Idiopathic Short Stature (ISS)Phase 3PhoenixNCT00355030

Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature

A Phase 3 study testing somatropin and leuprorelin in people with Idiopathic Short Stature (ISS), run by Eli Lilly and Company at 19 sites in 2 countries.

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 present randomized trial was initially intended to study the benefits of a combined treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for pubertal children with idiopathic short stature. However, treatments were stopped in January 2012 at the request of the French drug agency. Read more about this study

Who is it for?: Ages 8 years to 171 months
Conditions the study is for: Idiopathic Short Stature (ISS)
What is being tested?: somatropin and leuprorelin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 19 sitesin 2 countries
Study dates: Jun 2006to Jul 2015
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 8 years to 171 months
All sexes
No healthy volunteers
Child

Who may be able to join

male or female children with ISS
age greater than or equal to 8 years and less than or equal to 12 years and 3 months for girls and greater than or equal to 9 years and less than or equal to 14 years and 3 months for boys
bone age less than or equal to 12.0 years for girls and less than or equal to 14.0 years for boys based on a central reading of an X-ray of the left hand and wrist
Pubertal stage B2 and B3 for girls based on the Tanner method
Pubertal stage G2 and G3 for boys based on the Tanner method

Who cannot join

Growth hormone deficiency (GHD)
Insulin-like growth factor-I levels greater than 3 SDS
Chromosomal abnormality diagnosed locally on a karyotype. For girls, the karyotype to eliminate a Turner syndrome, is mandatory
Small for gestational age (SGA)
Has reached menarche (had her first menstrual period)
Have any significant concomitant disease that is likely to interfere with growth or with the study, or is a known contraindication to Growth Hormone treatment

Trial locations and contacts

19 sites in 2 countries.

Country

City, postcode or hospital

19 sites in 2 countries

France17 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Amiens, 80084
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Besançon, 25030
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Bordeaux, 33076
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Boulogne, 92100
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Le Havre, 76083
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Lille, 59037
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Lyon, 69322
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Marseille, 13385
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Nice, 06200
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Paris, 75743
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Reims, 51092
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rennes, 35056
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rouen, 76036
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Saint-Etienne, 42055
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Strasbourg, 67 098
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tarbes, 65000
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Toulouse, 31026

Other trials in France

Netherlands2 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nijmegen, 6525 GM
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rotterdam, 3015 GD

Other trials in Netherlands

About this study

Official title: Efficacy and Safety of Somatropin in Combination With Leuprorelin Compared to Somatropin Alone in Pubertal Children With Idiopathic Short Stature

Study Period 1 involved combined treatment with somatropin and leuprorelin or treatment with somatropin alone. Participants from France who participated in this Period 1 of the study were asked to participate in a long term safety follow up defined as a Period 2 of the study. Participants from the Netherlands were offered participation in Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS, clinicaltrials.gov Identifier: NCT01088412) for long term safety follow up independent of this study.

Conditions: Idiopathic Short Stature (ISS)
Being tested: somatropin, leuprorelin

What participants receive

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

somatropinDrug
Also called LY137998, Humatrope
0.05 mg/kg/day
leuprorelinDrug
11.25 mg/3 months

Study groups in NCT00355030
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: somatropin; Drug: leuprorelin
2	Experimental	Not described Receives: Drug: somatropin

What is being measured

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

Number of Participants With One or More Drug-related Adverse Events
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Measured: Baseline through End of Study (up to 9 years)
Adult Height Standard Deviation Score (SDS)
The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Measured: Baseline through End of Study (up to 9 years)

Secondary outcomes (7)

Height Velocity
Height velocity is the difference between 2 height measurements, divided by years elapsed between measurements.
Measured: Baseline through End of Study (up to 9 years)
Height SDS
SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Measured: Baseline through End of Study (up to 9 years)
Difference Between Adult Height SDS and Target Height SDS
This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of target height [calculated as (mother's height (SDS) + father's height (SDS))/2] for particular participant.
The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Measured: Baseline through End of Study (up to 9 years)
Difference Between Adult Height SDS and Baseline Predicted Height SDS
This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline predicted height [calculated using the Bayley-Pinneau method based on height and bone age] for particular participant.
The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Measured: Baseline through End up Study (up to 9 years)
Difference Between Adult Height SDS and Baseline Height SDS
This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline height for particular participant.
The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Measured: Baseline through End up Study (up to 9 years)
Percentage of Children With Normal Adult Height SDS
Percentage of children with normal adult height SDS (greater than -2 SDS and less than +2 SDS)
Measured: Baseline through End of Study (up to 9 years)
Bone Age
Bone age measured using the X-Ray of left hand and wrist.
Measured: Baseline through End of Study (up to 9 years)

Timeline

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

Jun 2006Jul 2015

First posted20 Jul 2006 (estimated)
Study startJun 2006
Primary completionJul 2015
Study completionJul 2015

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 Idiopathic Short Stature (ISS)Studies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00355030
Sponsor's protocol ID: 9861
Other IDs: B9R-FP-GDGI
Acronym: Phoenix
Status last verified: Sep 2019
First submitted: 18 Jul 2006
Last updated: 30 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement

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

RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Recruiting
A Clinical Study of Long-Term Administration of Inpegsomatropin Injection in Participants With Idiopathic Short Stature Who Have Completed Phase Ⅲ Clinical Trials
Idiopathic Short Stature
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Human Growth Hormone Injection (Sinotropin AQ) for the Treatment of Children With Idiopathic Short Stature
Idiopathic Short Stature (ISS)
Active, not recruitingPhase 3
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
SGA, Turner Syndrome
RecruitingObservational study
Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
Growth Hormone Deficiency, Idiopathic Short Stature

All Idiopathic Short Stature (ISS) trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Somatropin in Combination With Leuprorelin Compared to Somatropin Alone in Pubertal Children With Idiopathic Short Stature
ClinicalTrials.gov ID: NCT00355030
Acronym / sponsor ID: Phoenix / 9861
Conditions: Idiopathic Short Stature (ISS)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 20 Jul 2006 (estimated)
Results: Posted 18 Oct 2016

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: somatropin, Drug: leuprorelin
2	Experimental	Drug: somatropin

Who may qualify

Ages: 8 years to 171 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

male or female children with ISS
age greater than or equal to 8 years and less than or equal to 12 years and 3 months for girls and greater than or equal to 9 years and less than or equal to 14 years and 3 months for boys
bone age less than or equal to 12.0 years for girls and less than or equal to 14.0 years for boys based on a central reading of an X-ray of the left hand and wrist
Pubertal stage B2 and B3 for girls based on the Tanner method
Pubertal stage G2 and G3 for boys based on the Tanner method

Key exclusion criteria (6 listed)

Growth hormone deficiency (GHD)
Insulin-like growth factor-I levels greater than 3 SDS
Chromosomal abnormality diagnosed locally on a karyotype. For girls, the karyotype to eliminate a Turner syndrome, is mandatory
Small for gestational age (SGA)
Has reached menarche (had her first menstrual period)

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
somatropinAlso: LY137998, Humatrope0.05 mg/kg/day	Drug	1, 2
leuprorelin11.25 mg/3 months	Drug	1

Primary outcome

Number of Participants With One or More Drug-related Adverse Events
Time frame: Baseline through End of Study (up to 9 years)
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Adult Height Standard Deviation Score (SDS)
Time frame: Baseline through End of Study (up to 9 years)
The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.

7 secondary outcomes

Height Velocity
Time frame: Baseline through End of Study (up to 9 years)
Height SDS
Time frame: Baseline through End of Study (up to 9 years)
Difference Between Adult Height SDS and Target Height SDS
Time frame: Baseline through End of Study (up to 9 years)
Difference Between Adult Height SDS and Baseline Predicted Height SDS
Time frame: Baseline through End up Study (up to 9 years)
Difference Between Adult Height SDS and Baseline Height SDS
Time frame: Baseline through End up Study (up to 9 years)
Percentage of Children With Normal Adult Height SDS
Time frame: Baseline through End of Study (up to 9 years)
Bone Age
Time frame: Baseline through End of Study (up to 9 years)

Results and safety

Results posted to the registry on 18 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Somatropin and Leuprorelin: Experimental Arm 1	46	1
Somatropin: Experimental Arm 2	45	1

Primary outcome: Number of Participants With One or More Drug-related Adverse Events

Time frame: Baseline through End of Study (up to 9 years). Number. Unit: participants

Measure	Somatropin and Leuprorelin n = 46	Somatropin n = 45
Study Period 1 (n=46, 45)	42	38
Study Period 2 (n=20, 19)	11	9

Population analysed: All participants who received at least one dose of study drug in Period 1 and all participants who entered Period 2 (safety population).

Primary outcome: Adult Height Standard Deviation Score (SDS)

Time frame: Baseline through End of Study (up to 9 years). Mean (Standard Deviation). Unit: standard deviation score

Measure	Somatropin and Leuprorelin n = 19	Somatropin n = 16
Value	-1.8 (0.53)	-1.9 (0.77)

Population analysed: All participants who received at least one dose of study drug with at least one follow up visit.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Somatropin and Leuprorelin	12 of 46 (26.1%)	41 of 46 (89.1%)	Not reported
Somatropin	7 of 45 (15.6%)	36 of 45 (80%)	Not reported

Limitations and caveats (from the sponsor): No statistical analyses was performed after the early treatment termination. All data represented is descriptive statistics only and no confirmatory conclusions can be drawn from this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement

Related trials for Idiopathic Short Stature (ISS)

RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Recruiting
A Clinical Study of Long-Term Administration of Inpegsomatropin Injection in Participants With Idiopathic Short Stature Who Have Completed Phase Ⅲ Clinical Trials
Idiopathic Short Stature
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Human Growth Hormone Injection (Sinotropin AQ) for the Treatment of Children With Idiopathic Short Stature
Idiopathic Short Stature (ISS)
Active, not recruitingPhase 3
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
SGA, Turner Syndrome
RecruitingObservational study
Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
Growth Hormone Deficiency, Idiopathic Short Stature

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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

19 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 somatropin and leuprorelin in people with Idiopathic Short Stature (ISS), run by Eli Lilly and Company at 19 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 5 inclusion and 6 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 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France, Netherlands. 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 18 Oct 2016). 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?

Number of Participants With One or More Drug-related Adverse Events (time frame: Baseline through End of Study (up to 9 years)). 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 NCT00355030.

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 30 Sep 2019.