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New treatment option for Menopause
Official title Menopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal Women With Diabetes
ClinicalTrials.gov ID: NCT06715514
What this study is testing
What is GLP-1 Receptor Agonist?
GLP-1 Receptor Agonist is an investigational medicine, being studied as a potential treatment for menopause.
Also referred to as Semaglutide.
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
- 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.
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
- Individuals fulfilling at enrolment all of the following 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%)
You likely can't join if
- 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)
See the full eligibility criteria
- Individuals fulfilling at enrolment all of the following 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
- 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 for menopausal symptoms during the study
- Physical or psychological condition or any medical intervention (including medication not specified above) likely to interfere with the normal conduct of the study and interpretation of the study results as judged by...
- Participation in another clinical trial that interferes with the interpretation of the study results
- Inability to read German
- Unwillingness to follow the study procedures
The study team makes the final eligibility decision.
Where it's taking place
- Bern, Switzerland
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 Bern, Switzerland. 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.