Puberty, PrecociousPhase 3NCT00635817
A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty
A Phase 3 study testing Leuprolide acetate 11.25 mg and Leuprolide acetate 30 mg in people with Puberty, Precocious, run by Abbott at 25 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Puberty, Precocious
- What is being tested?
- Leuprolide acetate 11.25 mg and Leuprolide acetate 30 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Jun 2008to Jun 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject has a clinical diagnosis of CPP.
- Eligible to receive at least 6 mo of therapy to treat CPP after study entry.
- Bone age advanced at least 1 year beyond the chronological age at time of diagnosis or first treatment.
- In general good health with no uncontrolled, clinically significant disease which would interfere with bone maturation or mask the objectives of this protocol as assessed by the investigator.
- Additional criteria for subjects who have not had previous treatment:
- Girls 2-8 years inclusive or Boys 2-9 years inclusive at Day 1.
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- Has pretreatment pubertal response to leuprolide acetate stimulation (luteinizing hormone ≥8 mIU/mL) at Screening.
- Breast pubertal staging of at least 2 in girls; testicular volume of at least 4 cc or testicular length greater than 2.5 cm in boys at Screening.
- Additional criteria for subjects previously treated:
- Girls 2-10 years inclusive or boys 2-11 years inclusive at Day 1.
- Must have been on standard gonadotropin releasing hormone analog therapy for at least the 6 mo prior to Day 1.
- Has documented maintenance of luteinizing hormone suppression as evidenced by peak stimulated level <4 mIU/mL at Screening.
Who cannot join
- Incomplete precocious puberty (premature thelarche, premature adrenarche).
- Peripheral precocious puberty: gonadal or adrenal tumors, congenital adrenal hyperplasia, testotoxicosis in boys, human chorionic gonadotropin secreting tumor or McCune-Albright syndrome in girls.
- Evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid and gonadal function other than premature secretion of gonadotropins not adequately controlled.
- Unstable intracranial tumors (unresponsive to treatment/expanding) except hamartoma.
- Previous treatment with GnRHa therapy requiring leuprolide acetate for depot suspension >15 mg monthly.
- Bone age >13 years for girls and >14 years for boys.
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- Any other condition interfering with growth, ie, skeletal dysplasia, cerebral palsy.
- Chronic illness requiring treatment that may interfere with growth, ie, chronic steroid use, renal failure, moderate to severe scoliosis.
- Diagnosis of short stature, ie more than 2.25 standard deviations below the mean height for age (growth chart measurement).
- Prior or current therapy with medroxyprogesterone acetate or growth hormone.
- Has an abnormal laboratory value suggesting a clinically significant underlying disease .
- Creatinine >1.5 mg/dL, alanine aminotransferase and/or aspartate aminotransferase >2.0 x upper limit of normal, or total bilirubin >2.0 mg/dL with aspartate aminotransferase/alanine aminotransferase elevated above normal limits.
- Positive pregnancy test.
- Known hypersensitivity to study medication or its excipients.
- Participation in another drug research within 3 mo of enrollment into this study.
- Prior or current therapy with insulin-like growth factor-1.
- Use of an estrogen preparation within 2 mo prior to Day 1.
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States21 sites
Site Reference ID/Investigator# 8765
Birmingham, Alabama, 35233
Site Reference ID/Investigator# 8771
Gainesville, Florida, 32608
Site Reference ID/Investigator# 8749
Greenwood Village, Colorado, 80111
Site Reference ID/Investigator# 8763
Hershey, Pennsylvania, 17033
Site Reference ID/Investigator# 8752
Indianapolis, Indiana, 46202
Site Reference ID/Investigator# 8764
Jacksonville, Florida, 32207
Site Reference ID/Investigator# 8759
Kansas City, Missouri, 64108
Site Reference ID/Investigator# 11522
Long Beach, California, 90806
Site Reference ID/Investigator# 8756
Los Angeles, California, 90027
Site Reference ID/Investigator# 8768
Minneapolis, Minnesota, 55455
Site Reference ID/Investigator# 8750
Oklahoma City, Oklahoma, 73104
Site Reference ID/Investigator# 17621
Pensacola, Florida, 32504
Site Reference ID/Investigator# 17341
Saint Paul, Minnesota, 55102
Site Reference ID/Investigator# 8754
Salt Lake City, Utah, 84108
Site Reference ID/Investigator# 8755
San Diego, California, 92123
Site Reference ID/Investigator# 8761
San Diego, California, 92123
Site Reference ID/Investigator# 8762
Seattle, Washington, 98104
Site Reference ID/Investigator# 8753
Seattle, Washington, 98105
Site Reference ID/Investigator# 8766
Shreveport, Louisiana, 71103
Site Reference ID/Investigator# 8772
Stanford, California, 94305-5208
Site Reference ID/Investigator# 8760
Tulsa, Oklahoma, 74135
Puerto Rico4 sites
Site Reference ID/Investigator# 17922
Bayamón, 00960
Site Reference ID/Investigator# 17923
Ponce, 00717-2116
Site Reference ID/Investigator# 18242
San Juan, 00936-5067
Site Reference ID/Investigator# 19661
San Juan, 00936-8344
About this study
Official title: A Phase 3, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Leuprolide Acetate 11.25 and 30 mg Formulations in Children With Central Precocious Puberty
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).
Read the detailed description
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.
- Conditions
- Puberty, Precocious
- Being tested
- Leuprolide acetate 11.25 mg, Leuprolide acetate 30 mg
- Keywords
- CPP, central precocious puberty, pediatrics, suppression of luteinizing hormone, Lupron, leuprolide acetate, depot formulation, GnRHa, GnRH agonist, GnRH analog, luteinizing hormone
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuprolide acetate 11.25 mgDrug
Also called ABT-818, leuprolide acetate, Lupron
Two intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 mo apart.
Leuprolide acetate 30 mgDrug
Also called ABT-818, leuprolide acetate, Lupron
Two intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 mo apart.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Leuprolide acetate 11.25 mg |
| 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. Receives: Drug: Leuprolide acetate 30 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 2 through 6
Secondary outcomes (7)
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.
Measured: Month 1, 2, 3 and 6
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.
Measured: Month 1, 2, 3 and 6
Peak-stimulated Luteinizing Hormone Concentration by Visit
Observed data were used with no imputation for missing data.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Puberty, PrecociousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Bacher, MD,, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635817
- Sponsor's protocol ID
- L-CP07-167
- Status last verified
- Oct 2011
- First submitted
- 7 Mar 2008
- Last updated
- 2 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 41824265Lee 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.
PubMed 22344198
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Leuprolide Acetate 11.25 and 30 mg Formulations in Children With Central Precocious Puberty
- ClinicalTrials.gov ID
- NCT00635817
- Acronym / sponsor ID
- L-CP07-167
- Conditions
- Puberty, Precocious
- Keywords
- CPP, central precocious puberty, pediatrics, suppression of luteinizing hormone, Lupron, leuprolide acetate, depot formulation, GnRHa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Posted 9 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leuprolide acetate 11.25 mg | Experimental | Drug: Leuprolide acetate 11.25 mgThere 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 | Drug: Leuprolide acetate 30 mgThere 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. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Subject has a clinical diagnosis of CPP.
- Eligible to receive at least 6 mo of therapy to treat CPP after study entry.
- Bone age advanced at least 1 year beyond the chronological age at time of diagnosis or first treatment.
- In general good health with no uncontrolled, clinically significant disease which would interfere with bone maturation or mask the objectives of this protocol as assessed by the investigator.
- Girls 2-8 years inclusive or Boys 2-9 years inclusive at Day 1.
Key exclusion criteria (17 listed)
- Incomplete precocious puberty (premature thelarche, premature adrenarche).
- Peripheral precocious puberty: gonadal or adrenal tumors, congenital adrenal hyperplasia, testotoxicosis in boys, human chorionic gonadotropin secreting tumor or McCune-Albright syndrome in girls.
- Evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid and gonadal function other than premature secretion of gonadotropins not adequately controlled.
- Unstable intracranial tumors (unresponsive to treatment/expanding) except hamartoma.
- Previous treatment with GnRHa therapy requiring leuprolide acetate for depot suspension >15 mg monthly.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leuprolide acetate 11.25 mgAlso: ABT-818, leuprolide acetate, LupronTwo intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 mo apart. | Drug | Leuprolide acetate 11.25 mg |
| Leuprolide acetate 30 mgAlso: ABT-818, leuprolide acetate, LupronTwo intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 mo apart. | Drug | Leuprolide acetate 30 mg |
Primary outcome
Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 6
Time frame: 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.
7 secondary outcomes
Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit
Time frame: Month 1, 2, 3 and 6
Percentage of Participants With Suppression of Testosterone in <30 ng/dL by Visit
Time frame: Month 1, 2, 3 and 6
Peak-stimulated Luteinizing Hormone Concentration by Visit
Time frame: Baseline, Month 1, 2, 3 and 6
Percentage of Participants With Suppression of the Physical Signs of Puberty (Breast Development) at Month 6
Time frame: Month 6
Percentage of Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) at Month 6
Time frame: Month 6
Change From Baseline in Incremental Growth Rate (cm/Year) at Month 6
Time frame: Baseline and Month 6
Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age at Month 6
Time frame: Baseline to Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41824265Lim 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.
- Derived from this study: PubMed 22344198Lee 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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Central Precocious Puberty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Bacher, MD, study director
Abbott
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Leuprolide acetate 11.25 mg and Leuprolide acetate 30 mg in people with Puberty, Precocious, run by Abbott at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 6 (time frame: Month 2 through 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00635817, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2011.