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Sponsored by: |
University of Edinburgh |
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Information provided by: | University of Edinburgh |
ClinicalTrials.gov Identifier: | NCT00732693 |
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.
Condition | Intervention | Phase |
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Premature Ovarian Failure |
Drug: Ethinylestradiol / Norethisterone Drug: Estradiol / Progesterone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study |
Official Title: | Comparison of Standard and Physiologic Sex Steroid Replacement Regimens in Women With Premature Ovarian Failure and the Assessment of Skeletal, Cardiovascular and Reproductive Parameters |
Enrollment: | 42 |
Study Start Date: | February 2002 |
Study Completion Date: | November 2006 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Treatment with standard sex steroid replacement regimen
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Drug: Ethinylestradiol / Norethisterone
Oral ethinylestradiol 30mcg and norethisterone 1.5mg daily for weeks 1-3, followed by 7 "pill free" days
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2: Experimental
Treatment with physiologic sex steroid regimen
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Drug: Estradiol / Progesterone
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
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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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Royal Hospital for Sick Children | |
Edinburgh, United Kingdom, EH9 1LF | |
Royal Infirmary of Edinburgh | |
Edinburgh, United Kingdom, EH16 4SA |
Principal Investigator: | W Hamish B Wallace, MD | NHS Lothian / University of Edinburgh |
Responsible Party: | NHS Lothian / University of Edinburgh ( Dr W Hamish B Wallace, Consultant/Reader in Paediatric Oncology ) |
Study ID Numbers: | CLIC/Sargent-178000-R35464 |
Study First Received: | August 11, 2008 |
Last Updated: | August 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00732693 History of Changes |
Health Authority: | United Kingdom: National Health Service; United Kingdom: Research Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Premature ovarian failure Sex hormone replacement HRT Blood pressure |
Bone mineral density Bone metabolism Uterine function |
Modicon Progesterone Gonadal Disorders Contraceptive Agents Hormone Antagonists Estradiol valerate Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Estradiol 17 beta-cypionate Ovarian Diseases Hormones Genital Diseases, Female |
Norethindrone Estradiol 3-benzoate Progestins Polyestradiol phosphate Estrogens Endocrine System Diseases Ethinyl Estradiol Ovarian Failure, Premature Norinyl Estradiol Endocrinopathy Norethindrone acetate |
Estrogens Progesterone Contraceptive Agents Gonadal Disorders Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Ethinyl Estradiol Ovarian Failure, Premature Reproductive Control Agents |
Ovarian Diseases Hormones Pharmacologic Actions Estradiol Adnexal Diseases Genital Diseases, Female Norethindrone Progestins Therapeutic Uses Contraceptives, Oral, Synthetic Norethindrone acetate |