Hormone Replacement Therapy to Treat Turner Syndrome
Turner Syndrome: Hormone Replacement Therapy
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
A PHASE2 clinical study on Osteoporosis and Turner's Syndrome, this trial is completed. The trial is conducted by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and has accumulated 6 data snapshots since 2001. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)Turner Syndrome (TS) is characterized by ovarian dysgenesis and short stature resulting from the partial or complete deletion of one X-chromosome. Adults with TS have excessive rates of osteoporosis, hypertension, dyslipidemia and diabetes mellitus and may have increased morbidity and mortality as a result. These problems of adults with TS may be secondary to deficiency of ovarian hormones or may result from halpo-insufficiency for as yet unknown X-chromosome genes. There have been no prospective, controlled studies of the effects of hormone replacement therapy (HRT) in TS, but available data suggest that conventional oral HRT designed for postmenopausal women may not prevent osteoporosis and may aggravate hypertension in this disorder. Of note, girls and women with TS are deficient in ovarian androgens as well as estrogen, and have reduced muscle mass, which may contribute to osteoporosis and insulin resistance. In addition, reduced androgens may contribute to the impairment of self esteem and social interactions suffered by many with TS. In this study, two different hormone regimens for TS will be compared in a randomized, placebo-controlled, double-blind design. Both groups will receive transdermal estradiol (E2, 100 mcg/day) with cyclic progesterone; one group will receive a physiological dose of testosterone (T) by transdermal...
Turner Syndrome (TS) is characterized by ovarian dysgenesis and short stature resulting from the partial or complete deletion of one X-chromosome. Adults with TS have excessive rates of osteoporosis, hypertension, dyslipidemia and diabetes mellitus and may have increased morbidity and mortality as a result. These problems of adults with TS may be secondary to deficiency of ovarian hormones or may result from halpo-insufficiency for as yet unknown X-chromosome genes. There have been no prospective, controlled studies of the effects of hormone replacement therapy (HRT) in TS, but available data suggest that conventional oral HRT designed for postmenopausal women may not prevent osteoporosis and may aggravate hypertension in this disorder. Of note, girls and women with TS are deficient in ovarian androgens as well as estrogen, and have reduced muscle mass, which may contribute to osteoporosis and insulin resistance. In addition, reduced androgens may contribute to the impairment of self esteem and social interactions suffered by many with TS. In this study, two different hormone regimens for TS will be compared in a randomized, placebo-controlled, double-blind design. Both groups will receive transdermal estradiol (E2, 100 mcg/day) with cyclic progesterone; one group will receive a physiological dose of testosterone (T) by transdermal patch while the other group will receive a placebo patch. The treatment duration is 2 years. Major outcome parameters include predicted improvements in bone mineral density, body composition and psychosocial well-being. Essential information will be collected on the effects of hormone treatments on insulin sensitivity and blood pressure in TS. This study will help to optimize hormone replacement treatment for women with TS, and to clarify which of the metabolic problems of TS are secondary to ovarian hormone deficiency, and which are due to genetic factors.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
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Sep 2024 — Present [monthly]
Completed PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE2
First recorded
Mar 2001
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
For direct contact, visit the study record on ClinicalTrials.gov .