Effect of HIFAS MENOPAUSE on Quality of Life in Postmenopausal Women

Completed · Not applicable

Conditions studied: Menopause, Menopausal Symptoms

In brief

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.

Key facts

Study ID

NCT07752641

Run by

Hifas da Terra S.L.

People needed

20

Starts

2025-02-14

Expected to finish

2026-01-14

Last updated by the study team

2026-08-07

Who can join

Age: 40 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Instituto Palacios, Salud y Medicina de la Mujer — Madrid, Madrid, Spain

Full record on ClinicalTrials.gov

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