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2015年12月9日
相关药物Maxim
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- niversitätsklinikum Erlangen
- 入组人数
- 30
- 状态
- 进行中（未招募）
- 最后更新
- 7年前
概览
简要总结
暂无简介。
研究者
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
结局指标
主要结局
未指定
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