Status:
COMPLETED
A Study to Examine the Effects of a Daily Supplement on Common Symptoms of Perimenopause and Menopause
Lead Sponsor:
Hologram Sciences
Collaborating Sponsors:
Citruslabs
Conditions:
Menopause
Perimenopause
Eligibility:
FEMALE
40-65 years
Phase:
NA
Brief Summary
Symptoms of perimenopause and menopause can significantly affect overall quality of life. It is hypothesized that daily supplements can reduce the severity of these symptoms. This 12-week clinical tri...
Eligibility Criteria
Inclusion
- Women aged 40-65 years old Must be experiencing at least two symptoms of menopause, such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, irregular or absent periods, or vaginal changes Must experience hot flashes and/or night sweats at least 5 times per day Can be either natural or surgical menopause (or perimenopause) Willing to adhere to the study protocol for the duration of the study
- Willing to consult with their physician prior to starting the trial if taking any of the following medications:
- Levothyroxine Liothyronine Calcipotriene (Dovonex) Digoxin (Lanoxin) Diltiazem (Cardizem) Verapamil (Calan, others) Thiazide diuretics Atorvastatin (Lipitor) Warfarin - Might increase the amount of time it takes for blood clotting. Minosalicylic acid (Paser) Colchicine (Colcrys, Mitigare, Gloperba) Metformin (Glumetza, Fortamet, others) Proton pump inhibitors (omeprazole (Prilosec), lansoprazole (Prevacid) or other stomach acid-reducing drugs) Phenytoin (Dilantin) Antihypertensive drugs Phenobarbital (Luminal) Amiodarone (Cordarone) Levodopa
Exclusion
- Not experiencing hot flashes and/or night sweats at least 5 times per day Has taken herbal supplements or multivitamins within the last 1 month Current use of conventional hormone replacement therapies, or plan to start during the study duration Current use of hormonal birth control, or plan to start during the study duration Known allergies to any product ingredients including the purified isoflavone genistein History of uterine fibroids, endometriosis, polycystic ovarian syndrome, or history of abnormal pap smear Anyone with any known severe allergies requiring the use of an epi-pen Unwilling to adhere to the study protocol Anyone living with uncontrolled or chronic health disorders, including oncological or psychiatric disorders No planned invasive medical procedures for the duration of the study Pregnant or breastfeeding
Key Trial Info
Start Date :
August 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06018740
Start Date
August 14 2023
End Date
November 13 2023
Last Update
February 29 2024
Active Locations (1)
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1
Citruslabs
Santa Monica, California, United States, 90404