Defining the Optimal Hormonal Replacement Therapy in Turner Syndrome

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00134745
First received: August 24, 2005
Last updated: June 13, 2013
Last verified: June 2013

August 24, 2005
June 13, 2013
June 2005
March 2013   (final data collection date for primary outcome measure)
  • The size of the uterus evaluated by magnetic resonance (MR)-scan [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Bones evaluated by dual-energy X-ray absorptiometry (DEXA)-scan [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • The size of the uterus evaluated by MR-scan
  • Bones evaluated by DEXA-scan
Complete list of historical versions of study NCT00134745 on ClinicalTrials.gov Archive Site
  • The diameter of the aortic root evaluated by MR-scan [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Development of biochemical markers [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Body composition evaluated by DEXA-scan [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Emotional wellbeing and self-esteem evaluated by questionnaires [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • The size of the uterus evaluated by ultrasound [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • The diameter of the aortic root evaluated by MR-scan
  • Development of biochemical markers
  • Body composition evaluated by DEXA-scan
  • Emotional wellbeing and self-esteem evaluated by questionnaires
  • The size of the uterus evaluated by ultrasound
Not Provided
Not Provided
 
Defining the Optimal Hormonal Replacement Therapy in Turner Syndrome
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Turner Syndrome
Drug: estradiol
tablets, 2 mg day 1 through day 22 of the menstrual cycle for 5 years
  • Active Comparator: 4 mg estradiol
    Intervention: Drug: estradiol
  • Placebo Comparator: 2 mg estradiol
    Intervention: Drug: estradiol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Female
10 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00134745
120895
Yes
Line Cleemann, Hillerod Hospital, Denmark
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
Principal Investigator: Line Cleemann, Doctor Pediatric Unit, Hillerod Hospital
Hillerod Hospital, Denmark
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP