The Influence of Hormone Replacement Therapy and Supervised Exercise Training on Body Composition, Cardiovascular Risk and Insulin Sensitivity in Postmenopausal Women

NCT ID: NCT05831709

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-12

Study Completion Date

2028-12-31

Brief Summary

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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

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270 postmenopausal women will be included. Each woman will perform a 12 to 24 weeks sports program with supervised training exercises.

Conditions

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Postmenopause Menopausal Complaints

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Supervised training + immediate hormone substitution therapy per SOC

Group Type EXPERIMENTAL

Exercise program

Intervention Type OTHER

The intervention consists of a supervised exercise program

Hormonal substitution therapy per SOC

Intervention Type DRUG

Subjects take hormonal substitution therapy per standard of care

Supervised training + delayed hormone substitution therapy per SOC

Group Type EXPERIMENTAL

Exercise program

Intervention Type OTHER

The intervention consists of a supervised exercise program

Delayed supervised training + immediate hormone substitution therapy per SOC

Group Type ACTIVE_COMPARATOR

Hormonal substitution therapy per SOC

Intervention Type DRUG

Subjects take hormonal substitution therapy per standard of care

Supervised training

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.

Group Type EXPERIMENTAL

Exercise program

Intervention Type OTHER

The intervention consists of a supervised exercise program

No supervised training

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Control group

Subjects with menopausal complaints who do not want hormone substitution therapy or supervised training, can also participate in the trial.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise program

The intervention consists of a supervised exercise program

Intervention Type OTHER

Hormonal substitution therapy per SOC

Subjects take hormonal substitution therapy per standard of care

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ghent University Hospital - Women's Clinic

Ghent, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Herman Depypere

Role: CONTACT

003293323783

Study coordinator Women's Clinic

Role: CONTACT

003293323783

Facility Contacts

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Role: primary

+3293320758

Other Identifiers

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ONZ-2023-0015

Identifier Type: -

Identifier Source: org_study_id

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