An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause

Menopause Clinical Trial

Official title:

An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05617287
• Other study ID #: 20265
• Status: Completed
• Phase: N/A
• Start date: September 3, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: April 2023
• Source: Semaine Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A combination of synergistic dietary supplements is hypothesized to significantly improve self-reported measures of menopausal symptoms when compared with a baseline without the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 57 Years

Eligibility

Inclusion Criteria:

• Ability to take oral medication and be willing to adhere to the dietary supplement regimen (1 capsule per day)
• Moderate self-reported discomfort related to perimenopause or menopause. Participants will complete the menopause well-being survey and must answer an average of "moderate" or higher.

Exclusion Criteria:

• Current use of medication for high blood pressure or for blood thinning
• Currently undergoing chemotherapy or has previously been treated for cancer
• Pregnancy, breastfeeding, or attempting to become pregnant during the study
• Known allergic reactions to components of the dietary supplement (red clover extract, olive extract, bergamot extract )

Related Conditions & MeSH terms

• Menopause
• Menopause Related Conditions
• Perimenopausal Disorder

Intervention

Dietary Supplement:
• Semaine Menopause Supplement
Synergistic Dietary Supplement

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Semaine Health	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in perceived discomfort associated with the most common symptoms linked with perimenopause and menopause	Symptoms will be reported by the participant on a scale of perceived discomfort and will include rankings for mood, anxiety, fatigue, sleep quality, hot flashes, and libido.; This survey will be based on the widely used and validated Menopause Rating Scale (MRS). The MRS will be modified to increase dynamic range by changing the response gradations from 5 to 7.	12 weeks