Puberty, PrecociousPhase 3NCT00660010

Study of Lupron Depot In The Treatment of Central Precocious Puberty

A Phase 3 study testing Lupron (leuprolide acetate) in people with Puberty, Precocious, run by Abbott at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and effective in treating children with Central Precocious Puberty (CPP), and to assess long term effects of leuprolide acetate treatment after therapy is discontinued. Read more about this study

Who is it for?: Ages Up to 10 years
Conditions the study is for: Puberty, Precocious
What is being tested?: Lupron (leuprolide acetate)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 9 sitesUnited States
Study dates: Jan 1991to Apr 2009
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 Up to 10 years
All sexes
No healthy volunteers
Child

Who may be able to join

Clinical diagnosis of isosexual central precocious puberty with onset of Tanner scores of Stage II for breast or pubic hair earlier than age 8.0 years in girls or Stage II for pubic hair or genitalia earlier than 9.0 years in boys.
Confirmation of diagnosis by a pubertal response to a gonadotropin-releasing hormone (GnRH) stimulation test (LH > 10 U/L at baseline).
Chronological age less than 9.0 years in girls or less than 10.0 years in boys at time of first dosing.
Bone age advanced at least 1 year beyond the chronological age at entry into the study.
The condition may be idiopathic or secondary to another lesion. If secondary, therapy of the primary condition will have been undertaken and stabilized.
No evidence of abnormal pituitary, adrenal, thyroid and gonadal function except for premature secretion of gonadotropins.

Who cannot join

Irradiation to the central nervous system.
Prior therapy with medroxyprogesterone acetate and/or with any GnRH analog (including prior treatment with daily subcutaneous and depot formulations of leuprolide acetate).

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Site Reference ID/Investigator# 14343
Aurora, Colorado, 80045
Site Reference ID/Investigator# 46672
Baltimore, Maryland, 21201
Site Reference ID/Investigator# 14344
Hershey, Pennsylvania, 17033
Site Reference ID/Investigator# 14342
Indianapolis, Indiana, 46202
Site Reference ID/Investigator# 46673
Phoenix, Arizona, 85006
Site Reference ID/Investigator# 46671
San Francisco, California, 94122
Site Reference ID/Investigator# 46668
Springfield, Massachusetts, 01199
Site Reference ID/Investigator# 14341
St. Petersburg, Florida, 33701
Site Reference ID/Investigator# 14921
Stanford, California, 94305

Other trials in United States

About this study

Read the detailed description

This study includes a Prestudy Period; a treatment period where subjects will receive treatment every 4 weeks until the initiation of puberty (age 12 for males and age 11 for females); a follow-up period where subjects will be observed every 6 months until physical and laboratory observations are at pubertal levels, then every 12 months for 5 years; lastly a final follow-up questionnaire is given to all subjects when they are at least 18 years old.

At the treatment visits, efficacy assessments are Tanner staging (suppression of breast development in females and genital development in males), gonadotropins (LH and FSH), sex steroids (estradiol in females and testosterone in males), ratio of bone age to chronological age, adult height compared to a standard population and predicted mature height, and age and time to regular menses in females. This protocol will also capture data from the final questionnaire about female reproductive status at adulthood including the presence of regular menses and number of pregnancies.

Conditions: Puberty, Precocious
Being tested: Lupron (leuprolide acetate)
Keywords: CPP, central precocious puberty, pediatrics, suppression of LH, Lupron, leuprolide acetate, depot formulation, GnRHa, GnRH agonist, GNRH analog, LH, Tanner staging
Medical subject headings: Puberty, Precocious

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lupron (leuprolide acetate)Drug
Also called Lupron
Leuprolide acetate was administered monthly by intramuscular injection starting at 300 mcg/kg with adjustments of 3.75 mg upward, at subsequent clinic visits based on physical and laboratory parameters. Dosing continued until NDA was approved, or until subject no longer required leuprolide acetate to treat CPP.

Study groups in NCT00660010
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Lupron (leuprolide acetate)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females)
Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of breast development in females. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of breasts. The final visit occurred at a mean age +/- SD of 11.05 +/- 1.14 years (range, 6.96 to 12.95 years).
Measured: Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit
Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males)
Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of genital development in males. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of genitals. The final visit occurred at a mean age +/- SD of 12.35 +/-1.35 years (range, 10.71 to 14.07 years).
Measured: Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

Secondary outcomes (4)

Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations
Mean peak stimulated visit LH and FSH concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of both hormone concentrations occurred at a mean age +/- SD of 11.13 +/- 1.23 (range, 6.73 to 14.07) years.
Measured: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit
Mean Stimulated Estradiol Concentrations in Females
Mean estradiol concentrations were assessed according to the DELFIA (registered trademark) assay. The lower limit of quantitation for estradiol is 5 pg/mL and measurements below this limit are given a value of 5 pg/mL. The final visit for measurement estradiol concentrations occurred at a mean age +/- SD of 10.93 +/- 1.27 (range, 5.59 to 13.24) years.
Measured: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit
Mean Stimulated Testosterone Concentrations in Males
Mean stimulated testosterone concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of testosterone occurred at a mean age +/- SD of 12.34 +/- 1.16 (range, 11.14 to 14.07) years.
Measured: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit
Mean Ratio of Bone Age to Chronological Age
Bone age was determined by radiography of the wrist according to the Fels Method. The mean ratio of bone age to chronological age provides information about the slowing of bone age progression. A score = 1 indicates that bone age is equal to chronological age.
Measured: Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 1991Apr 2009

First posted17 Apr 2008 (estimated)
Study startJan 1991
Primary completionApr 2009
Study completionApr 2009

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 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00660010
Sponsor's protocol ID: M90-516
Status last verified: Apr 2011
First submitted: 15 Apr 2008
Last updated: 12 Apr 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lee PA, Neely EK, Fuqua J, Yang D, Larsen LM, Mattia-Goldberg C, Chwalisz K. Efficacy of Leuprolide Acetate 1-Month Depot for Central Precocious Puberty (CPP): Growth Outcomes During a Prospective, Longitudinal Study. Int J Pediatr Endocrinol. 2011;2011(1):7. doi: 10.1186/1687-9856-2011-7. Epub 2011 Jul 12.
PubMed 21860633

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Natural History Study of Patients With Excess Androgen
Congenital Adrenal Hyperplasia (CAH), Familial Male-Limited Precocious Puberty (FMPP)
Active, not recruitingObservational study
First Observatory of Precocious Puberty.
Puberty, Precocious
RecruitingPhase 4
Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
Puberty Changes
RecruitingObservational study
Inherited Reproductive Disorders
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)
Central Precocious Puberty

All Puberty, Precocious trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Lupron Depot In The Treatment of Central Precocious Puberty
ClinicalTrials.gov ID: NCT00660010
Acronym / sponsor ID: M90-516
Conditions: Puberty, Precocious
Keywords: CPP, central precocious puberty, pediatrics, suppression of LH, Lupron, leuprolide acetate, depot formulation, GnRHa
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Jan 1991
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 17 Apr 2008 (estimated)
Results: Posted 20 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: Lupron (leuprolide acetate)

Who may qualify

Ages: Up to 10 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Clinical diagnosis of isosexual central precocious puberty with onset of Tanner scores of Stage II for breast or pubic hair earlier than age 8.0 years in girls or Stage II for pubic hair or genitalia earlier than 9.0 years in boys.
Confirmation of diagnosis by a pubertal response to a gonadotropin-releasing hormone (GnRH) stimulation test (LH > 10 U/L at baseline).
Chronological age less than 9.0 years in girls or less than 10.0 years in boys at time of first dosing.
Bone age advanced at least 1 year beyond the chronological age at entry into the study.
The condition may be idiopathic or secondary to another lesion. If secondary, therapy of the primary condition will have been undertaken and stabilized.

Key exclusion criteria (2 listed)

Irradiation to the central nervous system.
Prior therapy with medroxyprogesterone acetate and/or with any GnRH analog (including prior treatment with daily subcutaneous and depot formulations of leuprolide 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
Lupron (leuprolide acetate)Also: LupronLeuprolide acetate was administered monthly by intramuscular injection starting at 300 mcg/kg with adjustments of 3.75 mg upward, at subsequent clinic visits based on physical and laboratory parameters. Dosing continued until NDA was approved, or until subject no longer required leuprolide acetate to treat CPP.	Drug	1

Primary outcome

Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females)
Time frame: Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit
Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of breast development in females. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of breasts. The final visit occurred at a mean age +/- SD of 11.05 +/- 1.14 years (range, 6.96 to 12.95 years).
Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males)
Time frame: Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit
Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of genital development in males. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of genitals. The final visit occurred at a mean age +/- SD of 12.35 +/-1.35 years (range, 10.71 to 14.07 years).

4 secondary outcomes

Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations
Time frame: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit
Mean Stimulated Estradiol Concentrations in Females
Time frame: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit
Mean Stimulated Testosterone Concentrations in Males
Time frame: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit
Mean Ratio of Bone Age to Chronological Age
Time frame: Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

Results and safety

Results posted to the registry on 20 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Leuprolide Acetate 1 Month Depot	55	46

Primary outcome: Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females)

Time frame: Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit. Number. Unit: Percentage of subjects

Measure	Leuprolide Acetate 1 Month Depot n = 49
Breast development suppression - Week 4 N=44	81.8
Breast development suppression-Week 48 N=47	80.9 (66.7 to 90.9)
Breast development suppression -Week 96 N=41	87.8 (73.8 to 95.9)
Breast development suppression-Week 144 N=29	82.8 (64.2 to 94.2)
Breast development suppression - Week 192 N=18	66.7 (41.0 to 86.7)
Breast development suppression -Week 240 N=13	76.9 (46.2 to 95.0)
Breast development suppression-Final Visit N=48	77.1

Population analysed: The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 49 females (breast development suppression). Study drug was discontinued at the initiation of puberty.

Primary outcome: Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males)

Time frame: Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit. Number. Unit: Percentage of subjects

Measure	Leuprolide Acetate 1 Month Depot n = 6
Genital development suppression - Week 4 N=5	80.0
Genital development suppression - Week 48 N=6	83.3
Genital development suppression - Week 96 N=6	83.3
Genital development suppression - Week 144 N=4	75.0
Genital development suppression - Week 192 N=4	75.0
Genital development suppression - Week 240 N=3	66.7
Genital development suppression - Final Visit N=6	83.3

Population analysed: The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 6 males (genital development suppression). Study drug was discontinued at the initiation of puberty.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Leuprolide Acetate 1 Month Depot	7 of 55 (12.7%)	52 of 55 (94.5%)	Not reported

Limitations and caveats (from the sponsor): Study drug was discontinued usually at the initiation of puberty (12 years for males and 11 years for females) with the concurrence of the investigator, or at the discretion of the investigator. Adverse events are coded with the COSTART dictionary.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21860633Lee PA, Neely EK, Fuqua J, Yang D, Larsen LM, Mattia-Goldberg C, Chwalisz K. Efficacy of Leuprolide Acetate 1-Month Depot for Central Precocious Puberty (CPP): Growth Outcomes During a Prospective, Longitudinal Study. Int J Pediatr Endocrinol. 2011;2011(1):7. doi: 10.1186/1687-9856-2011-7. Epub 2011 Jul 12.

Related trials for Puberty, Precocious

RecruitingObservational study
Natural History Study of Patients With Excess Androgen
Congenital Adrenal Hyperplasia (CAH), Familial Male-Limited Precocious Puberty (FMPP)
Active, not recruitingObservational study
First Observatory of Precocious Puberty.
Puberty, Precocious
RecruitingPhase 4
Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
Puberty Changes
RecruitingObservational study
Inherited Reproductive Disorders
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)
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.

Kristof Chwalisz, MD study director

Abbott

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lupron (leuprolide acetate) in people with Puberty, Precocious, run by Abbott at 9 sites in United States.

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 6 inclusion and 2 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 12 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. 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 20 Jul 2010). 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 Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) (time frame: Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit). The study lists 2 primary outcomes in all. 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 NCT00660010, 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 12 Apr 2011.