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

Launched by AARHUS UNIVERSITY HOSPITAL · Aug 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the long-term effects of two different ways of taking estrogen replacement therapy (ERT) in women with Turner syndrome (TS), a condition that affects how a woman’s body develops. The trial will compare oral estrogen, which is taken as a pill, to transdermal estrogen, which is applied to the skin as a patch. The goal is to understand how each method affects hormone levels, heart health, and other important factors over a period of 14 months. The study involves 50 women with TS aged 18 to 50, who will receive one type of treatment for six months, then switch to the other type for another six months after a short break without treatment.

To be eligible for this trial, women with Turner syndrome must already be receiving estrogen treatment and be between 18 and 50 years old. Healthy women who do not have any health issues and are not taking any medications may also participate as a comparison group. Participants can expect to go through several health assessments during the study to monitor the effects of the treatments. This research could help develop better recommendations for hormone therapy in women with Turner syndrome in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion criteria:
• For participants with TS:
• • Diagnosis of TS regardless of karyotype
• • Age 18-50 years
• • Already receiving estrogen treatment
• For healthy controls:
• • Female
• • Age 18-50 years
• • Previously healthy
• • Not receiving any medication
• • Not using any form of contraceptive pills
• • No mental or psychiatric disorders
• Exclusion criteria:
• • Active systemic chronic diseases
• • Known or suspected breast cancer
• • Known or suspected estradiol-dependent tumors (endometrial cancer or similar)
• • Untreated endometrial hyperplasia
• • Current or previous venous thromboembolism
• • Acute or previous liver disease where liver enzymes are still elevated by a factor 3 or more
• • Known hypersensitivity to the medications used
• • Pregnancy
• • Menopause (for the control group only)