Menopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal … (NCT06715514) | Clinical Trial Compass
RecruitingNot Applicable
Menopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal Women With Diabetes
Switzerland96 participantsStarted 2025-02-18
Plain-language summary
The overall aim is to investigate the hypothesis that restoring E2 levels through MHT improves glucose and energy homeostasis and potentiates the beneficial effects of GLP-1RA in early postmenopausal women with pre- or existing type 2 diabetes.
The primary objective is to assess the efficacy of combined MHT and GLP-1RA in improving glucose control in early postmenopausal women with pre- or existing type 2 diabetes, compared to GLP-1RA alone. Secondary objectives include efficacy analyses on body weight, other measures of cardiometabolic health, lifestyle behaviour, menopausal symptoms, and the exploration of mechanisms underpinning potential glycaemic and weight control benefits, and biomarkers of haemostasis.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Individuals fulfilling at enrolment all of the following inclusion criteria are eligible for the study:
* Early postmenopausal status (STRAW+10 stage +1b or +1c and FSH\>25.0mU/L)
* Presence of menopausal symptoms (total MRS-II score ≥1)
* BMI ≥ 27.0kg/m2
* Pre- or existing type 2 diabetes (HbA1c 5.7%-8.5%)
* No prior or current use of MHT
The presence of any of the following exclusion criteria will lead to exclusion of the individuals:
* DPP4-inhibitor, SLGT2-inhibitor or sulfonylurea use within 8 weeks prior to study enrolment
* GLP-1RA use within 6 months prior to study enrolment
* Insulin therapy within 8 weeks prior to study enrolment
* History of bariatric surgery
* More than 2% change in body weight within three months prior to study enrolment (based on documented or reported weights)
* Contraindications for the use of the study medication as per prescription labelling: Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2
* Known or suspected cancer of breast or other sexual organ, abnormal genital bleeding of unknown cause, hepatic neoplasia
* Arterial or venous thromboembolic events, porphyria
* Known allergy or hypersensitivity to Wegovy®, Estradot® or Utrogestan® (pharmaceutical agents or any of the excipients)
* Systemic hormone therapy or hormonal contraceptives (e.g. estrogens, progestogens, androgens) during the study and within 12 months prior to participation
* Herbal remedies and complimentary medicines…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is looking at how menopausal hormone therapy and GLP-1 medications together affect blood sugar control in postmenopausal women with type 2 diabetes — is my current diabetes management stable enough that participating in a study involving both of these treatments at once would be safe for me?
2Since the main thing being measured is change in HbA1C, could being in this trial mean my diabetes medications or hormone therapy get adjusted in ways that might affect my blood sugar control during the study, and what would happen to my care if my HbA1C got worse?
3This trial is listed as Phase NA, which often means it's an early-stage or exploratory study — does that mean there's less established safety data on combining hormone therapy and GLP-1 agonists specifically for women in my situation, and what risks should I be aware of?
4I may already be on a GLP-1 medication or considering menopausal hormone therapy on my own — would joining this trial affect my ability to make changes to those treatments based on what my doctor recommends for me personally?
5Are there standard treatment options for managing both menopause symptoms and type 2 diabetes that I should consider trying first before exploring an experimental combination like the one being studied in this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.