A Phase 4 interventional study of Ethinylestradiol / Norethisterone and Estradiol / Progesterone in Premature Ovarian Failure, sponsored by University of Edinburgh. Completed at 2 sites in United Kingdom. Open to female participants. Per ClinicalTrials.gov, last updated 2008-08-12.
Sponsored by University of Edinburgh · Phase 4, Interventional, and Treatment
The aim of the study is to determine whether physiological sex steroid replacement improves parameters of skeletal, cardiovascular and reproductive health of women treated with current sex steroid replacement regimens.
Premature ovarian failure, defined as the onset of the menopause before the age of 40 years, is a relatively common problem that affects 1% of women. There are a variety of aetiologies underlying premature ovarian failure including Turner syndrome and those with idiopathic onset, however with the increasing success of intensive treatment for childhood cancer, there are increasing numbers of young survivors, with a variety of late effects of treatment, including premature ovarian failure.
Evidence is required for the optimal management of young women with premature ovarian failure, either as a result of childhood cancer treatment or for other reasons. These women are currently offered combined sex steroid replacement in the convenient form of the oral contraceptive pill, or hormone replacement therapy, designed for older women after the menopause. These preparations are not designed to achieve physiological replacement of oestrogen or progesterone, either in dosage or in biochemical structure - many preparations using synthetic derivatives. These younger women who have differing metabolic and psychological requirements are looking to a future of 30 or more years of replacement. The optimal mode of SSR is not known for young women with premature ovarian failure, however there is concern that current regimens may be inadequate for optimal skeletal and cardiovascular health.
Current preliminary data demonstrates that use of physiological sex steroid replacement improves uterine parameters. Evidence is required to determine whether optimising sex steroid replacement can also significantly improve parameters of skeletal and cardiovascular health. Young women with ovarian failure face several decades of hormone replacement, so small improvements in management may make large differences to later morbidity and mortality.
The aim of the study is to determine whether physiological sex steroid replacement improves parameters of skeletal, cardiovascular and reproductive health of women treated with current sex steroid replacement regimens.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 42 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University of Edinburgh is the lead sponsor of 393 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with standard sex steroid replacement regimen
Drug: Ethinylestradiol / Norethisterone
Treatment with physiologic sex steroid regimen
Drug: Estradiol / Progesterone
Oral ethinylestradiol 30mcg and norethisterone 1.5mg daily for weeks 1-3, followed by 7 "pill free" days
Also known as: Loestrin 30, Galen Ltd, UK
Transdermal estradiol 100mcg daily for week 1, then 150mcg daily for weeks 2-4; and vaginal progesterone pessaries 200mg twice daily for weeks 3-4
Also known as: Estraderm TTS, Novartis Pharmaceuticals UK Ltd, Cyclogest, Activis UK Ltd
Change in 24 hour ambulatory blood pressure
Time frame: Before each washout period, then at 0, 3, 6 and 12 months of each treatment
Bone mineral density measurements (DEXA)
Time frame: Baseline, 14 and 24 months
Uterine ultrasound scan to assess uterine volume, endometrial thickness, and uterine artery blood flow
Time frame: Before each washout period, then at 0, 3, 6 and 12 months of each treatment
Central arterial blood pressure and arterial stiffness measured using peripheral arterial tonometry
Time frame: Before each washout period, then at 0, 3, 6 and 12 months of each treatment phase
Biochemical evidence of activity on the renin-angiotensin system, including plasma renin activity, angiotensin II, aldosterone, creatinine, urea and electrolyte concentrations.
Time frame: Before each washout period, then at 0, 3, 6 and 12 months of each treatment phase
Serum markers of collagen turnover and bone matrix formation
Time frame: Before each washout period, then at 0, 3, 6 and 12 months of each treatment phase
Hormonal assays for gonadotrophins, FSH, LH and sex steroids estrogen and progesterone
Time frame: Before each washout period, then at 0, 3, 6 and 12 months of each treatment phase
This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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University of Edinburgh