An interventional study of HIFAS MENOPAUSE in Menopause and Menopausal Symptoms, sponsored by Hifas da Terra S.L.. Completed at 1 site in Spain. Open to female participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Hifas da Terra S.L. · Not applicable, Interventional, and Treatment
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.
This was a prospective, single-center, single-group, open-label, pre-post interventional study conducted in postmenopausal women with mild to moderate menopausal symptoms. The study included no concurrent control group, and each participant served as her own control.
Eligible participants were postmenopausal women aged 40 to 60 years whose last menstrual period had occurred at least 12 months before screening. Participants received HIFAS MENOPAUSE, a dietary supplement, at a dose of two oral capsules once daily while fasting for 24 weeks.
Study visits were conducted at the following time points:
Baseline, before starting treatment Week 4 Week 12 Week 24
Menopause-related quality of life was assessed using the short-form Cervantes Scale. Menopausal symptom severity was evaluated using the Menopause Rating Scale. Other assessments included weekly hot-flash frequency recorded in a participant diary, difficulty concentrating measured using a visual analog scale, vaginal pH, the Vaginal Health Index, and the cytological maturation index.
Adverse events and concomitant treatments were recorded during follow-up. Treatment adherence, tolerability, and participant satisfaction were also evaluated. Changes observed at weeks 4, 12, and 24 were compared with baseline measurements. The final study assessment was performed at week 24.
339 studies on the registry are indexed under Hot Flashes; 56 are open to participants now.
This study's enrollment of 20 is below the median of 90 across 306 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →Hifas da Terra S.L. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received HIFAS MENOPAUSE, a symbiotic dietary supplement, at a dose of two capsules orally once daily while fasting for 24 weeks. Outcomes were assessed at baseline and at weeks 4, 12, and 24. No concurrent comparator or control arm was included.
Dietary Supplement: HIFAS MENOPAUSE
HIFAS MENOPAUSE is a symbiotic dietary supplement administered as two oral capsules once daily while fasting for 24 weeks. Each daily dose contained Hericium erinaceus fruiting body powder 280 mg, Cordyceps sinensis mycelial extract 240 mg, Ganoderma lucidum fruiting body extract 100 mg, ashwagandha root extract 100 mg, green tea leaf extract 100 mg, a probiotic blend containing Bifidobacterium lactis, Lactobacillus plantarum, Bifidobacterium infantis, Lactobacillus acidophilus, and Bifidobacterium longum, as well as zinc, vitamin B6, vitamin A, and vitamin D. The study product was provided by Hifas da Terra, S.L.
Change from baseline in menopause-related quality of life assessed with the short-form Cervantes scale
Change from baseline in the total score of the 16-item short-form Cervantes Scale, used to assess menopause-related quality of life. The total score ranges from 0 (minimum) to 80 (maximum). Higher scores indicate a greater negative impact of menopause on quality of life, representing a worse outcome. Therefore, a decrease from baseline indicates improvement.
Time frame: Baseline and Weeks 4, 12, and 24
Change from baseline in menopausal symptom severity assessed with the menopause rating scale
Change from baseline in the total Menopause Rating Scale score. The scale contains 11 items scored from 0, no symptoms, to 4, very severe symptoms. The minimum total score is 0 and the maximum total score is 44. Higher scores indicate greater menopausal symptom severity and therefore a worse outcome. A decrease from baseline indicates improvement.
Time frame: Baseline and Weeks 4, 12, and 24
Weekly hot flash frequency
Number of hot flashes experienced per week, as recorded by participants in a study diary.
Time frame: Weeks 4, 12, and 24
Change from baseline in difficulty concentrating assessed with the Visual Analog Scale for difficulty concentrating
Change from baseline in participant-reported difficulty concentrating, assessed using the Visual Analog Scale for Difficulty Concentrating. The scale ranges from 0 (minimum; best state/no difficulty) to 10 (maximum; worst state). Higher scores indicate greater difficulty concentrating and therefore a worse outcome. A decrease from baseline indicates improvement.
Time frame: Baseline and Weeks 4, 12, and 24
Change from baseline in vulvovaginal health assessed with the Vaginal Health Index
Change from baseline in the total Vaginal Health Index score, used to assess clinical characteristics of vulvovaginal health.
Time frame: Baseline and Weeks 4, 12, and 24
Change from baseline in vaginal pH
Change from baseline in vaginal pH measured during the gynecological assessment.
Time frame: Baseline and Weeks 4, 12, and 24
Change from baseline in the percentage of superficial vaginal cells
Change from baseline in the percentage of superficial vaginal epithelial cells determined through the cytological maturation assessment.
Time frame: Baseline and Week 24
Change from baseline in the percentage of intermediate vaginal cells
Change from baseline in the percentage of intermediate vaginal epithelial cells determined through the cytological maturation assessment.
Time frame: Baseline and Week 24
Change from baseline in the percentage of basal and parabasal vaginal cells
Change from baseline in the combined percentage of basal and parabasal vaginal epithelial cells determined through the cytological maturation assessment.
Time frame: Baseline and Week 24
Number of participants with adverse events
Number of participants who experienced one or more adverse events during treatment with HIFAS MENOPAUSE. Adverse events and concomitant treatments were recorded at each post-baseline study visit.
Time frame: From the first dose through Week 24
Participant-reported tolerability of HIFAS MENOPAUSE assessed with the study-specific tolerability scale
Participant-reported tolerability of HIFAS MENOPAUSE, assessed using the study-specific tolerability scale. The scale ranges from 1 (minimum; no problems with treatment/excellent tolerability) to 5 (maximum; too many problems with treatment/very poor tolerability). Higher scores indicate worse tolerability and therefore a worse outcome.
Time frame: Weeks 4, 12, and 24
Participant satisfaction with HIFAS MENOPAUSE assessed with the study-specific satisfaction scale
Participant-reported satisfaction with HIFAS MENOPAUSE, assessed using the study-specific satisfaction scale. The scale ranges from 1 (minimum; not at all satisfied) to 7 (maximum; very satisfied), with a score of 4 corresponding to no change. Higher scores indicate greater satisfaction and therefore a better outcome.
Time frame: Weeks 4, 12, and 24
Treatment adherence
Adherence to the prescribed regimen of two capsules once daily, assessed using returned study-product containers and study treatment records.
Time frame: Weeks 4, 12, and 24
Plan to share: No — No individual participant data will be made available. The study protocol did not establish a prospective plan, repository, data dictionary, access criteria, or governance process for sharing participant-level data with external researchers. Study data will be maintained confidentially and handled in accordance with applicable data-protection requirements. Only aggregate, non-identifiable study results may be reported.
No publications or documents are linked to this record.
Ran from Feb 2025 to primary completion in Jan 2026, 11 months.
Of 65 interventional studies with no phase under Hot Flashes, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's 11 months is below that.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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