Status:
NOT_YET_RECRUITING
Resting Energy Expenditure in Postmenopausal Women
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Postmenopause
Energy Expenditure
Eligibility:
FEMALE
18+ years
Brief Summary
Obesity and its associated comorbidities are rising at an alarming rate, particularly among postmenopausal women. Menopause, characterized by a decline in estradiol and progesterone levels, is often a...
Eligibility Criteria
Inclusion
- Informed Consent as documented by signature
- Healthy postmenopausal woman
- Indication for MHT (e.g. climacteric syndrome, osteoporosis, etc.)
- Body Mass Index (BMI) 18.5 - 29.9 kg/m2
- Non smoker
- Willingness to maintain unchanged dietary habits and the type and frequency of sports activities throughout the entire 6-week study period. I.e. no dietary changes/restrictions, start of a special exercise program or start of any weight-loss measures are planned during the study period.
Exclusion
- Pregnancy or Lactation
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- Systemic hormone therapy or hormonal contraception (estrogens, progestogens, androgens) during the study and within 12 weeks prior to study entry
- Phytotherapeutics for therapy of climacteric syndrome during the study and within 12 weeks prior to study entry
- Use of psychotropic drugs and other drugs that have an influence on resting energy expenditure during the study and within 12 weeks prior to study entry
- Substance abuse (e.g. nicotine, alcohol, drugs)
- Use of appetite suppressants
- Hypersensitivity or allergy to class of drugs or to any ingredients of the used IMPs (Oestrogel® and Utrogestan®)
- Contraindication for estradiol or progesterone medication according to swissmedicinfo.ch: Neoplasia of the breast or other sexual organ; Benign or malignant liver tumors; Acute or chronic liver disease; Cholestatic jaundice; Porphyria; Arterial or venous thromboembolic events; Abnormal genital bleeding of unknown cause
- Use of medication with active ingredients that interact with the metabolization of estradiol or progesterone. For each medication a drug interaction check will be performed: Lexicomp® Drug Interactions, UpToDate®
- Known or suspected non-compliance due to inability to follow the procedures of the study (e.g. illiteracy, language problems, psychological disorders, dementia, etc.)
Key Trial Info
Start Date :
August 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT06905886
Start Date
August 1 2025
End Date
February 1 2027
Last Update
April 2 2025
Active Locations (1)
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1
University Hospital of Bern, Switzerland; Department of Gynecological Endocrinology and Reproductive Medicine
Bern, Switzerland, 3010