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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06398236
• Other study ID #: EQUELLE_22_01
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Nutrition & Sante Iberia
• Contact: Kensaku SUGAYA
• Phone: +34 93 216 71 00
• Email: sugayaku[@]ns-group.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menopause

Intervention

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

Locations

Country	Name	City	State
Spain	Clínica Palacios Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Nutrition & Sante Iberia	Adknoma Health Research

Country where clinical trial is conducted

Spain, 

References & Publications (41)

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Setchell KD, Clerici C, Lephart ED, Cole SJ, Heenan C, Castellani D, Wolfe BE, Nechemias-Zimmer L, Brown NM, Lund TD, Handa RJ, Heubi JE. S-equol, a potent ligand for estrogen receptor beta, is the exclusive enantiomeric form of the soy isoflavone metabolite produced by human intestinal bacterial flora. Am J Clin Nutr. 2005 May;81(5):1072-9. doi: 10.1093/ajcn/81.5.1072. — View Citation

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the changes in menopausal symptoms.	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.
Secondary	To evaluate the changes in vulvovaginal symptoms.	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.
Secondary	To evaluate the changes in work performance associated to menopausal symptoms.	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.
Secondary	To evaluate the changes in pain in joint and hand, shoulder, and low back.	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
Secondary	To evaluate the changes in sleep quality.	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.
Secondary	To evaluate the changes in vasomotor symptoms.	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.
Secondary	To evaluate the changes in the vaginal maturation index.	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.
Secondary	To evaluate the changes in the vaginal pH.	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.
Secondary	To evaluate the changes in body mass index (BMI).	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.
Secondary	To evaluate the changes in blood pressure (BP).	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
Secondary	To evaluate the variability of equol producers and equol non-producers among the subjects.	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
Secondary	To evaluate the adverse events.	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.
Secondary	To evaluate tolerability.	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
Secondary	To evaluate the compliance.	Compliance (in terms of poor, moderate good and very good) during the 12 weeks of treatment administration.	At week 12