Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
180
Sex
Women only
Ages
Ages 18 Years to 65 Years
Primary completion
2025-06-14
Last update
2025-01-24

What this trial studies

The three-year interventional study has the following objectives: The study aims to assess the prevalence of sarcopenia in menopausal women receiving hormone replacement therapy or not compared with pre-menopausal women. The study population will be divided into groups according to the intake or not of hormonal therapy of menopause as per normal clinical practice and the menopausal state: GROUP A - menopausal patient taking hormone therapy GROUP B - menopausal patient not taking hormone therapy GROUP C - pre-menopausal patients who do not take hormonal products The primary objective is to compare the strength and muscle mass outcomes of HRT in menopausal women compared with those who do not use it and women in pre-menopausal age. Survey methods such as SARC-F, Handgrip test, Chair stand test and bio impedance

Conditions in scope

  • Sarcopenia

Interventions

  • SARC-F, Handgrip test, Chair stand test (Diagnostic Test) — The SARC-F questionnaire is a simple to use questionnaire consisting of five questions about daily actions.To test the force will be used: Hand-grip test and Chair stand test. The tool used for the hand-grip test is the GRIP-A (Takei). The…

Who can join

Women only · Ages 18 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

  • Patients attending the O.U. of Gynecology and Pathophysiology of Human Reproduction in menopause who take or do not take hormone replacement therapy at the time of visit as normal clinical practice and women in pre-menopause.
  • Patients for whom informed consent has been obtained.

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
Bologna IRCCS Azienda Ospedaliero-Universitaria Bologna Recruiting

Status & timeline

  • Overall status: Recruiting
  • Study type: Interventional
  • Phase: N/A
  • Start date: 2021-06-14
  • Primary completion: 2025-06-14
  • Last update posted: 2025-01-24
  • First posted: 2025-01-24

Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (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

  • Strength and muscle mass outcomes (From enrollment to the end of treatment (1 year))
    The primary objective is to compare the strength and muscle mass outcomes of HRT in menopausal women compared with those who do not use it and women in pre-menopausal age. Survey methods such as SARC-F, Handgrip test, Chair stand test and bio impedance will be used for this purpose.

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/NCT06792201 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.