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Completed

NCT Number: NCT00732693

Evaluation of Physiologic and Standard Sex Steroid Replacement Regimens in Women With Premature Ovarian Failure

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.

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Key information

Conditions

Premature Ovarian Failure Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Primary Ovarian Insufficiency Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Royal Hospital for Sick Children, Edinburgh, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premature Ovarian Failure

Exclusion criteria

  • Intercurrent illness

Treatment and study plan

Ethinylestradiol / Norethisterone

Drug

Oral ethinylestradiol 30mcg and norethisterone 1.5mg daily for weeks 1-3, followed by 7 "pill free" days

Other names: Loestrin 30, Galen Ltd, UK

Estradiol / Progesterone

Drug

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

Other names: Estraderm TTS, Novartis Pharmaceuticals UK Ltd, Cyclogest, Activis UK Ltd

Primary outcomes

  1. Change in 24 hour ambulatory blood pressure

    Time frame: Before each washout period, then at 0, 3, 6 and 12 months of each treatment

  2. Bone mineral density measurements (DEXA)

    Time frame: Baseline, 14 and 24 months

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Aug 12, 2008
Registry last updated
Aug 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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