Clinical Trials Logo

Clinical Trial Summary

The study attempts to evaluate if the way of administering estrogen, the principal female hormone, via patches or orally, affects the way estrogen works in girls with Turner Syndrome. These are girls who are very short and whose ovaries do not work. We will examine changes bone, protein and fat metabolism under the influence of estrogen delivered by a patch trough the skin vs estrogen taken orally. These studies are conducted while the girls are taking GH therapy.


Clinical Trial Description

Girls with Turner Syndrome, between the ages of 10-16 years, were chosen as the study population. The study requires 3 overnight admissions to an in-patient Clinical Research Center(CRC). A baseline study is performed using stable isotope tracers of leucine, glycerol and glucose and serial blood sampling to measure protein and fat metabolism. Indirect calorimetry is used to measure substrate oxidation rates and total energy expenditure. DEXA scan is used to measure bone mineral density and body composition. Once the baseline study is complete subjects are randomly assigned to receive either estrogen orally or through a patch placed onto the skin in increasing doses changed every 2 weeks. After 6 weeks of estrogen treatment a second metabolic study, identical to the first, is performed, followed by a wash out period of 4 weeks. Subsequently, the subjects are switched to the alternate form of estrogen. At the end of 6 weeks a third and final metabolic study is repeated. All subjects continue to be on growth hormone throughout the study procedures. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00140998
Study type Interventional
Source Nemours Children's Clinic
Contact
Status Completed
Phase Phase 3
Start date January 2001
Completion date June 2004

See also
  Status Clinical Trial Phase
Completed NCT03126656 - Effects of Testosterone on Myocardial Repolarization Phase 4
Terminated NCT02419105 - Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors Phase 3
Withdrawn NCT02137265 - Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism N/A
Completed NCT02222558 - Oral Testosterone for the Treatment of Hypogonadism in Males Phase 2
Completed NCT02233751 - Pharmacokinetic Study of Subcutaneous Testosterone Enanthate Phase 1
Completed NCT01887418 - Pharmacokinetic Study of Testosterone Enanthate Phase 1/Phase 2
Terminated NCT01092858 - NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH) Phase 4
Completed NCT00624624 - Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism N/A
Completed NCT00752869 - Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement Phase 4
Completed NCT00613288 - Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism N/A
Completed NCT00838838 - Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis N/A
Completed NCT00119483 - Older Men and Testosterone N/A
Completed NCT00004438 - Leuprolide in Treating Adults With Hypogonadotropism N/A
Withdrawn NCT00398034 - Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study. Phase 2
Completed NCT02921386 - The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate Phase 2
Completed NCT02937740 - Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natestoâ„¢ Phase 4
Completed NCT01717768 - Oral Testosterone for the Treatment of Hypogonadism Phase 2
Terminated NCT01460654 - Testosterone and Alendronate in Hypogonadal Men Phase 2
Completed NCT00998933 - Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure Phase 1
Completed NCT00857454 - A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations Phase 3