COmmencing Menopausal HOrmone Replacement Therapy and the Effect on Metabolic-dysfunction Associated Steatotic Liver Disease: a Pilot Mechanistic Study

What this trial studies

Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common cause of chronic liver disease worldwide, currently affecting approximately 1-in-4 people globally. The prevalence is expected to rise further, driven at least partly by the epidemic of obesity and diabetes. MASLD is a condition of fat build-up in the liver that can progress to liver scarring which is associated with higher chances of death. Women are more than twice as likely to develop MASLD after menopause compared to before menopause, and previous research has shown that this may be caused by a lack of oestrogen.

Conditions in scope

• Menopause
• Metabolic Dysfunction Associated Steatotic Liver Disease

Interventions

• Menopausal hormone therapy (Drug) — Any brand, composition, route and dose of systemic menopausal hormone therapy containing oestrogen. Brands of HRT include oestrogel, Evorel, Lenzetto, Estradot, Progynova (this list is not exhaustive)

Who can join

Women only · Ages 18 Years and up

Inclusion criteria

• Potential participant is willing and able to give informed consent for participation in the trial
• In the Investigator's opinion, is able and willing to comply with all trial requirements
• Female, aged 18 years and above
• Body mass index 18 to 45 kg/m2
• Postmenopausal status:
• For women ≥ 40 defined clinically (amenorrhoea for ≥ 1 year) or biochemically (FSH \>30IU/L on 2 occasions 4-6 weeks apart).
• For women \< 40 defined as a combination of oligomenorrhoea/amenorrhoea for ≥ 4 months and FSH \>30IU/L on 2 occasions 4-6 weeks apart
• Women who have undergone bilateral oophorectomy (no additional testing is required)

Exclusion criteria

• Potential participant with known chronic liver disease, with the exception of MASLD
• The use of drugs which, in the opinion of the investigator, will significantly impact on hepatic lipid content or metabolism. This applies to drugs currently being used or used in the past, within a timeframe where the investigator believes it may impact hepatic lipid content or metabolism.
• Potential participant with any other medical explanation for amenorrhoea, apart from menopause
• History of harmful alcohol consumption (\>35 units/week) or alcohol misuse disorder
• Potential participants with contraindication to MRI
• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
• Potential participant with life expectancy of less than 6 months.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: PHASE1
• Start date: 2025-01
• Primary completion: 2025-08-05
• Last update posted: 2025-01-13
• First posted: 2024-11-26

Sponsor & contact

Lead sponsor: University of Oxford (Other)

Collaborators: Oxford University Hospitals NHS Trust

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Recruitment into an experimental medicine study investigating the impact of HRT on MASLD (7 months)
  Number of participants who are screened and recruited into the study

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.