NL-OMON53396招募中4 期
The effect of low-dose rhythmic 17-β-estradiol administration on bone turnover in postmenopausal women - REBE
Amsterdam UMC0 个研究点目标入组 48 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
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
- 年龄范围
- 18 至 64（—）
入选标准
- •- Postmenopausal, defined as final menstrual cycle more than 12 months prior to
- •inclusion and FSH>30 IU/L
- •- Final menstrual cycle < 10 years prior to inclusion
- •- Age 45-60 years
排除标准
- •Contra-indication for estrogen and/or progesterone therapy: Presence or
- •suspicion or history of breast cancer, endometrial cancer, ovarian cancer,
- •presence or history of venous thromboembolism, arterial thrombosis (e.g.
- •myocardial infarction, angina pectoris) inherited or acquired thrombophilia,
- •presence of liver disease, untreated endometrial hyperplasia, abnormal vaginal
- •bleeding, porphyria, uncontrolled or severe hypertension)
- •First-grade family member with inherited thrombophilia or history of VTE
- •under the age of 60 years
- •Hysterectomy
- •Premature menopause (menopause age <40 years)
- •Known hypersensitivity to the excipients in the estradiol patch: acrylate
- •copolymer, polyethylene terephthalate, a-tocopherol, soy allergy or peanut
- •allergy (component of progesterone capsule)
- •Hormonal contraception or hormone replacement therapy use (estradiol with or
- •without progesterone) in the past 12 months
- •Presence or history of any clinically relevant metabolic, endocrinological,
- •hepatic, renal, cardiovascular, gastrointestinal, or respiratory conditions,
- •history of bone disease or bone marrow disease, known vitamin D deficiency
- •(25-OH vitamin D <30 nmol/L)
- •Recent fracture (<12 months)
- •BMI <20 or BMI >=30
- •Use of drugs including herbal medicine known to affect bone metabolism (e.g.
- •corticosteroids) or to interfere with cytochrome P450 enzyme (CYP) pathways.
- •Exceptions are occasional use of paracetamol, ibuprofen, acetylsalicylic acid
- •or topical medication
- •For adipose tissue biopsy: anticoagulant treatment, allergy to lidocaine
研究者
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