Central Precocious Puberty (CPP)Phase 3NCT03695237
A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
A Phase 3 study testing Leuprolide Acetate (LA) in people with Central Precocious Puberty (CPP), run by AbbVie at 18 sites in 2 countries.
Trial summary
The primary objective of the study is to assess the safety and efficacy of a leuprolide acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have been previously treated with a GnRHa. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Central Precocious Puberty (CPP)
- What is being tested?
- Leuprolide Acetate (LA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 24 Oct 2018to 29 Nov 2023
- 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
- Children with CPP who are naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) (females 2 - 8 years of age, or males 2 - 9 years of age) or who have been on standard GnRHa therapy for at least 6 months (females 2 - 10 years of age, or males 2 - 11 years of age).
- No history of clinically significant medical conditions or any other reason that the investigator determines would make the participant an unsuitable candidate to receive study drug.
Who cannot join
None listed.
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States17 sites
Van Meter Pediatric Endocrinology /ID# 201688
Atlanta, Georgia, 30318-2508
Children's Hospital Colorado /ID# 201645
Aurora, Colorado, 80045
Pediatric Endocrine Associates /ID# 202396
Boston, Massachusetts, 02114
Cook Children's Med. Center /ID# 212937
Fort Worth, Texas, 76104
Pediatric Endocrine Associates /ID# 201089
Greenwood Village, Colorado, 80111
Penn State Hershey Medical Ctr /ID# 200287
Hershey, Pennsylvania, 17033-2360
Rocky Mountain Diabetes and Osteoporosis Center /ID# 209878
Idaho Falls, Idaho, 83404-7596
Indiana University /ID# 200526
Indianapolis, Indiana, 46202
Nemours Children's Health System /ID# 201331
Jacksonville, Florida, 32207
Children's Mercy Hospital/ID# 200221
Kansas City, Missouri, 64111
Pediatric Endocrinology Associates /ID# 200629
Long Beach, California, 90806-1651
University of Minnesota /ID# 200508
Minneapolis, Minnesota, 55455-1450
Arnold Palmer Hospital /ID# 201624
Orlando, Florida, 32806
Children's Hospital of Philadelphia - Main /ID# 203846
Philadelphia, Pennsylvania, 19104-4319
Rady Children's Hospital San Diego /ID# 202491
San Diego, California, 92123
Multicare Institute for Research and Innovation /ID# 202188
Tacoma, Washington, 98405
University of Oklahoma /ID# 200659
Tulsa, Oklahoma, 74135-2527
Puerto Rico1 site
Pediatric Endocrine Research Associates /ID# 200131
San Juan, 00935
About this study
Official title: A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45 mg 6-Month Depot Formulation in Children With Central Precocious Puberty (CPP)
The primary objective of the study is to assess the safety and efficacy of a leuprolide acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have been previously treated with a GnRHa.
- Conditions
- Central Precocious Puberty (CPP)
- Being tested
- Leuprolide Acetate (LA)
- Keywords
- Central Precocious Puberty (CPP), Leuprolide Acetate (LA)
- 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 (LA)Drug
Also called Lupron Depot
Administered intramuscularly as an injection
| Study group | Role | What they receive |
|---|---|---|
| Leuprolide Acetate (LA) | Experimental | Participants received leuprolide acetate (LA) 45 mg every 6 months administered as an intramuscular injection for up to 144 weeks. Receives: Drug: Leuprolide Acetate (LA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Week 24 (prior to the Week 24 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection.
Secondary outcomes (9)
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
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.
Measured: 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.
Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at 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).
Measured: Weeks 12, 20, 24, 44, and 48
Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at 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).
Measured: Weeks 12, 20, 24, 44, and 48
Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty
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.
Measured: Part 1: Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144
Parts 1 and 2: Change From Baseline in Incremental Growth Rate
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.
Measured: Part 1: Baseline and Weeks 4, 12, 20, 24, 44, and 48; Part 2: Weeks 72, 96, 120, and 144
Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age
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.
Measured: Part 1: Baseline and Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144
Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL)
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.
Measured: Weeks 72, 96, 120, and 144
Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL
Estradiol concentrations were measured from blood samples taken at each study visit prior to stimulation testing.
Measured: Weeks 72, 96, 120, and 144
Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL
Male participants with maintenance of suppression of testosterone to < 30 ng/dL are assessed
Measured: Weeks 72, 96, 120, and 144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start24 Oct 2018
- Primary completion6 May 2021
- Study completion29 Nov 2023
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.
- Other trials for Central Precocious Puberty (CPP)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695237
- Sponsor's protocol ID
- M16-904
- Status last verified
- May 2024
- First submitted
- 2 Oct 2018
- Last updated
- 29 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45 mg 6-Month Depot Formulation in Children With Central Precocious Puberty (CPP)
- ClinicalTrials.gov ID
- NCT03695237
- Acronym / sponsor ID
- M16-904
- Conditions
- Central Precocious Puberty (CPP)
- Keywords
- Central Precocious Puberty (CPP), Leuprolide Acetate (LA)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Posted 16 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to assess the safety and efficacy of a leuprolide acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have been previously treated with a GnRHa.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leuprolide Acetate (LA) | Experimental | Drug: Leuprolide Acetate (LA)Participants received leuprolide acetate (LA) 45 mg every 6 months administered as an intramuscular injection for up to 144 weeks. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with CPP who are naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) (females 2 - 8 years of age, or males 2 - 9 years of age) or who have been on standard GnRHa therapy for at least 6 months (females 2 - 10 years of age, or males 2 - 11 years of age).
- No history of clinically significant medical conditions or any other reason that the investigator determines would make the participant an unsuitable candidate to receive study drug.
Key exclusion criteria (0 listed)
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 (LA)Also: Lupron DepotAdministered intramuscularly as an injection | Drug | Leuprolide Acetate (LA) |
Primary outcome
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
Time frame: 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.
9 secondary outcomes
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
Time frame: 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.
Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48
Time frame: Weeks 12, 20, 24, 44, and 48
Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48
Time frame: Weeks 12, 20, 24, 44, and 48
Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty
Time frame: Part 1: Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144
Parts 1 and 2: Change From Baseline in Incremental Growth Rate
Time frame: Part 1: Baseline and Weeks 4, 12, 20, 24, 44, and 48; Part 2: Weeks 72, 96, 120, and 144
Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age
Time frame: Part 1: Baseline and Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144
Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL)
Time frame: Weeks 72, 96, 120, and 144
Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL
Time frame: Weeks 72, 96, 120, and 144
Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL
Time frame: Weeks 72, 96, 120, and 144
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Related trials for Central Precocious Puberty (CPP)
Active, not recruitingPhase 4
Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty
CPP
RecruitingObservational study
Idiopathic Central Precocious Puberty and Associated Neurodevelopmental Syndromes and Pathologies: Evaluation of Frequency and Comparison of Diagnostic and Developmental Characteristics
Central Precocious Puberty (CPP)
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.
ABBVIE INC. study director
AbbVie
18 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 (LA) in people with Central Precocious Puberty (CPP), run by AbbVie at 18 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 2 inclusion and 0 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 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 16 May 2023). 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 Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24 (time frame: Week 24 (prior to the Week 24 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2024.