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

Condition(s) studied

Investigational drug(s) / intervention(s)

17-beta estradiol: Treatment with orally administered estrogen for 6 months

17-beta estradiol: Treatment with transdermally administered estrogen for 6 months

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.

Eligibility

Primary outcome measure(s)

• Blood test values — After 1 month of wash-out, 6 months of oral and six months of transdermal treatment
  Changes in blood test values of follicle stimulating hormone and luthenizing hormone from baseline
• Blood test values — After 1 month of wash-out, 6 months of oral and six months of transdermal treatment
  Changes in blood test values of estradiol from baseline
• Dual energy X-ray absorptiometry — After 6 months of oral and six months of transdermal treatment
  Changes in body composition and bone mineral density
• Cardiovascular status — After 6 months of oral and six months of transdermal treatment
  Changes in 24-hour blood pressure measurements
• Cardiovascular status — After 6 months of oral and six months of transdermal treatment
  Changes in arterial stiffness measured by SphygmoCor
• Muscle quality (quadriceps femoris) — After 6 months of oral and six months of transdermal treatment
  MR scan of both quadriceps measuring muscle cross-sectional area (CSA) and fat content of the muscle. Maximal isometric muscle strength of both quadriceps (functional muscle tests). Muscle quality = maximum quadriceps strength measured in nM/muscle CSA.
• Functional muscle tests — After 6 months of oral and six months of transdermal treatment
  Changes in maximal jumping height
• Isometric muscle tests — After 6 months of oral and six months of transdermal treatment
  Changes in maximal isometric hand strength
• Maximal oxygen uptake test (VO2 max) — After 6 months of oral and six months of transdermal treatment
  Changes in maximal oxygen uptake

Trial sites (1)

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