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 个研究点目标入组 66 人开始时间: 2009年1月26日最近更新: 2018年9月10日

适应症

试验速览

•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

•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

发起方

King's College London (UK)