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

July 2, 2025 updated by: Nutrition & Sante Iberia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Multicentre, exploratory, prospective, open-labelled, non-controlled study to evaluate the efficacy of SE5-OH tablets for menopausal symptoms reduction. SE5-OH tablets are a food supplement containing active S-equol. The daily dose of S-equol is 10 mg in the form of 4 tablets of SE5-OH tablets.

The study will be performed in 10 hospitals (private and public) located in Spain to include up to 300 subjects in 6 months of recruitment period.

Investigators will review the medical history from healthy women with moderate to severe menopausal symptoms who are visiting the participating site, investigators will ensure that each candidate meets all the inclusion criteria and none of exclusion criteria. Suitable participants will be informed during the visit about the nature of the investigational study by receiving first information about the investigational product (food supplement) and invited to participate later when all questions have been addressed. A 14 days' period of reflexion is possible for every participant in accordance with Good Clinical Practice.

The procedures involved will be explained in detail and written consent must be obtained with subject and investigators signature before subject participation. The total duration of each participant in the study will be 16 weeks (12 weeks treatment + 4 weeks follow up). The participation in the study is completely voluntary.

The study consists of 4 visits: 3 visits until the end of treatment (EoT) with 1 follow up/end of study visit (FU/EoS) after treatment completion.

SE5-OH tablets will be administrated in tablets (4 per day) by daily oral intake until the day before the end of treatment date (week 12). Non-administrated SE5-OH tablets and VMS diary competition will be verified during the study in the corresponding visits until the EoS (visit 4).

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Clínica Palacios Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SE5-OH tablets
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
SE5-OH (Fermented Soy germ, include S-equol), Crystalline cellulose, Oats fiber, Agar, Cyclic oligosaccharide, HPMC, Reduced syrup.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy of SE5-OH tablets on menopausal symptoms.
Time Frame: 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 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the changes in menopausal symptoms.
Time Frame: At week 4 and 16 from week 0.

To evaluate the changes in menopausal symptoms by MRS total scores and subscales scores (somatic, psychological, and urogenital) at week 4 and 16 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 4 and 16 from week 0.
To evaluate the changes in vulvovaginal symptoms.
Time Frame: At week 4, 12 and 16 from week 0.

To evaluate the changes in vulvovaginal symptoms by the vulvovaginal symptoms questionnaire (VSQ) total score and subscales score (symptoms, emotions, life-impact, and sexual impact) at week 4, 12 and 16 from week 0.

VSQ consists of a list of 21 items answered as yes (1 point) or no (0 points), and making up a total of four scales:

  • Vulvovaginal symptoms: 0 to 7 points (items 1-7)
  • Emotions: 0 to 4 points (items 8-11)
  • Life-impact: 0 to 4 points (items 12-15)
  • Sexual impact: 0 to 5 points (items 16, 18-21) [item 17 asks about sexual activity, if the answer is affirmative then the four scales are evaluated, if it is negative, only the first three] The total score of the VSQ ranges between 0 and 20: the higher the score, the worse the rating
At week 4, 12 and 16 from week 0.
To evaluate the changes in work performance associated to menopausal symptoms.
Time Frame: At week 12 from week 0.

To evaluate the changes in work performance associated to menopausal symptoms, the utrecht work engagement scale (UWES) total scores and subscales scores (vigor, dedication, and absorption) at week 12 from week 0.

UWES consists of a list of 17 items, that can get 0 (never) or up to 6 scoring points (always / every day). There are 3 scales:

  • Vigor (item 1, 4, 8, 12, 15, 17)
  • Dedication (item 2, 5, 7, 10, 13)
  • Absorption (item 3, 6, 9, 11, 14, 16) The mean scale score of the three UWES subscales is computed by adding the scores on the particular scale and dividing the sum by the number of items of the subscale involved. A similar procedure if followed for the total score. Hence, the UWES, yields three subscale scores and/or a total score that range between 0 and 6: the higher score, the most work engagement.
At week 12 from week 0.
To evaluate the changes in pain in joint and hand, shoulder, and low back.
Time Frame: At week 12 from week 0
To evaluate the changes in pain in joint and hand, shoulder, and low back by the visual analogue scale (VAS) at week 12 from week 0. Each visual analogue scale scores from 0 to 10. Higher scores mean worse outcome.
At week 12 from week 0
To evaluate the changes in sleep quality.
Time Frame: At week 12 from week 0.

To evaluate the changes in sleep quality by the visual analogue scale (VAS) at week 12 from week 0.

Visual analogue scale scores from 0 to 10. Higher scores mean worse outcome.
At week 12 from week 0.
To evaluate the changes in vasomotor symptoms.
Time Frame: At week 4, 12 and 16 from week 0 based on daily registrations.

To evaluate the changes in vasomotor symptoms (VMS) such hot flushes and night sweats, a registration of frequency and severity every day during the 16 weeks of subject participation.

The mean number of hot flashes/night sweats by severity (mild, moderate, and severe) reported in the diary will be calculated in each study period.
At week 4, 12 and 16 from week 0 based on daily registrations.
To evaluate the changes in the vaginal maturation index.
Time Frame: At week 4, 12 and 16 from week 0.

To evaluate the changes in the vaginal maturation index (VMI) by pap smear at week 4, 12 and 16 from week 0.

The VMI is presented as 0/0/0, representing respectively: % parabasal cells, % intermediate cells and % superficial cells.

The VMI is the ratio of different cell types in the vaginal wall (parabasal, intermediate and superficial cells) the presence of one and another type is influenced by oestrogen and progesterone stimulation, which means, that VMI will change throughout a woman's life depending on age and/or reproductive stage. Vaginal pH >5 seems to be associated to dryness and mucosal pallor; hormonal changes could affect either to vaginal pH and vaginal epithelium resulting in signs and symptoms of dryness or dyspareunia among others. Weber et al. concluded in their study that objective assessments such VMI and vaginal pH should be evaluated in conjunction with subjective assessments.
At week 4, 12 and 16 from week 0.
To evaluate the changes in the vaginal pH.
Time Frame: At week 4, 12 and 16 from week 0.
To evaluate the changes in the vaginal pH (VpH) by a pH determination at week 4, 12 and 16 from week 0.
At week 4, 12 and 16 from week 0.
To evaluate the changes in body mass index (BMI).
Time Frame: At week 12 from week 0.
To evaluate the changes in body mass index (BMI) at week 12 from week 0. Weight and height will be combined to report BMI in kg/m^2
At week 12 from week 0.
To evaluate the changes in blood pressure (BP).
Time Frame: At week 16
To evaluate the changes in blood pressure (BP) at week 12 from week 0. Systolic and Diastolic Blood Pressure will be reported in mmHg.
At week 16
To evaluate the variability of equol producers and equol non-producers among the subjects.
Time Frame: At week 16

Equol producers vs non-equol producers will be described at week 16 by means of results from urine analysis:

  • S-equol concentration
  • Daidzein concentration
  • S-equol/daidzein Log10 The patients will be classified into equol producer / non-producer / indeterminate, considering that daidzein ratio of -1.75 provided a demarcation to define equol producer status.
At week 16
To evaluate the adverse events.
Time Frame: Up to 16 weeks.
Adverse events (in terms of severity, intensity, causal relationship and outcome) will be assessed during the 16 weeks of study participation.
Up to 16 weeks.
To evaluate tolerability.
Time Frame: At week 16
The perception of tolerability by subject and investigator will be described at week 16. It will be measured with the folowing scale: excelent/good/moderate/poor/not evaluated by each one of them.
At week 16
To evaluate the compliance.
Time Frame: At week 12
Compliance (in terms of poor, moderate good and very good) during the 12 weeks of treatment administration.
At week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutrition & Sante Iberia

Collaborators

Adknoma Health Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2023

Primary Completion (Actual)

July 18, 2024

Study Completion (Actual)

October 16, 2024

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • EQUELLE_22_01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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