PostmenopauseOPERATENCT05831709
The Influence of Hormone Replacement Therapy and Supervised Exercise Training on Body Composition, Cardiovascular Risk and Insulin Sensitivity in Postmenopausal Women
A study testing Exercise program and Hormonal substitution therapy per SOC in people with Postmenopause and Menopausal Complaints, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This trial investigates whether supervised training in combination with hormonal substitution therapy has an impact on body composition, cardiovascular risk, risk for dementia, osteoporosis and insulin sensitivity in postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Postmenopause, Menopausal Complaints
- What is being tested?
- Exercise program and Hormonal substitution therapy per SOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteBelgium
- Study dates
- 12 May 2023to Dec 2028
- Phase
- Interventional
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women (diagnosed by physician) with complaints due to menopause
- Indication for hormonal substitution therapy (except for the control group)
- Good general health
- BMI: 20-30 kg/m2
- Only the use of cholesterol-, blood pressure- or/and thyroid-regulating medication is permitted
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital - Women's Clinic
Ghent, 9000
+3293320758, gynobs.studies@uzgent.be
About this study
Official title: De Invloed Van Hormoonsubstitutietherapie en Gesuperviseerde Training op Lichaamssamenstelling, Cardiovasculair Risico en Insulinegevoeligheid Bij Postmenopauzale Vrouwen
This trial investigates whether supervised training in combination with hormonal substitution therapy has an impact on body composition, cardiovascular risk, risk for dementia, osteoporosis and insulin sensitivity in postmenopausal women.
Read the detailed description
270 postmenopausal women will be included. Each woman will perform a 12 to 24 weeks sports program with supervised training exercises.
- Conditions
- Postmenopause, Menopausal Complaints
- Being tested
- Exercise program, Hormonal substitution therapy per SOC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
The intervention consists of a supervised exercise program
Hormonal substitution therapy per SOCDrug
Subjects take hormonal substitution therapy per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Supervised training + immediate hormone substitution therapy per SOC | Experimental | Not described Receives: Other: Exercise program; Drug: Hormonal substitution therapy per SOC |
| Supervised training + delayed hormone substitution therapy per SOC | Experimental | Not described Receives: Other: Exercise program |
| Delayed supervised training + immediate hormone substitution therapy per SOC | Active comparator | Not described Receives: Drug: Hormonal substitution therapy per SOC |
| Supervised training | Experimental | Subjects who will start hormone substitution therapy in standard of care can participate in the trial and have 50% chance to be randomised in the exercise group. Receives: Other: Exercise program |
| No supervised training | No intervention | Subjects who will start hormone substitution therapy in standard of care can participate in the trial and have 50% chance to be randomised in the non-exercise group. |
| Control group | No intervention | Subjects with menopausal complaints who do not want hormone substitution therapy or supervised training, can also participate in the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the cardiovascular risk
The cardiovascular risk will be estimated by blood- and urine analysis, blood pressure and a AGE (i.e. Advanced Glycation End products)-reader. There are three timepoints of measurement; once at inclusion, once at 12 weeks, and once at 24 weeks.
Measured: +12 weeks; +24 weeks
Evaluation of the insulin sensitivity
The insulin sensitivity will be estimated by blood- and urine analysis and a AGE (i.e. Advanced Glycation End products)-reader. There are three timepoints of measurement; once at inclusion, once at 12 weeks, and once at 24 weeks.
Measured: +12 weeks, +24 weeks
Secondary outcomes (2)
Evaluation of the body composition
The body composition will be measured using bioimpedance technology (Tanita-scale). The body composition will be measured three times; once at inclusion, once at 12 weeks and once at 24 weeks.
Measured: +12 weeks; +24 weeks
Evaluation of the muscle mass
The musle mass will be evaluated by performing a maximal effort test (i.e. cycling test). This test will be performed three times; once at inclusion, once at 12 weeks, and once at 24 weeks.
Measured: +12 weeks; +24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start12 May 2023
- Primary completion31 Dec 2027 (estimated)
- Study completionDec 2028 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831709
- Sponsor's protocol ID
- ONZ-2023-0015
- Acronym
- OPERATE
- Status last verified
- Nov 2025
- First submitted
- 12 Apr 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De Invloed Van Hormoonsubstitutietherapie en Gesuperviseerde Training op Lichaamssamenstelling, Cardiovasculair Risico en Insulinegevoeligheid Bij Postmenopauzale Vrouwen
- ClinicalTrials.gov ID
- NCT05831709
- Acronym / sponsor ID
- OPERATE / ONZ-2023-0015
- Conditions
- Postmenopause, Menopausal Complaints
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Apr 2023 (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.
This trial investigates whether supervised training in combination with hormonal substitution therapy has an impact on body composition, cardiovascular risk, risk for dementia, osteoporosis and insulin sensitivity in postmenopausal women.
Detailed description
270 postmenopausal women will be included. Each woman will perform a 12 to 24 weeks sports program with supervised training exercises.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Supervised training + immediate hormone substitution therapy per SOC | Experimental | Other: Exercise program, Drug: Hormonal substitution therapy per SOC |
| Supervised training + delayed hormone substitution therapy per SOC | Experimental | Other: Exercise program |
| Delayed supervised training + immediate hormone substitution therapy per SOC | Active comparator | Drug: Hormonal substitution therapy per SOC |
| Supervised training | Experimental | Other: Exercise programSubjects who will start hormone substitution therapy in standard of care can participate in the trial and have 50% chance to be randomised in the exercise group. |
| No supervised training | No intervention | –Subjects who will start hormone substitution therapy in standard of care can participate in the trial and have 50% chance to be randomised in the non-exercise group. |
| Control group | No intervention | –Subjects with menopausal complaints who do not want hormone substitution therapy or supervised training, can also participate in the trial. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal women (diagnosed by physician) with complaints due to menopause
- Indication for hormonal substitution therapy (except for the control group)
- Good general health
- BMI: 20-30 kg/m2
- Only the use of cholesterol-, blood pressure- or/and thyroid-regulating medication is permitted
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise programThe intervention consists of a supervised exercise program | Other | Supervised training, Supervised training + delayed hormone substitution therapy per SOC, Supervised training + immediate hormone substitution therapy per SOC |
| Hormonal substitution therapy per SOCSubjects take hormonal substitution therapy per standard of care | Drug | Delayed supervised training + immediate hormone substitution therapy per SOC, Supervised training + immediate hormone substitution therapy per SOC |
Primary outcome
Evaluation of the cardiovascular risk
Time frame: +12 weeks; +24 weeks
The cardiovascular risk will be estimated by blood- and urine analysis, blood pressure and a AGE (i.e. Advanced Glycation End products)-reader. There are three timepoints of measurement; once at inclusion, once at 12 weeks, and once at 24 weeks.
Evaluation of the insulin sensitivity
Time frame: +12 weeks, +24 weeks
The insulin sensitivity will be estimated by blood- and urine analysis and a AGE (i.e. Advanced Glycation End products)-reader. There are three timepoints of measurement; once at inclusion, once at 12 weeks, and once at 24 weeks.
2 secondary outcomes
Evaluation of the body composition
Time frame: +12 weeks; +24 weeks
Evaluation of the muscle mass
Time frame: +12 weeks; +24 weeks
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 18 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program and Hormonal substitution therapy per SOC in people with Postmenopause and Menopausal Complaints, run by University Hospital, Ghent at 1 site in Belgium.
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 5 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 18 Nov 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 Belgium. 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 Herman Depypere (003293323783, studieco.vrouwenkliniek@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the cardiovascular risk (time frame: +12 weeks; +24 weeks). The study lists 2 primary outcomes in all. 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 18 Nov 2025; AzTrials last refreshed its copy on 27 Oct 2026.