Resting Energy Expenditure in Postmenopausal Women

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Mar 31, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how hormone replacement therapy (HRT), which includes the hormones estradiol and progesterone, affects resting energy expenditure (REE) in postmenopausal women. REE is the amount of energy your body uses while at rest and is important for understanding weight management. Many postmenopausal women are concerned about weight gain during this stage of life, and this study aims to provide clearer evidence on whether HRT helps with energy metabolism, which could influence weight gain or loss.

To participate in this study, women must be healthy, postmenopausal, and have a specific reason for considering hormone therapy, such as symptoms of menopause or osteoporosis. They should also have a body mass index (BMI) between 18.5 and 29.9 and be non-smokers. Participants will be asked to maintain their usual diet and exercise routine for the duration of the study. Throughout the trial, researchers will assess various aspects of health and well-being, including energy levels, body composition, and hormone levels, to better understand the effects of HRT on overall health and weight management.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.)