ISRCTN91141124进行中（未招募）3 期
Premature Ovarian Insufficiency Study of Effectiveness of hormonal therapy
niversity College London0 个研究点目标入组 480 人开始时间: 2021年9月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 480
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 03/01/2024:
- •1. Diagnosis of POI (based on NICE guidelines) or with an established diagnosis of POI (e.g. Turner Syndrome, surgical menopause)
- •2. Will be aged older than 18 and less than 40 years at randomisation
- •3. Not intending to become pregnant within 12 months
- •4. Not taken any HRT, COC or testosterone treatment for the last 4 weeks or willing to stop HRT/COC/testosterone treatment for a minimum period of 4 weeks prior to randomisation
- •5. Must provide written/electronic informed consent
- •Previous inclusion criteria:
- •1. Diagnosis of POI
- •2. Will be aged older than 18 and less than 40 years at randomisation
- •3. Not intending to become pregnant within 12 months
- •4. Not taken any HRT or COC treatment for the last 4 weeks or willing to stop HRT/COC treatment for a minimum period of 4 weeks prior to randomisation
- •5. Must provide written/electronic informed consent
排除标准
- •Current exclusion criteria as of 03/01/2024:
- •1. Contraindications to HRT or COC
- •2. Taking other drugs affecting BMD e.g. bisphosphonates and long-term use of systemic corticosteroids (dietary supplements e.g. Vitamin D, calcium and short course of corticosteroids are permitted)
- •3. Receiving estrogens for puberty induction
- •4. Participation in a clinical research study (currently or in the last 3 months) involving testosterone treatments or novel HRT formulations
- •Previous exclusion criteria:
- •1. Contraindications to HRT or COC
- •2. Taking other drugs affecting BMD e.g. bisphosphonates and long-term use of systemic corticosteroids (dietary supplements e.g. Vitamin D, calcium and short course of corticosteroids are permitted)
- •3. Receiving sex steroid hormones for puberty induction
- •4. Participation in a clinical research study (currently or in the last 3 months) involving testosterone treatments or novel HRT formulations
研究者
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