Clinical trial NCT06398236: Open-labelled Study to Evaluate the Effect of SE5-OH Tablets on Healthy Women With Menopausal Symptoms
Official title: Multicentre, Exploratory, Prospective, Open-labelled, Non-controlled Study to Evaluate the Effect of SE5-OH Tablets on Healthy Women With Menopausal Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Menopause
Lead sponsor: Nutrition & Sante Iberia
Sponsor class: INDUSTRY
Collaborators: name: Adknoma Health Research
First posted: 2024-05-03
Enrollment: 300
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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.

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).

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.

Primary outcomes:
measure: To evaluate the efficacy of SE5-OH tablets on menopausal symptoms.
timeFrame: At week 12 from week 0.
Secondary outcomes:
measure: To evaluate the changes in menopausal symptoms.
timeFrame: At week 4 and 16 from week 0.
measure: To evaluate the changes in vulvovaginal symptoms.
timeFrame: At week 4, 12 and 16 from week 0.
measure: To evaluate the changes in work performance associated to menopausal symptoms.
timeFrame: At week 12 from week 0.
measure: To evaluate the changes in pain in joint and hand, shoulder, and low back.
timeFrame: At week 12 from week 0
measure: To evaluate the changes in sleep quality.
timeFrame: At week 12 from week 0.
measure: To evaluate the changes in vasomotor symptoms.
timeFrame: At week 4, 12 and 16 from week 0 based on daily registrations.
measure: To evaluate the changes in the vaginal maturation index.
timeFrame: At week 4, 12 and 16 from week 0.
measure: To evaluate the changes in the vaginal pH.
timeFrame: At week 4, 12 and 16 from week 0.
measure: To evaluate the changes in body mass index (BMI).
timeFrame: At week 12 from week 0.
measure: To evaluate the changes in blood pressure (BP).
timeFrame: At week 16
measure: To evaluate the variability of equol producers and equol non-producers among the subjects.
timeFrame: At week 16
measure: To evaluate the adverse events.
timeFrame: Up to 16 weeks.
measure: To evaluate tolerability.
timeFrame: At week 16
measure: To evaluate the compliance.
timeFrame: At week 12
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clínica Palacios Madrid
Study officials:
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