EUCTR2015-004184-36-DE进行中（未招募）1 期
Prospective, randomised, double-blind, placebo-controlled, single centre phase IIa clinical trial to investigate the safety and tolerability as well as the impact of a substitution of sexual hormones with an estrogen-progestin combination over 10 weeks in addition to in-house psychotherapy on neuro-endocrinological parameters, psychopathology and neuro-psychological performance compared to in-house psychotherapy alone in adult females with anorexia nervosa - HOSA
niversitätsklinikum Erlangen0 个研究点目标入组 30 人开始时间: 2015年12月9日最近更新:
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
- •Female subject
- •18 to 45 years of age
- •Anorexia nervosa
- •Written informed consent
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known hypersentivity to active substances and other ingredients of the IMP
- •Known contra-indication to hormonal contraception
- •Acute major depression
- •Known acute alcohol or drug abuse
- •Severe psychological/psychiatric disorder in addition to anorexia nervosa
- •Acute suicidality
- •Known diabetes mellitus
- •Known severe concomitant disease
- •Use of hormonal depot preparation
- •Pregnancy or breast-feeding
研究者
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