EUCTR2017-004729-34-DE进行中（未招募）1 期
Effects of transdermal estrogen on Bone Mass in adolescent female patients with Anorexia nervosa (AN) – a placebo-controlled, double-blind, randomized, interventional study
Medical Center- Universtíty of Freiburg Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics0 个研究点目标入组 30 人开始时间: 2019年1月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
入选标准
- •Subjects who meet all of the following inclusion criteria will be eligible for enrollment in the study:
- •DSM V (307.1) for Anorexia nervosa
- •Amenorrhea for a minimum of 3 months preceding study participation
- •Age 14-20 years
- •Bone age = 14 years
- •BMI-Percentile = 5%
- •The patient, if a female of childbearing potential and sexually active, must use a copper IUD (Intra Uterine Device).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Primary amenorrhea
- •Premature ovarian failure, as demonstrated by an elevated FSH
- •Diseases known to affect bone metabolism including:
- •?untreated thyreoid disease
- •?cushing syndrome
- •?pituitary disease
- •?renal failure
- •?prior bone fracture within 6 months of the study
- •Medication known to affect bone metabolism (including gonadal steroids within the last 3 months)
- •Evidence of:
- •?Suicidality
- •?Substance abuse
- •Abnormal TSH
- •Hematocrit < 30%
- •Potassium < 3,0 mmol/l
- •Glucose < 50 mg/dl
- •Pregnancy/lactation
- •History of malignancy
- •Contraindications to estrogen therapy (for girls with AN)
研究者
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