Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06715514

Menopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal Women With Diabetes

Led by Lia Bally · Updated on 2025-03-06

96

Participants Needed

1

Research Sites

79 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Menopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal Women With Diabetes

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Early postmenopausal status (STRAW+10 stage +1b or +1c and FSH > 25.0 mU/L)
  • Presence of menopausal symptoms (total MRS-II score 651)
  • Body mass index (BMI) 65 27.0 kg/m2
  • Pre- or existing type 2 diabetes with HbA1c between 5.7% and 8.5%
  • No prior or current use of menopausal hormone therapy
Not Eligible

You will not qualify if you...

  • Use of DPP4-inhibitor, SLGT2-inhibitor, or sulfonylurea within 8 weeks before enrollment
  • Use of GLP-1 receptor agonists within 6 months before enrollment
  • Insulin therapy within 8 weeks before enrollment
  • History of bariatric surgery
  • More than 2% change in body weight within 3 months before enrollment
  • Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2
  • Known or suspected breast or other sexual organ cancer, unknown cause of abnormal genital bleeding, or liver tumors
  • Arterial or venous thromboembolic events or porphyria
  • Known allergy or sensitivity to Wegovy4, Estradot4, or Utrogestan4
  • Use of systemic hormone therapy or hormonal contraceptives during the study or within 12 months prior
  • Use of herbal or complementary medicines for menopausal symptoms during the study
  • Physical or psychological conditions or medical interventions likely to interfere with the study
  • Participation in another clinical trial that affects study results
  • Inability to read German
  • Unwillingness to follow study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital Bern

Bern, Switzerland, 3010

Actively Recruiting

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Research Team

P

Prof. Dr. med. et Dr. phil.Lia Bally

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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