Estradiol for the treatment of anorexia nervosa

Phase 2

Recruiting

• Conditions: anorexia nervosa; Mental Health - Eating disorders

• Registration Number: ACTRN12623000897662
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-21
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1.Diagnosis of AN (restrictive or binge-eating/purging subtype), in accordance with the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5).
2.16 years or older in age.
3.Baseline body mass index (BMI) above 14
4.No initiation of therapies targeting AN within the 4 weeks prior to screening. This includes pharmacological and psychological therapies.
5.No increase or initiation of medications with appetite suppressing and/or weight loss effects within the 4 weeks prior to screening.
6.Demonstrated capacity to give informed consent
7.Participants who are engaged with an existing clinical treatment team for their AN at the time of enrolment and over the course of trial participation. For this purpose, engagement is defined as maintaining clinical contact, on average, at least every 4 weeks.
8.Consent for the research team to communicate with the participant’s clinical treatment team regarding a) their progress through the trial and b) communicate clinical deterioration and risks to allow facilitation of appropriate management, where clinically indicated.

Exclusion Criteria

1.Inability to provide informed consent.
2.Hospitalisation within the 2 months prior to screening for the purpose of weight restoration or treatment of other medical instability that has a causal link to AN.
3.Physical parameters meeting Criteria for Medical Ward Admission as per the Alfred Health Eating Disorder – Inpatient Access and Treatment Pathways Guideline, namely:
a.High refeeding risk;
b.Vital signs as follows:
i.Systolic BP < 80 mmHg;
ii.Postural BP drop > 20 mmHg systolic, > 10 mmHg diastolic
iii.Heart rate < 40 or > 110;
iv.Temperature < 35.5oC
c.Blood tests within the preceding 7 days showing:
i.Blood glucose <3.0 mmol/L
ii.Serum sodium <130 mmol/L
iii.Serum magnesium <0.6 mmol/L
iv.Serum potassium <3.0 mmol/L
v.Serum phosphate <0.7 mmol/L
vi.Glomerular filtration rate < 60 ml/min (Cockroft-Gault)
vii.Albumin <27 g/L
viii.Liver enzymes ALT > 3 x upper limit of normal
ix.Neutrophils <1.0x109/L
d.GCS <15
4.Known history of breast, endometrial or ovarian cancer (individual, mother, or maternal grandmother)
5.Women aged 40 or over who have not had a normal mammogram in the last 24 months
6.Abnormal pap smear in the last 24 months
7.History of blood clots (e.g., deep vein thrombosis, pulmonary embolism)
8.Previous arterial thromboembolic disease (e.g., stroke)
9.Diagnosed with Type I diabetes, hyperthyroidism, Crohn’s disease or other conditions that reduce weight
10.Taking greater than or equal to 3 psychotropics
11.Other clinically significant cardiac, respiratory, renal, or endocrine conditions, or evidence of medical instability, at the discretion of the investigator
12.Concomitant neurological disorder or a history of a seizure disorder
13.Any contraindication to estrogen
14.Participants who are pregnant or lactating
15.Current substance use meeting DSM-5 criteria for severe substance use disorder
16.Per DSM-5, had ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, or delusional disorder as assessed by the SCID-5 at the time of screening.
17.Use of any investigational procedure (e.g., clinical trial) within 30 days prior to randomisation. In case of exposure to an investigational medicinal product, investigator must ensure that it is adequately washed out prior to randomisation (at least 30 days or 5 half-lives of the investigational medicinal product, whatever is longer).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Change in Eating Disorder Symptoms scale (CHEDS)<br>CHEDS assesses change in eating disorder symptoms during treatment. [ Baseline vs. 12 weeks post-commencement of treatment (Visit 5)]

Secondary Outcome Measures

Name	Time	Method
Change in Body Mass Index (height determined by stadiometer, and weight determined using balance scales)[ Baseline vs 12 weeks post-commencement of treatment (Visit 5)]