Menopause, Menopause Related Conditions, Perimenopausal Disorder
Conditions
Keywords
Menopause, Perimenopause
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.
Interventions
DIETARY_SUPPLEMENTSemaine Menopause Supplement
Synergistic Dietary Supplement
Sponsors
Citruslabs
Semaine Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 57 Years
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 )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed