Comparison of treatment with sexual hormones and psychotherapy over 10 weeks vs. psychotherapy only in adult females with anorexia nervosa
Phase 1
- Conditions
- Substitution of sexual hormones in adult females with anorexia nervosaMedDRA version: 18.1 Level: LLT Classification code 10063915 Term: Substitution therapy System Organ Class: 100000004865Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]
- Registration Number
- EUCTR2015-004184-36-DE
- Lead Sponsor
- niversitätsklinikum Erlangen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
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
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method