Investigating the Efficacy of Estradiol in Anorexia Nervosa Treatment
About this study
Research Team
Professor Jayashri Kulkarni, Dr Eveline Mu, Dr Romi Goldschlager, Dr Qi Li, Dr Eva Gregertsen, Karen Goldschlager
Institution
Monash University
Ethics Approval Number
HREC 480/23
Funding Source
Philanthropic
Project Start Date
18 March 2024
Project End Date
1 March 2027
Participants
Female participants with Anorexia Nervosa, aged 16+. Able to travel ~5 times to our Melbourne based clinic over 3 - 4 month period
What is Involved
This study involves a pre-screening call to assess eligibility, an in person screening assessment and then 4 individual visits to the clinic (with a follow-up visit approximately 6 months after trial commencement). Each visit will involve a medical screen and questionnaires related to mental health and AN symptoms. When eligibility is confirmed, participants will be randomly allocated to the estrogen or placebo group. Neither the participant or researchers will know which group the participant is allocated to. They will be provided with patches to wear on their skin for the 3 month trial. Participants will be supported by the trial doctors over this time period to monitor side effects and adverse events.
Ethics Approval Number
HREC 480/23
Location
Level 4, 607 St Kilda Road, Melbourne VIC 3004
Contact Details
Dr Eva Gregertsen - phone: (03) 9076 9802, email: THRED@monash.edu
This clinical trial investigates the effectiveness of a 50mcg/day transdermal estradiol patch in treating anorexia nervosa (AN). Building on preliminary evidence suggesting estradiol's role in mood, cognition, bone health, and appetite regulation, this study aims to explore its therapeutic potential in addressing the multifaceted symptoms of AN. Trial Objective: 1. Assess the impact of the transdermal estradiol patch on improving psychological symptoms of AN from baseline to the end of treatment (12 weeks). 2. Evaluate the effectiveness of the estradiol patch in stabilising and increasing body mass from baseline to the end of treatment. Eligibility Criteria: Current diagnosis of AN (can be assessed at screening if not formally diagnosed) Age 16 or older Female Trial Design & Procedure This clinical trial will enrol 50 participants who will be randomly assigned to receive either the estradiol patch (50mcg/day) or a placebo, for a duration of 12 weeks. Participants’ eating disorder symptoms and broader psychological symptoms will be measured every 4 weeks. Potential Benefits & Positive Outcomes: Demonstrate the effectiveness of estradiol in improving psychological symptoms and body mass in AN Provide insights into estradiol's role in mood and cognition, and its regulatory effects on appetite. Offer a novel, potentially more effective treatment option for AN, addressing the urgent need for innovative therapeutic strategies in this challenging and often chronic condition.
« Back to Browse Resources