Hormone therapy's effect on liver disease in postmenopausal women
COmmencing Menopausal HOrmone Replacement Therapy and the Effect on Metabolic-dysfunction Associated Steatotic Liver Disease: a Pilot Mechanistic Study
This study is testing if hormone replacement therapy can help postmenopausal women with liver disease by looking at how it affects liver fat and overall health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford, Oxfordshire) |
| Trial ID | NCT06704516 on ClinicalTrials.gov |
What this trial studies
This pilot mechanistic study investigates the impact of menopausal hormone replacement therapy (HRT) on metabolic dysfunction-associated steatotic liver disease (MASLD) in postmenopausal women. The study aims to understand how HRT, which contains estrogen, may influence liver fat accumulation and related metabolic changes that are exacerbated after menopause. By enrolling women who are postmenopausal and have low estrogen levels, the trial will assess the potential benefits of HRT in managing MASLD, a condition that is increasingly prevalent due to rising obesity and diabetes rates. Participants will be monitored for compliance and health outcomes related to liver function and metabolic health.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women aged 18 and above with low estrogen levels and a body mass index between 18 and 45 kg/m2.
Not a fit: Patients with known chronic liver disease other than MASLD will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective treatments for managing liver disease in postmenopausal women.
How similar studies have performed: While there is ongoing research into the effects of hormone therapy on metabolic conditions, this specific approach to MASLD in postmenopausal women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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) * Low oestradiol levels * No exposure to systemic oestrogen-based HRT within the previous 3 months * Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial. 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. * Potential participants who have participated in another research trial involving an investigational product in the past 12 weeks. * Potential participants without a sufficient understanding of written or verbal English to participate in the study.
Where this trial is running
Oxford, Oxfordshire
- Oxford Centre for Diabetes Endocrinology and Metabolism (OCDEM), Churchill Hospital — Oxford, Oxfordshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Jiawen Dong, MB BChir, MRCP
- Email: jiawen.dong@ocdem.ox.ac.uk
- Phone: +441865 857300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.