ACTRN12617001317381招募中2 期
A Randomised Placebo Controlled Trial of Estradiol for the Treatment of Women with Borderline Personality Disorder
Alfred Hospital0 个研究点目标入组 72 人开始时间: 2017年9月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 43 Years（—）
- 性别
- Female
入选标准
- •– Age 18-43 years
- •– Primary diagnosis of BPD, assessed by the Diagnostic Interview for Borderline Patients (DIB-R)
- •– Be willing to use appropriate barrier contraceptive precaution for the duration of the study
排除标准
- •Known history of breast, endometrial or ovarian cancer
- •Women aged 40 or over who have not had a normal mammogram in the last 24 months
- •Abnormal pap smear in the last 24 months
- •Contraindications to estradiol
- •Current pregnancy or trying to become pregnant,
- •History of blood clots (e.g. deep vein thrombosis, pulmonary embolism)
- •Previous arterial thromboembolic disease (e.g. stroke)
- •Acute, high risk of suicide such that inpatient admission is required, as determined by PI Kulkarni (psychiatrist) based on her expert clinical assessment.
- •Taking more than 5 psychotropic medications
- •Taking OCP that do not have 20, 30 or 35mcg estradiol component
- •New/ planned changes to psychotropic medication/psychotherapy plans
- •Consistent, severe substance abuse in last 3 months
- •Smoking more than 20 cigarettes per day
研究者
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