DwarfismPhase 2NCT00001343
The Effects of Hormones in Growth Hormone-Treated Girls With Turner Syndrome
A Phase 2 study testing Humatrope and Oxandrolone in people with Dwarfism and Turner's Syndrome, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial summary
Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Patients with Turner syndrome are typically short, have abnormal physical features, and lack the physical changes normally associated with puberty. Read more about this study
- Who is it for?
- Ages 10 to 14 years, women only
- Conditions the study is for
- Dwarfism, Turner's Syndrome
- What is being tested?
- Humatrope and Oxandrolone
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Dec 1992to 10 Oct 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 10 to 14 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Girls with Turner syndrome will qualify to participate in this study if they meet the following criteria:
- Karyotype diagnosis compatible with Turner syndrome.
- No treatment with estrogen, androgen or growth hormone exceeding twelve months, and no treatment with either of these agents in the preceding 3 months.
- Chronological age of 10.0 to 14.9 years.
- Bone age less than or equal to 12 years.
Who cannot join
- Prior treatment with estrogen, androgen, or growth hormone for more than twelve months.
- Y component in peripheral karyotype.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107-6541
About this study
Official title: The Relative Effects of Androgen, Estrogen, and the Combination of Androgen and Estrogen on Growth Rate, GH Binding Protein, IGF-I, and Cognitive Function in Growth Hormone-Treated Girls With Turner Syndrome
Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Patients with Turner syndrome are typically short, have abnormal physical features, and lack the physical changes normally associated with puberty. In addition, some patients with Turner syndrome have low bone density (osteoporosis) and differences in learning abilities.
This study will research the effects of steroid hormones on patients with Turner syndrome. It will look closely at how taking steroid hormones effects the patient's rate of growth as well as the patient's ability to learn. In addition the study will investigate how different hormones (androgen and estrogen) work when given together as a combination.
Read more
All patients asked to participate in this study will receive growth hormone injections. However, half of the patients will receive an additional sex steroid hormone (oxandrolone) in the form of a pill. The other half of the patients will receive a placebo or "sugar pill". This will allow the researchers to determine if the combination of the hormones produces different results than growth hormone alone.
The study will last approximately 2 years. After 2 years of research the patients may qualify for an additional 2 years of treatment. Patients may benefit directly from this research with increased growth and improved ability to learn.
Read the detailed description
Turner syndrome is associated with short stature, multiple physical stigmata, and absent pubertal development. We propose to: (1) examine the effects of sex steroids (androgen) on multiple variables (growth rate, GH binding protein, IGF-I, and cognitive function), in the setting of supplemental growth hormone administration and (2) to investigate any synergistic or additive effects of the androgen and estrogen combination on the above variables.
- Conditions
- Dwarfism, Turner's Syndrome
- Being tested
- Humatrope, Oxandrolone
- Keywords
- Turner's Syndrome, Short Stature, Cognitive Function, Sex Steroids, Turner Syndrome, TS
- Medical subject headings
- Dwarfism, Turner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HumatropeDrug
OxandroloneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start11 Dec 1992
- Study completion10 Oct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DwarfismStudies 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 2
- Primary purpose
- Treatment
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001343
- Sponsor's protocol ID
- 930054
- Other IDs
- 93-CH-0054
- Status last verified
- 10 Oct 2007
- First submitted
- 3 Nov 1999
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Palmer CG, Reichmann A. Chromosomal and clinical findings in 110 females with Turner syndrome. Hum Genet. 1976 Dec 29;35(1):35-49. doi: 10.1007/BF00295617.
PubMed 1002163
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relative Effects of Androgen, Estrogen, and the Combination of Androgen and Estrogen on Growth Rate, GH Binding Protein, IGF-I, and Cognitive Function in Growth Hormone-Treated Girls With Turner Syndrome
- ClinicalTrials.gov ID
- NCT00001343
- Acronym / sponsor ID
- 930054
- Conditions
- Dwarfism, Turner's Syndrome
- Keywords
- Turner's Syndrome, Short Stature, Cognitive Function, Sex Steroids, Turner Syndrome, TS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 11 Dec 1992
- Study completion
- 10 Oct 2007
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Patients with Turner syndrome are typically short, have abnormal physical features, and lack the physical changes normally associated with puberty. In addition, some patients with Turner syndrome have low bone density (osteoporosis) and differences in learning abilities.
This study will research the effects of steroid hormones on patients with Turner syndrome. It will look closely at how taking steroid hormones effects the patient's rate of growth as well as the patient's ability to learn. In addition the study will investigate how different hormones (androgen and estrogen) work when given together as a combination.
All patients asked to participate in this study will receive growth hormone injections. However, half of the patients will receive an additional sex steroid hormone (oxandrolone) in the form of a pill. The other half of the patients will receive a placebo or "sugar pill". This will allow the researchers to determine if the combination of the hormones produces different results than growth hormone alone.
The study will last approximately 2 years. After 2 years of research the patients may qualify for an additional 2 years of treatment. Patients may benefit directly from this research with increased growth and improved ability to learn.
Detailed description
Turner syndrome is associated with short stature, multiple physical stigmata, and absent pubertal development. We propose to: (1) examine the effects of sex steroids (androgen) on multiple variables (growth rate, GH binding protein, IGF-I, and cognitive function), in the setting of supplemental growth hormone administration and (2) to investigate any synergistic or additive effects of the androgen and estrogen combination on the above variables.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 10 to 14 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Girls with Turner syndrome will qualify to participate in this study if they meet the following criteria:
- Karyotype diagnosis compatible with Turner syndrome.
- No treatment with estrogen, androgen or growth hormone exceeding twelve months, and no treatment with either of these agents in the preceding 3 months.
- Chronological age of 10.0 to 14.9 years.
- Bone age less than or equal to 12 years.
Key exclusion criteria (2 listed)
- Prior treatment with estrogen, androgen, or growth hormone for more than twelve months.
- Y component in peripheral karyotype.
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 |
|---|---|---|
| Humatrope | Drug | – |
| Oxandrolone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 1002163Palmer CG, Reichmann A. Chromosomal and clinical findings in 110 females with Turner syndrome. Hum Genet. 1976 Dec 29;35(1):35-49. doi: 10.1007/BF00295617.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Humatrope and Oxandrolone in people with Dwarfism and Turner's Syndrome, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 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 5 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001343, 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 2 Jul 2017.