Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00001221 · ClinicalTrials.gov registry record · Phase 2
Effect of Biosynthetic Growth Hormone and/or Ethinyl Estradiol on Adult Height in Patients With Turner Syndrome
A Phase 2 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
NCT00001221: Completed Phase 2 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00001221 is a Phase 2 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 160 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001221, a Phase 2 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
Study Summary
Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Girls with Turner syndrome are very short as children and as adults. Although their growth hormone secretion is almost always normal, giving injections of growth hormone to Turner syndrome girls may increase their rate of growth. In addition, most girls with Turner syndrome do not have normal ovaries. In normal girls the ovaries begin producing small amounts of the female sex hormone, estrogen at about 11 - 12 years of age. As girls grow older the level of estrogen increases. Estrogen is responsible for the changes in girls known as feminization. During feminization the hips grow wider, the breasts develop, there is an increase in the rate of growth, and eventually girls experience their first menstrual period. This study was designed to evaluate the effect of low dose estrogen, growth hormone, and the combination of low dose estrogen and growth hormone on adult height in girls with Turner syndrome. Patients will be entered into the study from ages 5 to 12 and will be randomly placed into one of four groups. 1. Group one will receive low dose estrogen 2. Group two will receive growth hormone 3. Group three will receive both low dose estrogen and growth hormone 4. Group four will receive a placebo "sugar pill" Once started, the treatment will continue until the patients approach their adult height, and growth slows to less than 1/2 inch over the preceding year. This usually occurs by the age of 15 or 16. Patients will be seen at the outpatient clinic every 6 months during the study and will receive a routine check-up with blood and urine tests, and hand/wrist X-rays to determine bone age. On patient's yearly visits they will have the density of bone measured in their spine and forearm.
Interventions
- DRUG Growth Hormone (Humatrope)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 1987-09 |
| Est. Completion | 2003-09 |
| Phase | Phase 2 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT00001221 record still lists
NCT00001221 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 1 intervention - of which Growth Hormone (Humatrope) is the first listed.
NCT00001221 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001221 about?
NCT00001221 is a clinical study titled "Effect of Biosynthetic Growth Hormone and/or Ethinyl Estradiol on Adult Height in Patients With Turner Syndrome". Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Girls with Turner syndrome are very short as children and as adults. Although their growth hormone secretion is almost always normal, giving injections of growth hormone to Turner syndrome girls may increase...
What is the current status of trial NCT00001221?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 1987-09. Estimated completion is 2003-09.
What interventions are being tested in trial NCT00001221?
The interventions under investigation include: Growth Hormone (Humatrope) (DRUG).
Who is sponsoring clinical trial NCT00001221?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001221's enrollment target sits among peer trials
160 422nd of 2000 higher than 1,559 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00501826 · 160 participants · Phase 2
Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
- NCT00932139 · 160 participants · NA
Effect of Electro-Acupuncture on Blood Pressure
- NCT00992901 · 160 participants · Early Phase 1
Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery
- NCT01515527 · 160 participants · Phase 2
Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia