Quantitative Liver Functions in Turner Syndrome With and Without Hormone Replacement Therapy

NCT00825617 | Completed DMC

• 1 other identifier: 19963561
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Several studies have demonstrated that Turner Syndrome patients have elevated liver enzymes readily suppressible by a short course of HRT. We wanted to estimated quantitative liver functions in a young group of Turner syndrome patients compared to a healthy control group.

Conditions

Turner Syndrome

Keywords

TS; HRT; Liver function tests

Outcome Measures

Primary Outcomes (1)

• quantitative liver function tests

  1996-1999

Study Arms (1)

HRT

EXPERIMENTAL

Women with TS were treated with oral hormone substitution consisting of 2 mg 17β-estradiol/day for days 1-12, 2 mg 17β-estradiol/day and 1 mg norethisterone acetate/day for days 13-22 and 1 mg 17β-estradiol/day for days 23-28 (Trisekvens, Novo Nordisk A/S, Bagsværd, Denmark)

Drug: Hormone replacement therapy

Interventions

Hormone replacement therapy DRUG

Women with TS were treated with oral hormone substitution consisting of 2 mg 17β-estradiol/day for days 1-12, 2 mg 17β-estradiol/day and 1 mg norethisterone acetate/day for days 13-22 and 1 mg 17β-estradiol/day for days 23-28 (Trisekvens, Novo Nordisk A/S, Bagsværd, Denmark)

Also known as: Trisekvens, Novo Nordisk A/S, Bagsværd, Denmark

HRT

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Turner syndrome by karyotype

You may not qualify if:

• Thyroid abnormality
• Glucocorticoid treatment

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Medical department M and Investigational Laboratories

Aarhus C, Jutland, 8000, Denmark

Location

MeSH Terms

Conditions

Turner Syndrome

Interventions

Hormone Replacement Therapy; Trisequens

Condition Hierarchy (Ancestors)

Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• J S Christíansen, Professor

  Medical departmnet M, Aarhus University Hospital, NBG, Denamrk,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 21, 2009
• Study Start: October 1, 1996
• Primary Completion: October 1, 1999
• Study Completion: June 1, 2000
• Last Updated: January 21, 2009

Record last verified: 2009-01

Locations

DK (1)