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The purpose of this study is to determine if 11.25 and 30 mg formulations of leuprolide are effective in treating children with Central Precocious Puberty (CPP).
Study Design:
A total of 80 children with confirmed CPP were planned to be enrolled and randomized in a 1:1 ratio to receive 2 injections of either leuprolide acetate 11.25 mg or 30 mg depot formulation, each injection administered 3 mo apart (6 mo of treatment):
This study includes a 4-week Screening Period, two 3-mo treatment cycles, and a posttreatment follow-up period (12 weeks following the Mo 6 visit). Study visits will occur at Screening, Day 1, Week 2 (only for subjects participating in the pharmacokinetic subset), Mo 1, 2, 3, Mo 6/Early Termination, and 12 weeks later, for the Posttreatment Follow-up Visit.
This study was conducted at 18 sites in the United States and 4 sites in Puerto Rico.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leuprolide acetate 11.25 mg | Experimental | There are 2 arms that received leuprolide acetate 11.25 mg. Subjects who are treatment naive to leuprolide acetate are designated to be in Arm A and subjects who have previously been treated with leuprolide acetate are designated to be in Arm B. |
|
| Leuprolide acetate 30 mg | Experimental | There are 2 arms that received leuprolide acetate 30 mg. Subjects who are treatment naive to leuprolide acetate are designated to be in Arm C and subjects who have previously been treated with leuprolide acetate are designated to be in Arm D. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leuprolide acetate 11.25 mg | Drug | Two intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 mo apart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 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. | Month 2 through 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit | 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. | Month 1, 2, 3 and 6 |
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Inclusion Criteria:
Additional criteria for subjects who have not had previous treatment:
Additional criteria for subjects previously treated:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Bacher, MD, | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 8765 | Birmingham | Alabama | 35233 | United States | ||
| Site Reference ID/Investigator# 11522 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41824265 | Derived | Lim CN, Al Yacoub ON, Mostafa NM, Salem AH. Fixed Dosing of Leuprolide Acetate, a GnRH Agonist, in Children with Central Precocious Puberty: A Population Pharmacokinetic Justification. Paediatr Drugs. 2026 May;28(3):295-305. doi: 10.1007/s40272-025-00733-2. Epub 2026 Mar 13. | |
| 22344198 | Derived | Lee PA, Klein K, Mauras N, Neely EK, Bloch CA, Larsen L, Mattia-Goldberg C, Chwalisz K. Efficacy and safety of leuprolide acetate 3-month depot 11.25 milligrams or 30 milligrams for the treatment of central precocious puberty. J Clin Endocrinol Metab. 2012 May;97(5):1572-80. doi: 10.1210/jc.2011-2704. Epub 2012 Feb 16. |
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Subjects were randomized in a 1:1 ratio to 1 of the 2 treatment arms. To ensure balanced randomization, the study drug assignment was stratified on the basis of whether subjects were treatment-naive or had been treated with GnRHa previously.
Eighteen sites in the US and 4 sites in Puerto Rico enrolled subjects into the study. The first subject was randomized 17 June 2008 and the last subject was randomized 12 Aug 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Leuprolide Acetate 11.25 mg - Treatment Naive | Subjects who received at least 1 dose of study drug. |
| FG001 | Leuprolide Acetate 11.25 mg - Previous Treatment | Subjects who received at least 1 dose of study drug. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Leuprolide acetate 30 mg | Drug | Two intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 mo apart. |
|
|
| Percentage of Participants With Suppression of Testosterone in <30 ng/dL by Visit | 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. | Month 1, 2, 3 and 6 |
| Peak-stimulated Luteinizing Hormone Concentration by Visit | Observed data were used with no imputation for missing data. | Baseline, Month 1, 2, 3 and 6 |
| Percentage of Participants With Suppression of the Physical Signs of Puberty (Breast Development) at 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. | Month 6 |
| Percentage of Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) at 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. | Month 6 |
| Change From Baseline in Incremental Growth Rate (cm/Year) at 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. | Baseline and Month 6 |
| Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age at 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. | Baseline to Month 6 |
| Long Beach |
| California |
| 90806 |
| United States |
| Site Reference ID/Investigator# 8756 | Los Angeles | California | 90027 | United States |
| Site Reference ID/Investigator# 8755 | San Diego | California | 92123 | United States |
| Site Reference ID/Investigator# 8761 | San Diego | California | 92123 | United States |
| Site Reference ID/Investigator# 8772 | Stanford | California | 94305-5208 | United States |
| Site Reference ID/Investigator# 8749 | Greenwood Village | Colorado | 80111 | United States |
| Site Reference ID/Investigator# 8771 | Gainesville | Florida | 32608 | United States |
| Site Reference ID/Investigator# 8764 | Jacksonville | Florida | 32207 | United States |
| Site Reference ID/Investigator# 17621 | Pensacola | Florida | 32504 | United States |
| Site Reference ID/Investigator# 8752 | Indianapolis | Indiana | 46202 | United States |
| Site Reference ID/Investigator# 8766 | Shreveport | Louisiana | 71103 | United States |
| Site Reference ID/Investigator# 8768 | Minneapolis | Minnesota | 55455 | United States |
| Site Reference ID/Investigator# 17341 | Saint Paul | Minnesota | 55102 | United States |
| Site Reference ID/Investigator# 8759 | Kansas City | Missouri | 64108 | United States |
| Site Reference ID/Investigator# 8750 | Oklahoma City | Oklahoma | 73104 | United States |
| Site Reference ID/Investigator# 8760 | Tulsa | Oklahoma | 74135 | United States |
| Site Reference ID/Investigator# 8763 | Hershey | Pennsylvania | 17033 | United States |
| Site Reference ID/Investigator# 8754 | Salt Lake City | Utah | 84108 | United States |
| Site Reference ID/Investigator# 8762 | Seattle | Washington | 98104 | United States |
| Site Reference ID/Investigator# 8753 | Seattle | Washington | 98105 | United States |
| Site Reference ID/Investigator# 17922 | Bayamón | 00960 | Puerto Rico |
| Site Reference ID/Investigator# 17923 | Ponce | 00717-2116 | Puerto Rico |
| Site Reference ID/Investigator# 18242 | San Juan | 00936-5067 | Puerto Rico |
| Site Reference ID/Investigator# 19661 | San Juan | 00936-8344 | Puerto Rico |
| FG002 | Leuprolide Acetate 30 mg - Treatment Naive | Subjects who received at least 1 dose of study drug. |
| FG003 | Leuprolide Acetate 30 mg - Previous Treatment | Subjects who received at least 1 dose of study drug. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Leuprolide Acetate 11.25 mg - Treatment Naive | Subjects who received at least 1 dose of study drug. |
| BG001 | Leuprolide Acetate 11.25 mg - Previous Treatment | Subjects who received at least 1 dose of study drug. |
| BG002 | Leuprolide Acetate 30 mg - Treatment Naive | Subjects who received at least 1 dose of study drug. |
| BG003 | Leuprolide Acetate 30 mg - Previous Treatment | Subjects who received at least 1 dose of study drug. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 2 through 6 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 1, 2, 3 and 6 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Suppression of Testosterone in <30 ng/dL by Visit | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 1, 2, 3 and 6 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Peak-stimulated Luteinizing Hormone Concentration by Visit | Observed data were used with no imputation for missing data. | 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. | Posted | Mean | Standard Deviation | mIU/mL | Baseline, Month 1, 2, 3 and 6 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Suppression of the Physical Signs of Puberty (Breast Development) at 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 6 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) at 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 6 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Incremental Growth Rate (cm/Year) at 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. | 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. | Posted | Mean | Standard Deviation | cm/year | Baseline and Month 6 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age at 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. | 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. | Posted | Mean | Standard Deviation | Ratio | Baseline to Month 6 |
| ||||||||||||||||||||||||||||||||||||
| 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) | Percentage of participants with suppression of peak stimulated luteinizing hormone that was measured after a GnRHa stimulation test at Mo 2, 3, and 6. A simple percentage and binomial exact confidence intervals were used in this analysis. Participants who withdrew with luteinizing hormone that remained suppressed were counted as a success. This analysis was performed after the clinical study report was completed and is included to match the FDA package insert. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 2 through 6 |
| ||||||||||||||||||||||||||||||||||||
| 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 | The ratio at baseline or Month 6 was calculated as bone age at baseline or Month 6/chronological age at baseline or Month 6. The percentage of participants with a decrease in the ratio was calculated as a simple percentage for each dose group. Observed data were used with no imputation for missing data. The baseline time frame was increased from the secondary outcome in this analysis to include all participants with a bone age radiograph at screening. This analysis was performed after the clinical study report was completed & is included to match the FDA package insert. | 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. | Posted | Number | Percentage of Participants | Baseline to Month 6 |
|
Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date.
Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Leuprolide Acetate 11.25 mg - Treatment Naive | Subjects who received at least 1 dose of study drug. | 1 | 21 | 13 | 21 | ||
| EG001 | Leuprolide Acetate 11.25 mg - Previous Treatment | Subjects who received at least 1 dose of study drug. | 0 | 21 | 18 | 21 | ||
| EG002 | Leuprolide Acetate 30 mg - Treatment Naive | Subjects who received at least 1 dose of study drug. | 0 | 21 | 15 | 21 | ||
| EG003 | Leuprolide Acetate 30 mg - Previous Treatment | Subjects who received at least 1 dose of study drug. | 1 | 21 | 17 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA (12.1) |
| ||
| Nausea | Gastrointestinal disorders | MedDRA (12.1) |
| ||
| Weight Decreased | Gastrointestinal disorders | MedDRA (12.1) |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) |
| ||
| Diarrhea | Gastrointestinal disorders | MedDRA (12.1) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (12.1) |
| ||
| Ear Pain | Ear and labyrinth disorders | MedDRA (12.1) |
| ||
| Goiter | Endocrine disorders | MedDRA (12.1) |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) |
| ||
| Injection Site Pain | General disorders | MedDRA (12.1) |
| ||
| Pyrexia | General disorders | MedDRA (12.1) |
| ||
| Ear Infection | Infections and infestations | MedDRA (12.1) |
| ||
| Gastroenteritis | Infections and infestations | MedDRA (12.1) |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA (12.1) |
| ||
| Otitis Media | Infections and infestations | MedDRA (12.1) |
| ||
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (12.1) |
| ||
| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA (12.1) |
| ||
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA (12.1) |
| ||
| Weight Increased | Investigations | MedDRA (12.1) |
| ||
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.1) |
| ||
| Dizziness | Nervous system disorders | MedDRA (12.1) |
| ||
| Headache | Nervous system disorders | MedDRA (12.1) |
| ||
| Mood Altered | Psychiatric disorders | MedDRA (12.1) |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) |
| ||
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) |
| ||
| Respiratory Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) |
| ||
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) |
|
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-9110 |
| ID | Term |
|---|---|
| D011629 | Puberty, Precocious |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
Subjects who received at least 1 dose of study drug.
|
|
Subjects who received at least 1 dose of study drug.
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG003 | Leuprolide Acetate 30 mg - Previous Treatment | Subjects who received at least 1 dose of study drug. |
|
|
Subjects who received at least 1 dose of study drug.
| OG003 | Leuprolide Acetate 30 mg - Previous Treatment | Subjects who received at least 1 dose of study drug. |
|
|
| Leuprolide Acetate 30 mg - Previous Treatment |
Subjects who received at least 1 dose of study drug. |
|
|
|
Subjects who received at least 1 dose of study drug. |
|
|
|
Subjects who received at least 1 dose of study drug.
| OG003 | Leuprolide Acetate 30 mg - Previous Treatment | Subjects who received at least 1 dose of study drug. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|