Open-labelled Study to Evaluate the Effect of SE5-OH Tablets on Healthy Women With Menopausal Symptoms

NCT06398236 | Completed DMC

• 1 other identifier: EQUELLE_22_01
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Menopause

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of SE5-OH tablets on menopausal symptoms.

  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 the severity of the complaints perceived by the women completing the scale. The total score of the MRS ranges between 0 (asymptomatic) and 44 (highest degree of complaints) and is the sum of the dimension scores. The total score can be categorized into: No little (0-4) / Mild (5-8) / Moderate (9-15) / Severe (≥16). Higher scores mean worse outcome.

  At week 12 from week 0.

Secondary Outcomes (14)

• To evaluate the changes in menopausal symptoms.

  At week 4 and 16 from week 0.

• To evaluate the changes in vulvovaginal symptoms.

  At week 4, 12 and 16 from week 0.

• To evaluate the changes in work performance associated to menopausal symptoms.

  At week 12 from week 0.

• To evaluate the changes in pain in joint and hand, shoulder, and low back.

  At week 12 from week 0

• To evaluate the changes in sleep quality.

  At week 12 from week 0.

Study Arms (1)

SE5-OH tablets

EXPERIMENTAL

The product under investigation is a food supplement that contains SE5-OH (Fermented Soy germ, include S-equol), Crystalline cellulose, Oats fiber, Agar, Cyclic oligosaccharide, HPMC, Reduced syrup. The food supplement is presented in sealed bottles, each bottle contains 120 tablets with the recommended daily dose of 4 tablets per day administrated orally with a glass of water. The 4 tablets can be administrated together in a unique intake or in 2 separated intakes (2 tablets/intake) along the day.

Dietary Supplement: SE5-OH tablets

Interventions

SE5-OH tablets DIETARY_SUPPLEMENT

SE5-OH (Fermented Soy germ, include S-equol), Crystalline cellulose, Oats fiber, Agar, Cyclic oligosaccharide, HPMC, Reduced syrup.

SE5-OH tablets

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years healthy women who have provided signed ICF.
• Experiencing menopause symptoms for at least 1 month.
• MRS with a score equal or above 9 include women with moderate to severe menopausal symptoms according to the validated analysis of this questionnaire.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutrition & Sante Iberia: lead
• Adknoma Health Research: collaborator

Study Sites (1)

Clínica Palacios Madrid

Madrid, Madrid, Spain

Location

Related Publications (41)

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MeSH Terms

Interventions

SE5-OH

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: May 3, 2024
• Study Start: March 17, 2023
• Primary Completion: July 18, 2024
• Study Completion: October 16, 2024
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

ES (1)