What this trial studies
Multicentre, exploratory, prospective, open-labelled study to evaluate the efficacy of SE5-OH tablets on menopausal symptoms in healthy women experiencing menopausal symptoms after 12 weeks of administration. The study will be performed in 10 hospitals (private and public) located in Spain. Recruitment period of 6 months will be defined in order to include up to 300 healthy volunteers from different national hospitals and clinics.
Conditions in scope
- Menopause
Interventions
- SE5-OH tablets (Dietary Supplement) — SE5-OH (Fermented Soy germ, include S-equol), Crystalline cellulose, Oats fiber, Agar, Cyclic oligosaccharide, HPMC, Reduced syrup.
Who can join
Women only · Ages 45 Years to 60 Years · Accepts healthy volunteers.
Inclusion criteria
- years healthy women who have provided signed ICF.
- Experiencing menopause symptoms for at least 1 month.
- Total MRS score ≥9 at inclusion time (baseline).
- MRS with a score equal or above 9 include women with moderate to severe menopausal symptoms according to the validated analysis of this questionnaire.
Exclusion criteria
- Women currently receiving hormone replacement therapy (HRT) or bio identical hormone replacement therapy (BHRT) or have received HRT/BHRT in the last 3 months.
- Pregnant, nursing women or women planning to become pregnant*.
- Subject with a history or presence of clinically severe disease such as hepatic, renal, endocrine, hematologic, immunologic (including chronic inflammatory conditions) and cancer disease.
- History or presence psychosomatic diseases (drug treatment), epilepsy, rheumatism.
- Allergies to soy.
- History of any food behaviour complication (lacking sufficient intake and/or over intake of food)
- Intestinal malabsorption that could decrease food supplements intestinal absorption.
- Receiving any drug during the last 3 months for menopause symptoms or any food supplement during the last 1 month that could decrease or hide/mask the effect of the experimental product.
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Madrid | Madrid | Clínica Palacios Madrid | Unknown |
Status & timeline
- Overall status: Completed
- Study type: Interventional
- Phase: N/A
- Start date: 2023-03-17
- Primary completion: 2024-07-18
- Last update posted: 2025-07-08
- First posted: 2024-05-03
Sponsor & contact
Lead sponsor: Nutrition & Sante Iberia (Industry)
Collaborators: Adknoma Health Research
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- To evaluate the efficacy of SE5-OH tablets on menopausal symptoms. (At week 12 from week 0.)
To evaluate the efficacy of SE5-OH tablets on menopausal symptoms with the assessment of the menopausal rating scale (MRS) total scores and subscales scores (somatic, psychological, and urogenital) after 12 weeks of treatment from week 0. MRS consists of a list of 11 symptoms, that can get 0 (no symptom) or up to 4 scoring points (severe symptom) depending on…
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT06398236 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.