Long Term Effects of Oral Versus Transdermal Estrogen Replacement Therapy in Turner Syndrome

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorAarhus University Hospital

About this trial

This 14-month, phase IV, randomized controlled crossover trial aims to compare the effects of oral versus transdermal estrogen replacement therapy (ERT) in women with Turner syndrome (TS). The study's objectives are to clarify endocrine, metabolic, cardiovascular, and thromboembolic risk factors in TS after a wash-out period without estrogen (E2) treatment; compare the effects of oral versus transdermal (TD) ERT regimens; and examine the long-term effects of E2 administration via these two routes. The study involves 50 TS women aged 18-50 years and 50 control participants. TS participants are randomized to receive either oral or TD ERT for six months, followed by crossover to the alternate treatment for another six months. Prior to randomization, any existing ERT will be discontinued for a 1-month washout period. A second 1-month washout period will occur between the two 6-month treatment phases. Laboratory analyses and clinical investigations are performed after the first wash-out period, after the first six months of treatment, and after the last six months of treatment. We anticipate that this study may provide a basis for new and improved recommendations for sex hormone replacement therapy in TS.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosis of TS regardless of karyotype

Age 18-50 years

Already receiving estrogen treatment

Female

Disqualifiers

Active systemic chronic diseases

Known or suspected breast cancer

Known or suspected estradiol-dependent tumors (endometrial cancer or similar)

Untreated endometrial hyperplasia

Trial design

Design model

Crossover

Treatments tested in this trial

  • 17-beta estradiol

    Drug

    Treatment with orally administered estrogen for 6 months

  • 17-beta estradiol

    Drug

    Treatment with transdermally administered estrogen for 6 months

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Oral estrogen treatmentActive comparator 1 intervention
Group B: Transdermal estrogen treatmentActive comparator 1 intervention
Group C: ControlsNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Blood test values

Changes in blood test values of follicle stimulating hormone and luthenizing hormone from baseline

Time frame
After 1 month of wash-out, 6 months of oral and six months of transdermal treatment
2

Blood test values

Changes in blood test values of estradiol from baseline

Time frame
After 1 month of wash-out, 6 months of oral and six months of transdermal treatment
3

Dual energy X-ray absorptiometry

Changes in body composition and bone mineral density

Time frame
After 6 months of oral and six months of transdermal treatment
4

Cardiovascular status

Changes in 24-hour blood pressure measurements

Time frame
After 6 months of oral and six months of transdermal treatment

Secondary outcomes

1

Self-reported health-related quality of life and functioning (SF-36)

The Short Form 36 Health Survey is a self-reported quality of life questionnaire consisting of eight scaled scores. Each scale is transformed directly into a 0-100 scale, where a lower score indicates greater difficulty.

Time frame
After 6 months of oral and six months of transdermal treatment
2

Self-reported quality of life (WHOQoL-Bref)

The WHOQoL-Bref is a questionnaire where the participant's answers to 26 questions are used to create an overall quality of life profile. This profile includes scores for each dimension of the questionnaire: physical health, mental health, social relationships, and the participant's environment.

Time frame
After 6 months of oral and six months of transdermal treatment
3

Subjective medication assesment

Subjective assesment of the medication after 6 months of use

Time frame
After 6 months of oral and six months of transdermal treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aarhus University Hospital

Lead sponsor

University of Aarhus

Collaborator