PostmenopauseMenoBOLISMNCT06905886
Resting Energy Expenditure in Postmenopausal Women
An observational study of Postmenopause and Energy Expenditure, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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 accompanied by weight gain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postmenopause, Energy Expenditure, Hormone Replacement Therapy
- How many people
- 37 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2025to Feb 2027
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal women with an indication for MHT (e.g. climacteric syndrome, osteoporosis, etc.). Women will be recruited at the University Hospital of Bern, Switzerland - Department of Gynecological Endocrinology and Reproductive Medicine.
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University Hospital of Bern, Switzerland; Department of Gynecological Endocrinology and Reproductive Medicine
Bern, 3010
Susanna Weidlinger, Dr. med., +41 31 632 1010, susanna.weidlinger@insel.ch
About this study
Official title: Impact of Menopausal Hormone Therapy on Resting Energy Expenditure in Postmenopausal Women
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 accompanied by weight gain. Fear of this weight gain is a major reason why many women hesitate to initiate or continue menopausal hormone therapy (MHT), with discontinuation often occurring within the first few months. However, scientific evidence on whether MHT influences weight gain remains inconclusive. A Cochrane Review found no significant effect of estrogen or combined estrogen-progestogen therapy on menopause-related weight gain, suggesting that aging and lifestyle changes play a more prominent role.
While the effects of estrogen on energy intake have been well-documented, data on its impact on energy expenditure-particularly resting energy expenditure (REE), the largest component of total energy expenditure-are scarce. Several studies suggest that sex hormones may influence REE, as observed in premenopausal women, where REE increases during the luteal phase when estradiol and progesterone levels are high. However, findings on this topic remain inconsistent, and it is unclear whether estrogen or progesterone plays the primary role. Research on the effects of exogenous hormone administration, such as MHT, on REE is extremely limited, with existing studies producing mixed results. Additionally, the potential influence of progestogens on REE has been largely overlooked. Given that a low REE is a strong predictor of weight gain and obesity, understanding the effects of MHT on REE is crucial.
Read more
This observational clinical trial aims to investigate the precise effect of MHT (estradiol + progesterone) on REE in postmenopausal women with an indication for MHT. Secondary objectives include examining MHT's impact on energy intake, physical activity energy expenditure, performance capacity, body composition, core body temperature, serum hormone profiles (luteinizing hormone, follicle-stimulating hormone, estradiol, progesterone), glucose metabolism, fasting blood lipid levels, and miRNA expression (miR-370 and miR-29b, which are involved in lipid and glucose metabolism). Additionally, the study will assess various aspects of subjective well-being and quality of life.
By addressing the current gaps in scientific knowledge, this study seeks to provide robust evidence on the role of MHT in energy metabolism, potentially reshaping perspectives on its risks and benefits in postmenopausal women.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Menopausal Hormone Therapy (MHT) | Postmenopausal women, receiving Menopausal Hormone Therapy for 4 weeks, following an observation phase of 2 weeks without intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Energy Expenditure (REE)
Difference in absolute REE (kcal/day) before hormonal substitution and after four weeks of MHT
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 37 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanna Weidlinger, Dr. med., Principal investigator, Department of Gynecologic Endocrinology and Reproductive Medicine, University Clinic for Gynecology, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905886
- Sponsor's protocol ID
- 2022-01570
- Acronym
- MenoBOLISM
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because IPD contain health-related data.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Menopausal Hormone Therapy on Resting Energy Expenditure in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06905886
- Acronym / sponsor ID
- MenoBOLISM / 2022-01570
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 accompanied by weight gain. Fear of this weight gain is a major reason why many women hesitate to initiate or continue menopausal hormone therapy (MHT), with discontinuation often occurring within the first few months. However, scientific evidence on whether MHT influences weight gain remains inconclusive. A Cochrane Review found no significant effect of estrogen or combined estrogen-progestogen therapy on menopause-related weight gain, suggesting that aging and lifestyle changes play a more prominent role.
While the effects of estrogen on energy intake have been well-documented, data on its impact on energy expenditure-particularly resting energy expenditure (REE), the largest component of total energy expenditure-are scarce. Several studies suggest that sex hormones may influence REE, as observed in premenopausal women, where REE increases during the luteal phase when estradiol and progesterone levels are high. However, findings on this topic remain inconsistent, and it is unclear whether estrogen or progesterone plays the primary role. Research on the effects of exogenous hormone administration, such as MHT, on REE is extremely limited, with existing studies producing mixed results. Additionally, the potential influence of progestogens on REE has been largely overlooked. Given that a low REE is a strong predictor of weight gain and obesity, understanding the effects of MHT on REE is crucial.
This observational clinical trial aims to investigate the precise effect of MHT (estradiol + progesterone) on REE in postmenopausal women with an indication for MHT. Secondary objectives include examining MHT's impact on energy intake, physical activity energy expenditure, performance capacity, body composition, core body temperature, serum hormone profiles (luteinizing hormone, follicle-stimulating hormone, estradiol, progesterone), glucose metabolism, fasting blood lipid levels, and miRNA expression (miR-370 and miR-29b, which are involved in lipid and glucose metabolism). Additionally, the study will assess various aspects of subjective well-being and quality of life.
By addressing the current gaps in scientific knowledge, this study seeks to provide robust evidence on the role of MHT in energy metabolism, potentially reshaping perspectives on its risks and benefits in postmenopausal women.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Menopausal Hormone Therapy (MHT) | – | –Postmenopausal women, receiving Menopausal Hormone Therapy for 4 weeks, following an observation phase of 2 weeks without intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women with an indication for MHT (e.g. climacteric syndrome, osteoporosis, etc.). Women will be recruited at the University Hospital of Bern, Switzerland - Department of Gynecological Endocrinology and Reproductive Medicine.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resting Energy Expenditure (REE)
Time frame: 4 weeks
Difference in absolute REE (kcal/day) before hormonal substitution and after four weeks of MHT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No. Because IPD contain health-related data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susanna Weidlinger, Dr. med. principal investigator
Department of Gynecologic Endocrinology and Reproductive Medicine, University Clinic for Gynecology, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopause and Energy Expenditure, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanna Weidlinger, Dr. med. (+41 31 632 1010, susanna.weidlinger@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Energy Expenditure (REE) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.