CompletedNot Applicable

Effect of HIFAS MENOPAUSE on Quality of Life in Postmenopausal Women

Spain20 participantsStarted 2025-02-14

Plain-language summary

This single-center, single-group, open-label study evaluated changes in menopause-related quality of life and menopausal symptoms in postmenopausal women aged 40 to 60 years after 24 weeks of treatment with HIFAS MENOPAUSE. Participants took two capsules of HIFAS MENOPAUSE orally once daily while fasting for 24 weeks. Study assessments were performed at baseline and after 4, 12, and 24 weeks of treatment. The primary objective was to evaluate change in menopause-related quality of life using the short-form Cervantes Scale. Additional assessments included menopausal symptom severity, weekly hot-flash frequency, difficulty concentrating, vulvovaginal health, vaginal pH, cytological maturation, treatment adherence, tolerability, satisfaction, and adverse events.

Who can participate

Age range

40 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Postmenopausal women, defined as having had their last menstrual period at least 12 months before screening. * Age 40 to 60 years, inclusive. * Vaginal pH ≥5. * Menopause Rating Scale (MRS) total score ≥20. * Willing and able to provide written informed consent, take HIFAS MENOPAUSE, complete the study questionnaires, records, and diaries, and attend all scheduled study visits. * Willing to discontinue prebiotic supplements and foods containing added prebiotics or live and active cultures for a 4-week washout period before enrollment. Exclusion Criteria: * Menopause induced by total or partial hysterectomy, chemotherapy, or radiotherapy. * Use of natural health products intended to treat menopausal symptoms, including phytoestrogens, black cohosh, dehydroepiandrosterone (DHEA), dong quai, vitamin E at doses greater than 250 IU/day, or high consumption of soy-based foods, unless the required washout period had been completed. * Current or previous menopausal hormone therapy for menopausal symptoms, unless the required washout period had been completed. * Acute vaginal infection, urinary tract infection, genital bleeding of unknown origin, or another clinically relevant gynecological condition. * Use of vaginal medications, vaginal douches, moisturizers, or gels containing lidocaine or other analgesic products intended to reduce pain during sexual intercourse within 1 week before enrollment or during the study. * Previous diagnosis of hyperparathyroidis…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in menopause-related quality of life assessed with the short-form Cervantes scale

Timeframe: Baseline and Weeks 4, 12, and 24

Trial details

NCT IDNCT07752641

SponsorHifas da Terra S.L.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-14

View on ClinicalTrials.gov More Menopause trials