Turner SyndromePhase 3GDCTNCT00191113
Somatropin Treatment to Final Height in Turner Syndrome
A Phase 3 study testing Somatropin, Ethinyl estradiol and Medroxyprogesterone acetate in people with Turner Syndrome, run by Eli Lilly and Company at 14 sites in Canada.
Trial summary
A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promoting linear growth to final height. Read more about this study
- Who is it for?
- Ages 7 to 13 years, women only
- Conditions the study is for
- Turner Syndrome
- What is being tested?
- Somatropin, Ethinyl estradiol and Medroxyprogesterone acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 14 sitesCanada
- Study dates
- Feb 1989to Dec 2007
- 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 7 to 13 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- girl with Turner syndrome
- prepubertal, Tanner stage I breast
- height velocity less than 6 cm/year and height less than or equal to the tenth percentile for sex and age in general population
- at least 6 months (preferably 12 months) of accurate height measurements available for calculation of pre-study height velocity
- if thyroxine deficient, to have received replacement therapy, and for six months prior to enrollment have had normal thyroid function tests
Who cannot join
- prior treatment with growth hormone
- presence of a Y component in karyotype with gonads in situ
- diabetes mellitus
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Canada14 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Calgary, Alberta, T2T 5C7
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Edmonton, Alberta, T6G 2B7
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Halifax, Nova Scotia, B3J 3G9
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hamilton, Ontario, L8S 3Z5
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kingston, Ontario, K7L 3N6
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
London, Ontario, K7L 3N6
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Montreal, Quebec, H3H 1P3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Montreal, Quebec, H3T 1C5
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ottawa, Ontario, K1H 8L1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sainte-Foy, Quebec, G1V 4G2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sherbrooke, Quebec, J1G 2E8
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Toronto, Ontario, M5G 1X8
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vancouver, British Columbia, V6H 3V4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Winnipeg, Manitoba, R3E 0Z2
About this study
Official title: Humatrope Treatment to Final Height in Turner's Syndrome
A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promoting linear growth to final height.
Read the detailed description
A randomized, controlled trial of Humatrope (somatropin) treatment in girls with Turner syndrome at least 7 years old and younger than 13 at study entry.
Core study objectives are to determine the efficacy of Humatrope in promoting linear growth to final height in girls with Turner syndrome, and to assess the safety of this treatment. Core study completion criteria (protocol final height) are that the patient has both a height velocity < 2 cm per year and a bone age of 14 years or greater.
Addendum 1 provides the option of Humatrope treatment to patients who were randomized to the Control arm of the Core study and who discontinued from the study on or after December 19, 1997.
Addendum 2 objectives are: 1) to collect true final height data; 2) to evaluate hearing, tympanic membrane function and other specific areas of interest with respect to the safety of growth hormone therapy in Turner syndrome; 3) to evaluate pancreatic beta cell function (glucose metabolism) in patients previously enrolled in the Core study.
Addendum 3 objective is to determine the parental origin of the retained X chromosome of an appropriate subset of patients currently or previously enrolled in the Core study, and to determine whether this parental origin holds any predictive value for spontaneous growth or for response to growth hormone therapy.
- Conditions
- Turner Syndrome
- Being tested
- Somatropin, Ethinyl estradiol, Medroxyprogesterone acetate
- Keywords
- syndrome, Turner, Turner's, height, growth, growth hormone, somatropin, short stature, short, hearing, glucose metabolism
- Medical subject headings
- Turner Syndrome, Syndrome, Dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatropinDrug
Also called Humatrope, Growth hormone
0.05 mg/kg/dose by subcutaneous injection 6 times per week, until Core study completion criteria are met (protocol final height).
Ethinyl estradiolDrug
escalating doses 2.5-20.0 mcg tablets daily after age 13 and at least one year on study, continuing until Core study completion criteria are met.
Medroxyprogesterone acetateDrug
10 mg tablets, ten days monthly, after age 15, continuing until Core study completion criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). Receives: Drug: Ethinyl estradiol; Drug: Medroxyprogesterone acetate |
| Humatrope | Experimental | Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). Receives: Drug: Somatropin; Drug: Ethinyl estradiol; Drug: Medroxyprogesterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population
Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.
Measured: Baseline, and end of 4-year addendum
Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height
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 [NCHS] uses the NCHS US general female population reference height values for age (Kuczmarski RJ et al. 2000) as the population mean and standard deviation. Calculation of Height SDS is provided in Height SDS [Lyon] description (Baseline). Since data reported by Kuczmarski RJ et al provides US general female population standards, values of Height SDS [NCHS] for untreated patients with Turner syndrome tend to be below zero e.g, -2.0 to -4.0 SDS.
Measured: at completion of core study, or at end of 4-year addendum
Secondary outcomes (16)
Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population
Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.
Measured: every 3 months during core study, and at start and end of 4-year addendum
Height (Centimeters [cm])
Most mature measurement available, at or after attainment of Final Height.
Measured: every 3 months during core study, and at start and end of 4-year addendum
Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment
Measured: at completion of core study or beginning of addendum
Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment
Measured: at completion of core study or beginning of addendum
Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment
Measured: at completion of core study or beginning of addendum
Number of Participants With Hearing Loss, Audiologist Assessment
Sensorineural Hearing Loss (SNHL)=air conduction threshold >20 dB HL and air-bone gap ≤10 dB HL; Conductive Hearing Loss (CHL)= air conduction threshold >20 dB HL, bone conduction threshold ≤20 dB HL and air-bone gap >10 dB HL; Mixed Hearing Loss (MHL) = evidence of SNHL as defined above and CHL as defined above, in the same ear; Unspecified Hearing Loss (UHL)= abnormal hearing with none of SNHL, CHL, or MHL present.
Measured: at completion of core study or beginning of addendum
Fasting Glucose, Change From Baseline
Change from core study baseline to addendum 2 maximum.
Measured: At core study baseline, and at end of 4-year addendum
Maximum Fasting Glucose Value
Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.
Measured: At start and through end of 4-year addendum (up to an additional 2 years)
Number of Participants With Any Abnormal Fasting Glucose Value
Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Glucose=Fasting Glucose >=100 milligrams per deciliter (mg/dL).
Measured: At start and through end of 4-year addendum
Maximum Fasting Insulin Values
Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.
Measured: At start and through end of 4-year addendum (up to an additional 2 years)
Number of Participants With Any Abnormal Fasting Insulin Value
Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Insulin = Fasting Insulin >=35 micro International Units per milliliter (uIU/mL).
Measured: At start and through end of 4-year addendum
Minimum Fasting Glucose/Insulin Ratio Values
Minimum measured value over addendum. In special cases an additional measurement is taken at 2 years.
Measured: At start and through end of 4-year addendum (up to an additional 2 years)
Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value
Indicates if patient had any measured value below threshold of normality at any visit during addendum. Abnormal Fasting Glucose/Insulin Ratio = Fasting Glucose/Insulin Ratio <=4.5 milligrams per 10^-4 Units (mg/10^-4U).
Measured: At start and through end of 4-year addendum
Glycosylated Hemoglobin, Change From Baseline
Change from core study baseline to addendum 2 maximum.
Measured: At core study baseline, and at end of 4-year addendum
Maximum Glycosylated Hemoglobin
Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.
Measured: At start and through end of 4-year addendum (up to an additional 2 years)
Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value
Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Glycosylated Hemoglobin = HbA1c ≥6.8% (up until 11-May-1998); and then HbA1c ≥6.1% (from 19-May-1998 onwards).
Measured: At start and through end of 4-year addendum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startFeb 1989
- Primary completionDec 2007
- Study completionDec 2007
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 (5)Papers the sponsor has linked to this study.
- Other trials for Turner SyndromeStudies 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
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00191113
- Sponsor's protocol ID
- 817/4419
- Other IDs
- #817 B9R-CA-GDCT Core study, #4419 GDCT/1 Addenda
- Acronym
- GDCT
- Status last verified
- Dec 2009
- First submitted
- 12 Sep 2005
- Last updated
- 27 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lyon AJ, Preece MA, Grant DB. Growth curve for girls with Turner syndrome. Arch Dis Child. 1985 Oct;60(10):932-5. doi: 10.1136/adc.60.10.932.
PubMed 4062345Kuczmarski RJ, Ogden CL, Grummer-Strawn LM, Flegal KM, Guo SS, Wei R, Mei Z, Curtin LR, Roche AF, Johnson CL. CDC growth charts: United States. Adv Data. 2000 Jun 8;(314):1-27.
PubMed 11183293Hamelin CE, Anglin G, Quigley CA, Deal CL. Genomic imprinting in Turner syndrome: effects on response to growth hormone and on risk of sensorineural hearing loss. J Clin Endocrinol Metab. 2006 Aug;91(8):3002-10. doi: 10.1210/jc.2006-0490. Epub 2006 Jun 6.
PubMed 16757526Stephure DK; Canadian Growth Hormone Advisory Committee. Impact of growth hormone supplementation on adult height in turner syndrome: results of the Canadian randomized controlled trial. J Clin Endocrinol Metab. 2005 Jun;90(6):3360-6. doi: 10.1210/jc.2004-2187. Epub 2005 Mar 22.
PubMed 15784709Taback SP, Van Vliet G. Health-related quality of life of young adults with Turner syndrome following a long-term randomized controlled trial of recombinant human growth hormone. BMC Pediatr. 2011 May 29;11:49. doi: 10.1186/1471-2431-11-49.
PubMed 21619701
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humatrope Treatment to Final Height in Turner's Syndrome
- ClinicalTrials.gov ID
- NCT00191113
- Acronym / sponsor ID
- GDCT / 817/4419
- Conditions
- Turner Syndrome
- Keywords
- syndrome, Turner, Turner's, height, growth, growth hormone, somatropin, short stature
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 1989
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Posted 27 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promoting linear growth to final height.
Detailed description
A randomized, controlled trial of Humatrope (somatropin) treatment in girls with Turner syndrome at least 7 years old and younger than 13 at study entry.
Core study objectives are to determine the efficacy of Humatrope in promoting linear growth to final height in girls with Turner syndrome, and to assess the safety of this treatment. Core study completion criteria (protocol final height) are that the patient has both a height velocity < 2 cm per year and a bone age of 14 years or greater.
Addendum 1 provides the option of Humatrope treatment to patients who were randomized to the Control arm of the Core study and who discontinued from the study on or after December 19, 1997.
Addendum 2 objectives are: 1) to collect true final height data; 2) to evaluate hearing, tympanic membrane function and other specific areas of interest with respect to the safety of growth hormone therapy in Turner syndrome; 3) to evaluate pancreatic beta cell function (glucose metabolism) in patients previously enrolled in the Core study.
Addendum 3 objective is to determine the parental origin of the retained X chromosome of an appropriate subset of patients currently or previously enrolled in the Core study, and to determine whether this parental origin holds any predictive value for spontaneous growth or for response to growth hormone therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | Drug: Ethinyl estradiol, Drug: Medroxyprogesterone acetateControl arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). |
| Humatrope | Experimental | Drug: Somatropin, Drug: Ethinyl estradiol, Drug: Medroxyprogesterone acetateHumatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- girl with Turner syndrome
- prepubertal, Tanner stage I breast
- height velocity less than 6 cm/year and height less than or equal to the tenth percentile for sex and age in general population
- at least 6 months (preferably 12 months) of accurate height measurements available for calculation of pre-study height velocity
- if thyroxine deficient, to have received replacement therapy, and for six months prior to enrollment have had normal thyroid function tests
Key exclusion criteria (3 listed)
- prior treatment with growth hormone
- presence of a Y component in karyotype with gonads in situ
- diabetes mellitus
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: Humatrope, Growth hormone0.05 mg/kg/dose by subcutaneous injection 6 times per week, until Core study completion criteria are met (protocol final height). | Drug | Humatrope |
| Ethinyl estradiolescalating doses 2.5-20.0 mcg tablets daily after age 13 and at least one year on study, continuing until Core study completion criteria are met. | Drug | Control, Humatrope |
| Medroxyprogesterone acetate10 mg tablets, ten days monthly, after age 15, continuing until Core study completion criteria are met. | Drug | Control, Humatrope |
Primary outcome
Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population
Time frame: Baseline, and end of 4-year addendum
Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.
Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height
Time frame: at completion of core study, or at end of 4-year addendum
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 [NCHS] uses the NCHS US general female population reference height values for age (Kuczmarski RJ et al. 2000) as the population mean and standard deviation. Calculation of Height SDS is provided in Height SDS [Lyon] description (Baseline). Since data reported by Kuczmarski RJ et al provides US general female population standards, values of Height SDS [NCHS] for untreated patients with Turner syndrome tend to be below zero e.g, -2.0 to -4.0 SDS.
16 secondary outcomes
Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population
Time frame: every 3 months during core study, and at start and end of 4-year addendum
Height (Centimeters [cm])
Time frame: every 3 months during core study, and at start and end of 4-year addendum
Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment
Time frame: at completion of core study or beginning of addendum
Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment
Time frame: at completion of core study or beginning of addendum
Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment
Time frame: at completion of core study or beginning of addendum
Number of Participants With Hearing Loss, Audiologist Assessment
Time frame: at completion of core study or beginning of addendum
Fasting Glucose, Change From Baseline
Time frame: At core study baseline, and at end of 4-year addendum
Maximum Fasting Glucose Value
Time frame: At start and through end of 4-year addendum (up to an additional 2 years)
Number of Participants With Any Abnormal Fasting Glucose Value
Time frame: At start and through end of 4-year addendum
Maximum Fasting Insulin Values
Time frame: At start and through end of 4-year addendum (up to an additional 2 years)
Number of Participants With Any Abnormal Fasting Insulin Value
Time frame: At start and through end of 4-year addendum
Minimum Fasting Glucose/Insulin Ratio Values
Time frame: At start and through end of 4-year addendum (up to an additional 2 years)
Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value
Time frame: At start and through end of 4-year addendum
Glycosylated Hemoglobin, Change From Baseline
Time frame: At core study baseline, and at end of 4-year addendum
Maximum Glycosylated Hemoglobin
Time frame: At start and through end of 4-year addendum (up to an additional 2 years)
Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value
Time frame: At start and through end of 4-year addendum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 4062345Lyon AJ, Preece MA, Grant DB. Growth curve for girls with Turner syndrome. Arch Dis Child. 1985 Oct;60(10):932-5. doi: 10.1136/adc.60.10.932.
- Background: PubMed 11183293Kuczmarski RJ, Ogden CL, Grummer-Strawn LM, Flegal KM, Guo SS, Wei R, Mei Z, Curtin LR, Roche AF, Johnson CL. CDC growth charts: United States. Adv Data. 2000 Jun 8;(314):1-27.
- Results publication: PubMed 16757526Hamelin CE, Anglin G, Quigley CA, Deal CL. Genomic imprinting in Turner syndrome: effects on response to growth hormone and on risk of sensorineural hearing loss. J Clin Endocrinol Metab. 2006 Aug;91(8):3002-10. doi: 10.1210/jc.2006-0490. Epub 2006 Jun 6.
- Results publication: PubMed 15784709Stephure DK; Canadian Growth Hormone Advisory Committee. Impact of growth hormone supplementation on adult height in turner syndrome: results of the Canadian randomized controlled trial. J Clin Endocrinol Metab. 2005 Jun;90(6):3360-6. doi: 10.1210/jc.2004-2187. Epub 2005 Mar 22.
- Derived from this study: PubMed 21619701Taback SP, Van Vliet G. Health-related quality of life of young adults with Turner syndrome following a long-term randomized controlled trial of recombinant human growth hormone. BMC Pediatr. 2011 May 29;11:49. doi: 10.1186/1471-2431-11-49.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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.
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
14 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 Somatropin, Ethinyl estradiol and Medroxyprogesterone acetate in people with Turner Syndrome, run by Eli Lilly and Company at 14 sites in Canada.
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 3 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 27 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Canada. 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 27 Jan 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?
Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population (time frame: Baseline, and end of 4-year addendum). 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 NCT00191113, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2010.