Estrogen Treatment (Oral vs. Patches) in Turner Syndrome

Hypogonadism Clinical Trial

Official title:

Estrogen Replacement in Hypogonadal Girls Treated With GH: Differential Effects of Mode of Estrogen Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00140998
• Other study ID #: 00-136
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2005
• Last updated: November 28, 2017
• Start date: January 2001
• Est. completion date: June 2004

Study information

• Verified date: August 2017
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 16 Years

Eligibility

Inclusion Criteria:Girls with Turner syndrome 10-16 years old who are receiving growth hormone treatment.

Exclusion Criteria:Systemic disease or concomitant treatment wtih Oxandrolone. Significant obesity or chronic steroid use.

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Hypogonadism
• Menopause, Premature
• Premature Ovarian Failure
• Primary Ovarian Insufficiency
• Syndrome
• Turner Syndrome

Intervention

Drug:
• 17 beta estradiol

Locations

Country	Name	City	State
United States	Nemours Children's Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nemours Children's Clinic	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Composition
Primary	Rates of whole body protein kinetics
Primary	Rates of whole body lipolysis
Secondary	Changes in IGF-I concentrations
Secondary	Changes in Plasma Lipids