Open-labelled Study to Evaluate the Effect of SE5-OH Tablets on Healthy Women With Menopausal Symptoms
NCT06398236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170
Last updated 2025-07-08
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
Interventions
- DIETARY_SUPPLEMENT
-
SE5-OH tablets
SE5-OH (Fermented Soy germ, include S-equol), Crystalline cellulose, Oats fiber, Agar, Cyclic oligosaccharide, HPMC, Reduced syrup.
Sponsors & Collaborators
-
Adknoma Health Research
collaborator INDUSTRY -
Nutrition & Sante Iberia
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 45 Years
- Max Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-03-17
- Primary Completion
- 2024-07-18
- Completion
- 2024-10-16
Countries
- Spain
Study Locations
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