MenopauseNCT07752641
Effect of HIFAS MENOPAUSE on Quality of Life in Postmenopausal Women
A study testing HIFAS MENOPAUSE in people with Menopause and Menopausal Symptoms, run by Hifas da Terra S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Menopause, Menopausal Symptoms
- What is being tested?
- HIFAS MENOPAUSE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 14 Feb 2025to 14 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 hyperparathyroidism or hyperthyroidism.
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- Participation in another clinical study within the previous 6 months.
- History of alcohol or drug abuse within the 12 months before screening.
- History of cancer within 5 years before screening, except localized nonmetastatic skin cancer.
- History of any clinically significant disease or disorder that, in the investigator's opinion, could place the participant at risk, affect the study results, or impair the participant's ability to complete the study.
- History or presence of gastrointestinal, hepatic, or renal disease, or another condition known to interfere with the absorption, distribution, metabolism, or excretion of medicinal products, including Crohn disease, short bowel syndrome, acute or chronic pancreatitis, or pancreatic insufficiency.
- History of bariatric surgery, including gastric bypass or gastric banding.
- Current consumption of more than two standard alcoholic drinks per day. One standard drink was defined as 355 mL of beer, 150 mL of wine, or 45 mL of spirits.
- Difficulty swallowing large tablets or a large number of tablets.
- Any condition or abnormality that, in the investigator's opinion, could compromise participant safety or the quality of the study data.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto Palacios, Salud y Medicina de la Mujer
Madrid, Madrid, 28009
About this study
Official title: Evaluación de la Eficacia Del Uso de "HIFAS MENOPAUSE" en la Calidad de Vida de Mujeres Postmenopáusicas
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.
Read the detailed description
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.
- Conditions
- Menopause, Menopausal Symptoms
- Being tested
- HIFAS MENOPAUSE
- Keywords
- Postmenopausal Women, Menopause-Related Quality of Life, Menopause Rating Scale, Cervantes Scale, Hot Flashes, Dietary Supplement
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFAS MENOPAUSEDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| HIFAS MENOPAUSE | Experimental | 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. Receives: Dietary Supplement: HIFAS MENOPAUSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Weeks 4, 12, and 24
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Weeks 4, 12, and 24
Change from baseline in vaginal pH
Change from baseline in vaginal pH measured during the gynecological assessment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 4, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start14 Feb 2025
- Primary completion14 Jan 2026
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received HIFAS MENOPAUSE, two capsules orally once daily while fasting for 24 weeks. Outcomes were assessed at baseline and at weeks 4, 12, and 24. Each participant served as her own control, and no concurrent comparator group was included.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hifas da Terra S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752641
- Sponsor's protocol ID
- Hifas 2024-002
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluación de la Eficacia Del Uso de "HIFAS MENOPAUSE" en la Calidad de Vida de Mujeres Postmenopáusicas
- ClinicalTrials.gov ID
- NCT07752641
- Acronym / sponsor ID
- Hifas 2024-002
- Conditions
- Menopause, Menopausal Symptoms
- Keywords
- Postmenopausal Women, Menopause-Related Quality of Life, Menopause Rating Scale, Cervantes Scale, Hot Flashes, Dietary Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hifas da Terra S.L.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received HIFAS MENOPAUSE, two capsules orally once daily while fasting for 24 weeks. Outcomes were assessed at baseline and at weeks 4, 12, and 24. Each participant served as her own control, and no concurrent comparator group was included.
| Arm | Type | Receives |
|---|---|---|
| HIFAS MENOPAUSE | Experimental | Dietary Supplement: HIFAS MENOPAUSEParticipants 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIFAS MENOPAUSEHIFAS 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. | Dietary supplement | HIFAS MENOPAUSE |
Primary outcome
Change from baseline in menopause-related quality of life assessed with the short-form Cervantes scale
Time frame: Baseline and Weeks 4, 12, and 24
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.
12 secondary outcomes
Change from baseline in menopausal symptom severity assessed with the menopause rating scale
Time frame: Baseline and Weeks 4, 12, and 24
Weekly hot flash frequency
Time frame: Weeks 4, 12, and 24
Change from baseline in difficulty concentrating assessed with the Visual Analog Scale for difficulty concentrating
Time frame: Baseline and Weeks 4, 12, and 24
Change from baseline in vulvovaginal health assessed with the Vaginal Health Index
Time frame: Baseline and Weeks 4, 12, and 24
Change from baseline in vaginal pH
Time frame: Baseline and Weeks 4, 12, and 24
Change from baseline in the percentage of superficial vaginal cells
Time frame: Baseline and Week 24
Change from baseline in the percentage of intermediate vaginal cells
Time frame: Baseline and Week 24
Change from baseline in the percentage of basal and parabasal vaginal cells
Time frame: Baseline and Week 24
Number of participants with adverse events
Time frame: From the first dose through Week 24
Participant-reported tolerability of HIFAS MENOPAUSE assessed with the study-specific tolerability scale
Time frame: Weeks 4, 12, and 24
Participant satisfaction with HIFAS MENOPAUSE assessed with the study-specific satisfaction scale
Time frame: Weeks 4, 12, and 24
Treatment adherence
Time frame: Weeks 4, 12, and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFAS MENOPAUSE in people with Menopause and Menopausal Symptoms, run by Hifas da Terra S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in menopause-related quality of life assessed with the short-form Cervantes scale (time frame: Baseline and Weeks 4, 12, and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.