Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398236
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-09
Brief Title:
Open-labelled Study to Evaluate the Effect of SE5-OH Tablets on Healthy Women With Menopausal Symptoms
Sponsor:
Nutrition Sante Iberia
Organization:
Nutrition Sante Iberia
Study Overview
Official Title:
Multicentre Exploratory Prospective Open-labelled Non-controlled Study to Evaluate the Effect of SE5-OH Tablets on Healthy Women With Menopausal Symptoms
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 upend of study visit FUEoS 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
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 upend of study visit FUEoS 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None