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OpenTrials
Completed

NCT Number: NCT05617287

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

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.

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Key information

Conditions

Menopause Menopause Related Conditions Perimenopausal Disorder

Age range

40 year–57 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Semaine Menopause Supplement

Dietary Supplement

Synergistic Dietary Supplement

Primary outcomes

  1. Changes in perceived discomfort associated with the most common symptoms linked with perimenopause and menopause

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Semaine Health

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 15, 2022
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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