Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
390
Sex
Women only
Ages
Ages 45 Years to 65 Years
Primary completion
2027-12-31
Last update
2025-11-18

What this trial studies

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.

Conditions in scope

  • Postmenopause
  • Menopausal Complaints

Interventions

  • Exercise program (Other) — The intervention consists of a supervised exercise program
  • Hormonal substitution therapy per SOC (Drug) — Subjects take hormonal substitution therapy per standard of care

Who can join

Women only · Ages 45 Years to 65 Years

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

Exclusion criteria

  • See ClinicalTrials.gov for full exclusion criteria.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

CityState / RegionFacilitySite status
Ghent Ghent University Hospital - Women's Clinic Recruiting

Status & timeline

  • Overall status: Recruiting
  • Study type: Interventional
  • Phase: N/A
  • Start date: 2023-05-12
  • Primary completion: 2027-12-31
  • Last update posted: 2025-11-18
  • First posted: 2023-04-26

Lead sponsor: University Hospital, Ghent (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

  • Evaluation of the cardiovascular risk (+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 (+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.

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.

Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT05831709 before contacting a site.

ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.