NCT06704516 COmmencing Menopausal HOrmone Replacement Therapy and the Effect on Metabolic-dysfunction Associated Steatotic Liver Disease: a Pilot Mechanistic Study
| NCT ID | NCT06704516 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Oxford |
| Condition | Menopause |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-01 |
| Primary Completion | 2025-08-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-01 with a primary completion date of 2025-08-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. A lack of oestrogen is also believed to lead to harmful changes in adipose (body fat), which has an important role in the development of MASLD. Oestrogen contained in hormone replacement therapy (HRT) is an effective treatment for hot flushes and other problems in menopause. The popularity of HRT has increased dramatically in the United Kingdom in recent years, however the exact way in which it affects adipose and MASLD is unclear. The investigators will study how HRT affects the processes that drive MASLD in 10 women before and after using the treatment. This is a small-scale pilot study to understand feasibility of recruitment and test the procedures for a future, larger-scale studies. The investigators will recruit women who are about to begin HRT for the first time and perform the same tests for each participant before starting HRT, and after using HRT for 12-weeks. The participants will undergo meal testing including non-radioactive, stable isotopes, and blood and breath samples will be collected to measure fat processing. The total fat content of the liver will be measured using magnetic resonance imaging (MRI) scans. Adipose samples will be collected, fat metabolites will be measured and the distribution of fat around the body will be assessed using a dual energy x-ray absorptiometry (DEXA) scan. To find out how HRT affects these processes, the results from before and after using HRT will be compared. Understanding how HRT affects adipose and the liver may help reduce the development of MASLD in women after the menopause and improve their health and survival.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06704516 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06704516 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06704516 currently recruiting?
Yes, NCT06704516 is actively recruiting participants. Contact the research team at jiawen.dong@ocdem.ox.ac.uk for enrollment information.
Where is the NCT06704516 trial being conducted?
This trial is being conducted at Oxford, United Kingdom.
Who is sponsoring the NCT06704516 clinical trial?
NCT06704516 is sponsored by University of Oxford. The trial plans to enroll 10 participants.