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

COmmencing Menopausal HOrmone Replacement Therapy and the Effect on Metabolic-dysfunction Associated Steatotic Liver Disease: a Pilot Mechanistic Study (NCT06704516) is a Phase 1 interventional studying Menopause and Metabolic Dysfunction Associated Steatotic Liver Disease, sponsored by University of Oxford. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Menopause, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 10 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Potential participant is willing and able to give willing to sign a consent form 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. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Menopausal hormone therapy

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)

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Oxford Centre for Diabetes Endocrinology and Metabolism (OCDEM), Churchill Hospital

Oxford, Oxfordshire, United Kingdom

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06704516), the sponsor (University of Oxford), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06704516 clinical trial studying?

Who can participate in NCT06704516?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06704516?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06704516. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06704516. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.