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

NCT06570460 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-08-26

No results posted yet for this study

Summary

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.

Conditions

  • Turner Syndrome
  • Hypogonadism; Ovarian
  • Hormone Replacement Therapy
  • Estrogen Replacement Therapy
  • Estrogen Deficiency

Interventions

DRUG

17-beta estradiol

Treatment with orally administered estrogen for 6 months

DRUG

17-beta estradiol

Treatment with transdermally administered estrogen for 6 months

Sponsors & Collaborators

  • University of Aarhus

    collaborator OTHER

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Claus H Gravholt, Professor · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06570460 on ClinicalTrials.gov