ISRCTN87011615
Completed
未知
A prospective open randomised controlled trial of women diagnosed with premature ovarian failure (POF) to investigate the effects of active treatment with hormone replacement therapy (HRT) or combined oral contraceptive pill (COCP), and observation of patients who choose to have no treatment, on bone density, markers of cardiovascular disease, markers of bone metabolism, menopausal symptoms, quality of life, depression score, sexual function and ovarian function over two years
King's College London (UK)0 sites66 target enrollmentJanuary 26, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Premature ovarian failure
- Sponsor
- King's College London (UK)
- Enrollment
- 66
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
- 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20424282 2. 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27340881
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age 18\-44 years
- •2\. Women with a diagnosis of premature ovarian failure (POF) within the last 36 months (with documented follicle\-stimulating hormone \[FSH] level \>30 IU on 2 occasions 4\-8 weeks apart)
- •3\. Ability to understand English
- •4\. Written informed consent for participation in the trial
- •5\. Not taking hormone medication (HRT/COCP/natural preparations) for 2 months prior to commencement in the trial
Exclusion Criteria
- •1\. Age less than 18 or over 45 years
- •2\. Current desire for pregnancy is an exclusion criterion from the active treatment group (as she may be randomised to take COCP). However, she could elect to take part in the no treatment group.
- •3\. Women with absolute contraindications to hormone treatment will be excluded from the active treatment group (i.e. personal history of thromboembolic disease, oestrogen dependent malignancies, and personal history of focal migraine)
- •4\. Women taking medication for high cholesterol or found to have raised cholesterol levels on initial assessment
- •5\. Untreated thyroid disease
Outcomes
Primary Outcomes
Not specified
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