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

Not Applicable

Completed

• Conditions: Menopause Related Conditions; Perimenopausal Disorder; Menopause
• Interventions: Dietary Supplement: Semaine Menopause Supplement

• Registration Number: NCT05617287
• Lead Sponsor: Semaine Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-03
• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-15
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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 )

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Semaine Supplement	Semaine Menopause Supplement	Participants are provided with a dietary supplement and are instructed to take 1 capsule per day. Participants are to take the supplement at the same time every day. If forgotten, they are to take it with the next meal. Participants will take a well-being assessment after each month (4 surveys total including the baseline.)

Primary Outcome Measures

Name	Time	Method
Changes in perceived discomfort associated with the most common symptoms linked with perimenopause and menopause	12 weeks	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.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States