E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Anorexia nervosa |
Anorexia nervosa |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
This pilot study will test the feasibility and effect of estrogen replacment theraphy as treatment for anorexia nervosa. |
Not applicable |
|
E.2.2 | Secondary objectives of the trial |
Not applicable |
Not applicable |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The inclusion criteria are voluntary participation secured by written informed consent by the patient herself, in addition to consent from parents/next of kin, age between 13 to 18 years on inclusion, BMI < 17.5, and at least had one menstruation, diagnosed with anorexia nervosa (F50.0, ICD-10, and restrictive anorexia in DSM-V) by a clinical specialist (specialist in clinical psychology or specialist in psychiatry). Patients with concomitant anxiety and depression will be included. |
Not applicable |
|
E.4 | Principal exclusion criteria |
One or more contra indices for use of hormonal contraceptives, hereditary predisposition for venous or arterial thrombosis, any unexplained vaginal bleeding, diagnosed or susceptible diabetes mellitus, any cerebrovascular disease, any type of heart failure, any neurological disease or structural brain damage, any past or present episodes of psychosis or mania, any current use of antipsychotic medication, diagnoses of mental retardation (F70-F79), pregnancy, past or present substance abuse. |
Not applicable |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The present trial have two primary outcome variables, anxiety levels measured by STAI-C and specific symptoms of anorexia measured by the EDE-Q. The State Trait Anxiety Inventory – Children (STAI-C) (33) will be used to measure levels of state dependent and traits of anxiety. The Eating Disorder Exam Questionnaire version 6.0 (EDEQ-6.0) (34, 35) will be used to assess symptom levels of anorexia because these inventories are the considered as reliable, valid and highly utilized in clinical studies |
Not applicable |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
13 weeks duration of tretament |
Not applicable |
|
E.5.2 | Secondary end point(s) |
Secondary outcome measures are plasma levels of ghrelin, T3, T4, and cortisol measured in saliva. Furthermore, weight, and cognitive performance are secondary outcome measures. |
Not applicable |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
13 weeks of tretament. |
Not applicable |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |