PrecociousPhase 3NCT00667446
Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty
A Phase 3 study testing Leuprolide Acetate 3 Month Depot in people with Precocious and Leuprolide Acetate, run by AbbVie (prior sponsor, Abbott) at 20 sites in 2 countries.
Trial summary
The purpose of this extension study is to determine if leuprolide acetate (11.25 mg and 30 mg) is safe in treating children with Central Precocious Puberty over a longer period of time (36 months). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Precocious, Leuprolide Acetate, Luteinizing Hormone (LH)
- What is being tested?
- Leuprolide Acetate 3 Month Depot
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Dec 2008to Jan 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject completed the Treatment Period of the lead-in study, L-CP07-167 (NCT00635817), and has documented luteinizing hormone suppression as evidenced by peak-stimulated luteinizing hormone <4 mIU/mL at the Month 6 study visit of the lead-in study.
- Demonstrated suppression of the physical signs of puberty at Month 6 of the lead-in study.
- Subject is expected to receive at least 12 months of therapy to treat Central Precocious Puberty after study entry.
- 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.
Who cannot join
- Incomplete precocious puberty, peripheral precocious puberty or evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid and gonadal function (other than premature secretion of gonadotropins) not adequately controlled, unstable intracranial tumors except hamartoma.
- Bone age ≥14 years for girls and ≥15 years for boys (based on the Month 6 lead in study, L-CP07-167, radiographic results).
- Has an abnormal laboratory value suggesting a clinically significant underlying disease or condition.
- Chronic illness requiring treatment that may interfere with growth, ie, chronic steroid use, renal failure, moderate to severe scoliosis.
- Current therapy with medroxyprogesterone acetate.
- Current therapy with growth hormone.
Show all 10Show fewer
- Current therapy with insulin-like growth factor-1 (IGF-1).
- Current use of an estrogen preparation.
- Any concomitant medical condition that, in the opinion of the investigator, may expose a subject to an unacceptable level of safety risk or that affects subject compliance.
- Subject has a positive pregnancy test.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States16 sites
Site Reference ID/Investigator# 13521
Birmingham, Alabama, 35233
Site Reference ID/Investigator# 22425
Greenwood Village, Colorado, 80111
Site Reference ID/Investigator# 16506
Hershey, Pennsylvania, 17033
Site Reference ID/Investigator# 26983
Indianapolis, Indiana, 46202
Site Reference ID/Investigator# 18181
Jacksonville, Florida, 32207
Site Reference ID/Investigator# 14121
Kansas City, Missouri, 64108
Site Reference ID/Investigator# 14922
Long Beach, California, 90806
Site Reference ID/Investigator# 26043
Los Angeles, California, 90027
Site Reference ID/Investigator# 23643
Minneapolis, Minnesota, 55455
Site Reference ID/Investigator# 23802
Oklahoma City, Oklahoma, 73104
Site Reference ID/Investigator# 26364
Pensacola, Florida, 32504
Site Reference ID/Investigator# 23502
Saint Paul, Minnesota, 55102
Site Reference ID/Investigator# 20802
San Diego, California, 92123
Site Reference ID/Investigator# 14024
Seattle, Washington, 98104
Site Reference ID/Investigator# 20821
Shreveport, Louisiana, 71130-3932
Site Reference ID/Investigator# 13324
Tulsa, Oklahoma, 74135
Puerto Rico4 sites
Site Reference ID/Investigator# 23182
Bayamón, 00960
Site Reference ID/Investigator# 21721
Ponce, 00717-2116
Site Reference ID/Investigator# 25908
Rio Piedras, 00935
Site Reference ID/Investigator# 23082
San Juan, 00936-8344
About this study
Official title: A 36 Month, Multi-Center, Open-Label Extension Study to Evaluate the Safety of Leuprolide Acetate 11.25 mg and 30 mg Formulations in Children With Central Precocious Puberty
The purpose of this extension study is to determine if leuprolide acetate (11.25 mg and 30 mg) is safe in treating children with Central Precocious Puberty over a longer period of time (36 months).
Read the detailed description
This study includes a 36-month Study Drug Treatment Period (3-month treatment cycles), and a Safety Follow-up Period (12 weeks following the Month 36 visit). Participants will receive a total of twelve injections of the same treatment they received in the lead-in study, L-CP07-167 (NCT00635817) either leuprolide acetate 11.25 mg or 30 mg depot formulation. Each injection will be administered 3 months apart for up to 36 months of treatment. Study visits will occur on Day 1, Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30 and 33 (1st through the 12th leuprolide acetate depot injections, respectively), Month 36, and 12 weeks later for the Safety Follow-up Visit.
- Conditions
- Precocious, Leuprolide Acetate, Luteinizing Hormone (LH), Gonadotrophin-releasing Hormone Agonist (GnRHa), Tanner Staging, Depot Formulation
- Being tested
- Leuprolide Acetate 3 Month Depot
- Keywords
- GnRH analog, Luteinizing hormone (LH), Gonadotrophin-releasing hormone agonist(GnRHa), Suppression of LH, Gonadotrophin-releasing hormone (GnRH), CPP, Leuprolide acetate, Central Precocious Puberty, Depot formulation, Lupron, Tanner staging, Pediatrics
- 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 3 Month DepotDrug
Also called ABT-818, Lupron, Leuprorelin acetate
| Study group | Role | What they receive |
|---|---|---|
| Leuprolide Acetate 3M Depot 11.25 mg | Experimental | Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months (3M) apart. Receives: Drug: Leuprolide Acetate 3 Month Depot |
| Leuprolide Acetate 3M Depot 30 mg | Experimental | Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart. Receives: Drug: Leuprolide Acetate 3 Month Depot |
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
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.
Measured: Day 1, Months 6, 12, 24, and 36
Secondary outcomes (8)
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)
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.
Measured: Day 1, Months 3, 6, 9, 12, and 24
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)
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.
Measured: Months 6, 9, 12, 24, 30, and 36
Percentage of Male Participants With Suppression of Basal Testosterone
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.
Measured: Day 1, Months 3, 6, 9, 12, 24, 30, and 36
Mean Peak-stimulated Luteinizing Hormone Concentration by Visit
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.
Measured: Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36
Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)
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.
Measured: Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36
Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)
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.
Measured: Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36
Change From Baseline in Growth Rate
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.
Measured: 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
Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age
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).
Measured: Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startDec 2008
- Primary completionOct 2012
- Study completionJan 2013
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 (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Bacher, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667446
- Sponsor's protocol ID
- L-CP07-177
- Status last verified
- Jan 2014
- First submitted
- 24 Apr 2008
- Last updated
- 9 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lee PA, Klein K, Mauras N, Lev-Vaisler T, Bacher P. 36-month treatment experience of two doses of leuprolide acetate 3-month depot for children with central precocious puberty. J Clin Endocrinol Metab. 2014 Sep;99(9):3153-9. doi: 10.1210/jc.2013-4471. Epub 2014 Jun 13.
PubMed 24926950
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 36 Month, Multi-Center, Open-Label Extension Study to Evaluate the Safety of Leuprolide Acetate 11.25 mg and 30 mg Formulations in Children With Central Precocious Puberty
- ClinicalTrials.gov ID
- NCT00667446
- Acronym / sponsor ID
- L-CP07-177
- Conditions
- Precocious, Leuprolide Acetate, Luteinizing Hormone (LH), Gonadotrophin-releasing Hormone Agonist (GnRHa), Tanner Staging, Depot Formulation
- Keywords
- GnRH analog, Luteinizing hormone (LH), Gonadotrophin-releasing hormone agonist(GnRHa), Suppression of LH, Gonadotrophin-releasing hormone (GnRH), CPP, Leuprolide acetate, Central Precocious Puberty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Apr 2008 (estimated)
- Results
- Posted 10 Dec 2013
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 extension study is to determine if leuprolide acetate (11.25 mg and 30 mg) is safe in treating children with Central Precocious Puberty over a longer period of time (36 months).
Detailed description
This study includes a 36-month Study Drug Treatment Period (3-month treatment cycles), and a Safety Follow-up Period (12 weeks following the Month 36 visit). Participants will receive a total of twelve injections of the same treatment they received in the lead-in study, L-CP07-167 (NCT00635817) either leuprolide acetate 11.25 mg or 30 mg depot formulation. Each injection will be administered 3 months apart for up to 36 months of treatment. Study visits will occur on Day 1, Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30 and 33 (1st through the 12th leuprolide acetate depot injections, respectively), Month 36, and 12 weeks later for the Safety Follow-up Visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leuprolide Acetate 3M Depot 11.25 mg | Experimental | Drug: Leuprolide Acetate 3 Month DepotTwelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months (3M) apart. |
| Leuprolide Acetate 3M Depot 30 mg | Experimental | Drug: Leuprolide Acetate 3 Month DepotTwelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subject completed the Treatment Period of the lead-in study, L-CP07-167 (NCT00635817), and has documented luteinizing hormone suppression as evidenced by peak-stimulated luteinizing hormone <4 mIU/mL at the Month 6 study visit of the lead-in study.
- Demonstrated suppression of the physical signs of puberty at Month 6 of the lead-in study.
- Subject is expected to receive at least 12 months of therapy to treat Central Precocious Puberty after study entry.
- 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.
Key exclusion criteria (10 listed)
- Incomplete precocious puberty, peripheral precocious puberty or evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid and gonadal function (other than premature secretion of gonadotropins) not adequately controlled, unstable intracranial tumors except hamartoma.
- Bone age ≥14 years for girls and ≥15 years for boys (based on the Month 6 lead in study, L-CP07-167, radiographic results).
- Has an abnormal laboratory value suggesting a clinically significant underlying disease or condition.
- Chronic illness requiring treatment that may interfere with growth, ie, chronic steroid use, renal failure, moderate to severe scoliosis.
- Current therapy with medroxyprogesterone acetate.
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 3 Month DepotAlso: ABT-818, Lupron, Leuprorelin acetate | Drug | Leuprolide Acetate 3M Depot 11.25 mg, Leuprolide Acetate 3M Depot 30 mg |
Primary outcome
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone
Time frame: 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.
8 secondary outcomes
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)
Time frame: Day 1, Months 3, 6, 9, 12, and 24
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)
Time frame: Months 6, 9, 12, 24, 30, and 36
Percentage of Male Participants With Suppression of Basal Testosterone
Time frame: Day 1, Months 3, 6, 9, 12, 24, 30, and 36
Mean Peak-stimulated Luteinizing Hormone Concentration by Visit
Time frame: Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36
Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)
Time frame: Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36
Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)
Time frame: Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36
Change From Baseline in Growth Rate
Time frame: 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
Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age
Time frame: Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24926950Lee PA, Klein K, Mauras N, Lev-Vaisler T, Bacher P. 36-month treatment experience of two doses of leuprolide acetate 3-month depot for children with central precocious puberty. J Clin Endocrinol Metab. 2014 Sep;99(9):3153-9. doi: 10.1210/jc.2013-4471. Epub 2014 Jun 13.
- Related InfoLink provided by the sponsor.
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Natural History Study of Patients With Excess Androgen
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First Observatory of Precocious Puberty.
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Genetic Disorder, Infertility
Active, not recruitingPhase 3
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
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Not yet recruitingPhase 2
(Z)-Endoxifen in Girls With MAS-Associated Peripheral Precocious Puberty
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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
AbbVie
20 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 3 Month Depot in people with Precocious and Leuprolide Acetate, run by AbbVie (prior sponsor, Abbott) at 20 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 4 inclusion and 10 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 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 10 Dec 2013). 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 (time frame: Day 1, Months 6, 12, 24, and 36). 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 NCT00667446, which also lists 1 linked publication.
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 9 Jan 2014.