Evaluating SE5-OH Tablets for Menopausal Symptoms in Healthy Women

Multicentre, Exploratory, Prospective, Open-labelled, Non-controlled Study to Evaluate the Effect of SE5-OH Tablets on Healthy Women With Menopausal Symptoms

This study is testing if SE5-OH tablets can help healthy women aged 45-60 feel better by reducing menopausal symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 45 Years to 60 Years
• Sex: Female
• Sponsor: Nutrition & Sante Iberia (industry)
• Locations: 1 site (Madrid)
• Trial ID: NCT06398236 on ClinicalTrials.gov

What this trial studies

This multicentre, exploratory study aims to assess the efficacy of SE5-OH tablets, a food supplement containing S-equol, in reducing menopausal symptoms in healthy women aged 45-60. The study will involve up to 300 participants across 10 hospitals in Spain, with a recruitment period of 6 months. Participants will receive the tablets for 12 weeks, followed by a 4-week follow-up period to evaluate symptom changes. The study will ensure that all candidates meet specific inclusion criteria and will provide detailed information about the investigational product before participation.

Who should consider this trial

Good fit: Ideal candidates are healthy women aged 45-60 who have been experiencing moderate to severe menopausal symptoms for at least one month.

Not a fit: Patients currently receiving hormone replacement therapy or with certain severe health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new non-hormonal treatment option for women experiencing menopausal symptoms.

How similar studies have performed: While this approach is exploratory, similar studies evaluating S-equol for menopausal symptoms have shown promise, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

* 45-60 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.
* Participation to another clinical trial.
* Any other medical problem identified by the investigator that could alter the ability of the volunteer to participate to the study including non-treated/non controlled thyroid disease, diabetes (among others).

  * A negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or HCG equivalent units) must be performed prior to subject enrolment and must be negative 24 hours prior to initiation of study treatment in case of any suspicious.

Where this trial is running

Madrid

• Clínica Palacios Madrid — Madrid, Spain (RECRUITING)

Study contacts

• Study coordinator: Kensaku SUGAYA

Conditions: Menopause