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New treatment option for Menopause
Official title COmmencing Menopausal HOrmone Replacement Therapy and the Effect on Metabolic-dysfunction Associated Steatotic Liver Disease: a Pilot Mechanistic Study
ClinicalTrials.gov ID: NCT06704516
What this study is testing
What is Menopausal hormone therapy?
Menopausal hormone therapy is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for menopause.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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:
You likely can't join if
- 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...
- 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.
See the full eligibility 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 \ 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Oxford, Oxfordshire, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oxford, Oxfordshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.