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

Sponsor
Semaine Health (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05617287
Collaborator
Citruslabs (Industry)
42
Enrollment
1
Location
1
Arm
3.9
Anticipated Duration (Months)
10.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Semaine Menopause Supplement
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause
Actual Study Start Date :
Sep 3, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Semaine 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.)

Dietary Supplement: Semaine Menopause Supplement
Synergistic Dietary Supplement

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 57 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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 )

Contacts and Locations

Locations

Site City State Country Postal Code
1 Citruslabs Santa Monica California United States 90404

Sponsors and Collaborators

  • Semaine Health
  • Citruslabs

Investigators

  • Principal Investigator: Christopher Hill, Citruslabs
  • Principal Investigator: Matthew Crane, Semaine Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Semaine Health
ClinicalTrials.gov Identifier:
NCT05617287
Other Study ID Numbers:
  • 20265
First Posted:
Nov 15, 2022
Last Update Posted:
Nov 15, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Semaine Health
Menopause
Perimenopause

Study Results

No Results Posted as of Nov 15, 2022