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Defining the Optimal Hormonal Replacement Therapy in Turner Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00134745
First Posted: August 25, 2005
Last Update Posted: June 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Novo Nordisk A/S
The County of Frederiksborg
The foundation of Kaptajnløjtnant Harald Jensen and Wife
The foundation of Mrs. Olga Bryde
The foundation of Mr. Ivan Nielsen
Information provided by (Responsible Party):
Line Cleemann, Hillerod Hospital, Denmark
  Purpose

The purpose of this study is to examine whether a larger dosage of estrogen than the one used today will secure the development of a normal sized uterus and increase the strength of the bones in girls and young women with Turner syndrome.

The purpose is also to evaluate whether aortic dilatation is present in this group of patients, and if the estrogen dosage will influence the emotional well-being and self-esteem of the patients.


Condition Intervention Phase
Turner Syndrome Drug: estradiol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Growth of Genitalia Interna and the Bone Mineralization Under Hormonal Replacement Therapy and the Presence of Aortic Root Dilatation in Girls With Turner Syndrome

Resource links provided by NLM:


Further study details as provided by Line Cleemann, Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • The size of the uterus evaluated by magnetic resonance (MR)-scan [ Time Frame: 5 years ]
  • Bones evaluated by dual-energy X-ray absorptiometry (DEXA)-scan [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • The diameter of the aortic root evaluated by MR-scan [ Time Frame: 5 years ]
  • Development of biochemical markers [ Time Frame: 5 years ]
  • Body composition evaluated by DEXA-scan [ Time Frame: 5 years ]
  • Emotional wellbeing and self-esteem evaluated by questionnaires [ Time Frame: 5 years ]
  • The size of the uterus evaluated by ultrasound [ Time Frame: 5 years ]

Enrollment: 43
Study Start Date: June 2005
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 4 mg estradiol Drug: estradiol
tablets, 2 mg day 1 through day 22 of the menstrual cycle for 5 years
Placebo Comparator: 2 mg estradiol Drug: estradiol
tablets, 2 mg day 1 through day 22 of the menstrual cycle for 5 years

Detailed Description:

Turner syndrome is a common chromosomal disorder with only one X-chromosome or partial deletions in one X-chromosome in all or some of the cell-lines in the body. Appr. 18 girls/year are being born with the syndrome in Denmark. The syndrome is mostly known for reduced final height and the lack of pubertal development with infertility, but it is also known for diseases influencing other parts of the body like the heart with the risk of development of aortic dilatation and subsequently dissection with the risk of rupture, profuse bleeding and sudden death. Reduced bone strength and increased risk of bone fracture are also features of the syndrome. Treatment with growth hormone and female sex-hormones are well-established treatments.

Girls and young women with Turner syndrome ages 10 to 21 years will participate. The girls ages 15 to 21 years will randomly and double blindly receive treatment with either 2 mg or 4 mg estrogen for 5 years. Yearly examinations with blood tests, physical examinations, questionnaires, ultrasound and MR-scan of the internal female genitalia, DEXA-scan of the bones and MR-scan of the heart will be performed.

  Eligibility

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Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Verified Turner syndrome
  • Ages 10-25 years

Exclusion Criteria:

  • Contraindications to the MR-scan
  • Contraindications to the trial medication
  • Severe or chronic sickness with impact on the parameters of the study or incompatibility with the trial medication
  • Intake of medications with interactions with trial medication
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134745


Locations
Denmark
Pediatric Unit, Hillerod Hospital
Hillerod, Frederiksborg County, Denmark, 4300
Sponsors and Collaborators
Line Cleemann
Novo Nordisk A/S
The County of Frederiksborg
The foundation of Kaptajnløjtnant Harald Jensen and Wife
The foundation of Mrs. Olga Bryde
The foundation of Mr. Ivan Nielsen
Investigators
Principal Investigator: Line Cleemann, Doctor Pediatric Unit, Hillerod Hospital
  More Information

Responsible Party: Line Cleemann, Doctor, PhD, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier: NCT00134745     History of Changes
Other Study ID Numbers: 120895
First Submitted: August 24, 2005
First Posted: August 25, 2005
Last Update Posted: June 14, 2013
Last Verified: June 2013

Keywords provided by Line Cleemann, Hillerod Hospital, Denmark:
Turner Syndrome
Hormonal replacement therapy
Bone mineralization
Uterine size
aortic root dilatation

Additional relevant MeSH terms:
Syndrome
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Disease
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists