EUCTR2008-002599-86-GB进行中（未招募）不适用
A prospective open randomised controlled trial of women diagnosed with premature ovarian failure (POF) to investigate the effects of active treatment with HRT (hormone replacement therapy) or COCP (combined oral contraceptive pill), 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 2 years. - Treatment of Premature Ovarian Failure
Guy's and St Thomas Foundation NHS Trust0 个研究点目标入组 66 人开始时间: 2009年4月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Age 18-45 years
- •Women with a diagnosis of POF within the last 36 months (with documented FSH level >30IU on 2 occassions 4-8 weeks apart)
- •Ability to understand English
- •Written informed consent for participation in the trial
- •Not taking hormone medication (HRT/COCP/’natural’ preparations) for 2 months prior to commencement in the trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
- •Age 18-45 years
- •Women with a diagnosis of POF within the last 36 months (with documented FSH level >30IU on 2 occassions 4-8 weeks apart)
- •Ability to understand English
- •Written informed consent for participation in the trial
- •Not taking hormone medication (HRT/COCP/’natural’ preparations) for 2 months prior to commencement in the trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Age less than 18 or over 45 years
- •Current desire for pregnancy is an exclusion criteria 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.
- •Women with absolute contraindications to hormone treatment will be excluded from the active treatment group (ie. personal history of thromboembolic disease, oestrogen dependent malignancies, personal history of focal migraine).
- •Women taking medication for high cholesterol or found to have raised cholesterol levels on initial assessment.
- •Untreated thyroid disease
- •Age less than 18 or over 45 years
- •Current desire for pregnancy is an exclusion criteria 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.
- •Women with absolute contraindications to hormone treatment will be excluded from the active treatment group (ie. personal history of thromboembolic disease, oestrogen dependent malignancies, personal history of focal migraine).
- •Women taking medication for high cholesterol or found to have raised cholesterol levels on initial assessment.
- •Untreated thyroid disease
研究者
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