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

U

University of Edinburgh

Status and phase

Completed
Phase 4

Conditions

Premature Ovarian Failure

Treatments

Drug: Ethinylestradiol / Norethisterone
Drug: Estradiol / Progesterone

Study type

Interventional

Funder types

Other

Identifiers

NCT00732693
CLIC/Sargent-178000-R35464

Details and patient eligibility

About

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.

Full description

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.

Enrollment

42 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Premature Ovarian Failure

Exclusion criteria

  • Intercurrent illness

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

42 participants in 2 patient groups

1
Experimental group
Description:
Treatment with standard sex steroid replacement regimen
Treatment:
Drug: Ethinylestradiol / Norethisterone
2
Experimental group
Description:
Treatment with physiologic sex steroid regimen
Treatment:
Drug: Estradiol / Progesterone

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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