NCT00134745

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2005

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

June 14, 2013

Status Verified

June 1, 2013

Enrollment Period

7.8 years

First QC Date

August 24, 2005

Last Update Submit

June 13, 2013

Conditions

Turner Syndrome

Keywords

Turner SyndromeHormonal replacement therapyBone mineralizationUterine sizeaortic root dilatation

Outcome Measures

Primary Outcomes (2)

  • The size of the uterus evaluated by magnetic resonance (MR)-scan

    5 years

  • Bones evaluated by dual-energy X-ray absorptiometry (DEXA)-scan

    5 years

Secondary Outcomes (5)

  • The diameter of the aortic root evaluated by MR-scan

    5 years

  • Development of biochemical markers

    5 years

  • Body composition evaluated by DEXA-scan

    5 years

  • Emotional wellbeing and self-esteem evaluated by questionnaires

    5 years

  • The size of the uterus evaluated by ultrasound

    5 years

Study Arms (2)

4 mg estradiol

ACTIVE COMPARATOR
Drug: estradiol

2 mg estradiol

PLACEBO COMPARATOR
Drug: estradiol

Interventions

estradiolDRUG

tablets, 2 mg day 1 through day 22 of the menstrual cycle for 5 years

2 mg estradiol4 mg estradiol

Eligibility Criteria

Age10 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Verified Turner syndrome
  • Ages 10-25 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Unit, Hillerod Hospital

Hillerød, Frederiksborg County, 4300, Denmark

Location

Related Publications (2)

  • Cleemann L, Holm K, Fallentin E, Moller N, Kristensen B, Skouby SO, Leth-Esbensen P, Jeppesen EM, Jensen AK, Gravholt CH. Effect of Dosage of 17ss-Estradiol on Uterine Growth in Turner Syndrome-A Randomized Controlled Clinical Pilot Trial. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz061. doi: 10.1210/clinem/dgz061.

    PMID: 31613320DERIVED

  • Brun S, Cleemann L, Holm K, Salskov G, Erlandsen M, Berglund A, Andersen NH, Gravholt CH. Five-Year Randomized Study Demonstrates Blood Pressure Increases in Young Women With Turner Syndrome Regardless of Estradiol Dose. Hypertension. 2019 Jan;73(1):242-248. doi: 10.1161/HYPERTENSIONAHA.118.11742.

    PMID: 30571546DERIVED

MeSH Terms

Conditions

Turner Syndrome

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Gonadal DysgenesisDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSex Chromosome Disorders of Sex DevelopmentMale Urogenital DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSex Chromosome DisordersChromosome DisordersGenetic Diseases, InbornGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Line Cleemann, Doctor

    Pediatric Unit, Hillerod Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor, PhD

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 25, 2005

Study Start

June 1, 2005

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

June 14, 2013

Record last verified: 2013-06

Locations

DK(1)