Menopausal Symptoms, Menopause
Conditions
Keywords
Postmenopausal Women, Menopause-Related Quality of Life, Menopause Rating Scale, Cervantes Scale, Hot Flashes, Dietary Supplement
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTHIFAS 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.
Sponsors
Hifas da Terra S.L.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
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 hyperparathyroidism or hyperthyroidism. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in menopause-related quality of life assessed with the short-form Cervantes scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in menopausal symptom severity assessed with the menopause rating scale | Baseline and Weeks 4, 12, and 24 | 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. |
| Weekly hot flash frequency | Weeks 4, 12, and 24 | Number of hot flashes experienced per week, as recorded by participants in a study diary. |
| Change from baseline in difficulty concentrating assessed with the Visual Analog Scale for difficulty concentrating | Baseline and Weeks 4, 12, and 24 | 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. |
| Change from baseline in vulvovaginal health assessed with the Vaginal Health Index | Baseline and Weeks 4, 12, and 24 | Change from baseline in the total Vaginal Health Index score, used to assess clinical characteristics of vulvovaginal health. |
| Change from baseline in vaginal pH | Baseline and Weeks 4, 12, and 24 | Change from baseline in vaginal pH measured during the gynecological assessment. |
| Change from baseline in the percentage of superficial vaginal cells | Baseline and Week 24 | Change from baseline in the percentage of superficial vaginal epithelial cells determined through the cytological maturation assessment. |
| Change from baseline in the percentage of intermediate vaginal cells | Baseline and Week 24 | Change from baseline in the percentage of intermediate vaginal epithelial cells determined through the cytological maturation assessment. |
| Change from baseline in the percentage of basal and parabasal vaginal cells | Baseline and Week 24 | Change from baseline in the combined percentage of basal and parabasal vaginal epithelial cells determined through the cytological maturation assessment. |
| Number of participants with adverse events | From the first dose through Week 24 | 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. |
| Participant-reported tolerability of HIFAS MENOPAUSE assessed with the study-specific tolerability scale | Weeks 4, 12, and 24 | 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. |
| Participant satisfaction with HIFAS MENOPAUSE assessed with the study-specific satisfaction scale | Weeks 4, 12, and 24 | 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. |
| Treatment adherence | Weeks 4, 12, and 24 | Adherence to the prescribed regimen of two capsules once daily, assessed using returned study-product containers and study treatment records. |
Countries
Spain
Outcome results
None listed