary | Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL) | Weeks 72, 96, 120, and 144 | Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg. Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test. Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL. |
| Secondary | Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL | Weeks 72, 96, 120, and 144 | Estradiol concentrations were measured from blood samples taken at each study visit prior to stimulation testing. |
| Secondary | Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL | Weeks 72, 96, 120, and 144 | Male participants with maintenance of suppression of testosterone to \< 30 ng/dL are assessed |
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 Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24 | Week 24 (prior to the Week 24 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection. | The Full Analysis Set (FAS) consists of all participants who received at least 1 dose of study drug. Participants with missing GnRHa-stimulated LH results at Week 24 were counted as not achieving suppression. | percentage of participants | NUMBER |
| SECONDARY | Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Weeks 12, 20, 44, and 48 (prior to Week 48 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection. | The Full Analysis Set (FAS) consists of all participants who received at least 1 dose of study drug. Participants with missing GnRHa-stimulated LH results at a specific visit were counted as not achieving suppression for that visit. | percentage of participants | NUMBER |
| SECONDARY | Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Weeks 12, 20, 24, 44, and 48 | Full analysis set; female participants with available data at each time point | percentage of participants | NUMBER |
| SECONDARY | Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Weeks 12, 20, 24, 44, and 48 | Full analysis set; male participants with available data at each time point | percentage of participants | NUMBER |
| SECONDARY | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Part 1: Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144 | Full analysis set; results for males and females (with an assessment at each time point) are reported separately. | percentage of participants | NUMBER |
| SECONDARY | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Part 1: Baseline and Weeks 4, 12, 20, 24, 44, and 48; Part 2: Weeks 72, 96, 120, and 144 | Full analysis set; participants with available data at Baseline (43 participants) and each time point. | cm/year | MEAN |
| SECONDARY | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Part 1: Baseline and Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144 | Full analysis set; based on non missing observations. | ratio | MEAN |
| SECONDARY | Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL) | Weeks 72, 96, 120, and 144 | Full analysis set; observed cases. | percentage of participants | NUMBER |
| SECONDARY | Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL | Weeks 72, 96, 120, and 144 | Full analysis set; participants with non-missing observations. | percentage of participants | NUMBER |
| SECONDARY | Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL | Weeks 72, 96, 120, and 144 | Full analysis set; participants with non-missing observations. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group165
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 Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24 | Leuprolide Acetate - Previously Treated | 94.4 | 95% Confidence Interval 72.7 to 99.9 | percentage of participants | |
| Percentage of Participants With Suppression of Peak Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24 | Leuprolide Acetate - Treament Naïve | 81.5 | 95% Confidence Interval 61.9 to 93.7 | percentage of participants | |
| Percentage of Participants With Suppression of Peak Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24 | Leuprolide Acetate - Overall | 86.7 | 95% Confidence Interval 73.2 to 95.0 | percentage of participants | |
| Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Leuprolide Acetate - Previously Treated | Week 12 | 83.3 | 95% Confidence Interval 58.6 to 96.4 | percentage of participants |
| Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Leuprolide Acetate - Treament Naïve | Week 12 | 88.9 | 95% Confidence Interval 70.8 to 97.7 | percentage of participants |
| Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Leuprolide Acetate - Overall | Week 12 | 86.7 | 95% Confidence Interval 73.2 to 95.0 | percentage of participants |
| Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Leuprolide Acetate - Previously Treated | Week 20 | 94.4 | 95% Confidence Interval 72.7 to 99.9 | percentage of participants |
| Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Leuprolide Acetate - Treament Naïve | Week 20 | 85.2 | 95% Confidence Interval 66.3 to 95.8 | percentage of participants |
| Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Leuprolide Acetate - Overall | Week 20 | 88.9 | 95% Confidence Interval 76.0 to 96.3 | percentage of participants |
| Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Leuprolide Acetate - Previously Treated | Week 44 | 88.9 | 95% Confidence Interval 65.3 to 98.6 | percentage of participants |
1 to 10 of 165Source ClinicalTrials.gov
See all 165 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Leuprolide Acetate - Previously Treated | 18 | |
| Overall Study | STARTED | Leuprolide Acetate - Treament Naïve | 27 | |
| Overall Study | COMPLETED | Leuprolide Acetate - Previously Treated | 8 | |
| Overall Study | COMPLETED | Leuprolide Acetate - Treament Naïve | 20 | |
| Overall Study | NOT COMPLETED | Leuprolide Acetate - Previously Treated | 10 | |
| Overall Study | NOT COMPLETED | Leuprolide Acetate - Treament Naïve | 7 |
Source ClinicalTrials.gov
Adverse events226
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 | ANAEMIA | Blood and lymphatic system disorders | Leuprolide Acetate - Previously Treated | 1 | 18 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | Leuprolide Acetate - Treament Naïve | 0 | 27 | 0 |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | Leuprolide Acetate - Previously Treated | 0 | 18 | 0 |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | Leuprolide Acetate - Treament Naïve | 2 | 27 | 2 |
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | Leuprolide Acetate - Previously Treated | 1 | 18 | 1 |
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | Leuprolide Acetate - Treament Naïve | 0 | 27 | 0 |
| other | EAR PAIN | Ear and labyrinth disorders | Leuprolide Acetate - Previously Treated | 2 | 18 | 2 |
| other | EAR PAIN | Ear and labyrinth disorders | Leuprolide Acetate - Treament Naïve | 1 | 27 | 1 |
| other | EYE PAIN | Eye disorders | Leuprolide Acetate - Previously Treated | 1 | 18 | 1 |
| other | EYE PAIN | Eye disorders | Leuprolide Acetate - Treament Naïve | 1 | 27 | 1 |
1 to 10 of 226Source ClinicalTrials.gov
See all 226 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Leuprolide Acetate - Previously Treated | 0 | 18 |
| Total, all-cause mortality | Leuprolide Acetate - Treament Naïve | 0 | 27 |
| Total, other adverse events | Leuprolide Acetate - Previously Treated | 18 | 18 |
| Total, other adverse events | Leuprolide Acetate - Treament Naïve | 27 | 27 |
| Total, serious adverse events | Leuprolide Acetate - Previously Treated | 0 | 18 |
| Total, serious adverse events | Leuprolide Acetate - Treament Naïve | 1 | 27 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Leuprolide Acetate - Previously Treated vs Leuprolide Acetate - Treament Naïve: deaths from any cause | Trial comparisons |
| Leuprolide Acetate - Previously Treated vs Leuprolide Acetate - Treament Naïve: 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/NCT03695237
GET https://conductscience.org/api/trials/v1/NCT03695237/results?page=2