Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT05813067
Eligibility Criteria:
Inclusion Criteria:
1. Healthy menopausal women who are 40 to 65 years of age (inclusive).
2. Last menstrual period has occurred at least 6 months prior to screening.
3. MRS score ≥2 at screening and at baseline.
4. Have self-reported menopausal symptoms for the past 6 months.
5. Have self-reported at least five moderate to severe hot flashes per day (including night sweats), on average for 7 days
6. Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
7. In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
8. Have normal vital signs or acceptable to the investigator vital signs (blood pressure and heart rate) at screening.
9. Agree to refrain from treatments for hot flashes and other symptoms of menopause.
10. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
Exclusion Criteria:
1. Individuals who are lactating, pregnant or planning to become pregnant during the study.
2. Induced menopause through surgery such as bilateral oophorectomy or salpingo-oophorectomy, chemotherapy, radiation, or drugs.
3. Individuals who have had a partial or total hysterectomy.
4. Use of any treatment for menopausal symptoms or other concomitant treatments listed under the "concomitant therapies" section of the protocol
5. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
6. Received a vaccine for COVID-19 in the two weeks prior to screening or during the study period, current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually three months from the onset of COVID-19 with symptoms that last for at least two months and cannot be explained by an alternative diagnosis).
7. Have a positive medical history of heart disease, renal disease, hepatic impairment, or active systemic infection (e.g., lyme disease, TB, HIV).
8. Have uncontrolled high blood pressure (≥160 mmHg systolic or ≥100 mmHg diastolic) or thyroid disease, defined as not taking a stable dose of medication on the current regimen for a minimum of three months.
9. Have diabetes (Type I or Type II).
10. History of cancer (except localized skin cancer without metastases) within five (5) years prior to screening. Note: all women with breast cancer (active or any history) will be excluded.
11. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study, or influence the results or the potential subject's ability to participate in the study.
12. History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (i.e., Crohn's disease, short bowel, acute or chronic pancreatitis or pancreatic insufficiency).
13. Active vaginal infections/abnormalities (e.g., active urinary tract infection (UTI), genital hemorrhage of unknown origin, pelvic inflammatory disease (PID)). Note: screened participants with infections would be eligible to participate four weeks after completing their treatment (wash-out period).
14. Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
15. Major surgery in three months prior to screening or planned major surgery during the study.
16. History of a surgical procedure for the treatment of obesity (e.g., gastric bypass, gastric banding).
17. History of alcohol or substance abuse.
18. Receipt or use of test product(s) in another research study within 28 days prior to the baseline visit (Day 1), or longer if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
19. Use of any vaginal medications, rinses, moisturizers, cooling devices, cooling mattresses, cooling sprays, or patches purposed for hot flash control (i.e., V-cool patch, estrogen cream, etc.) one week before and during study.
20. Current or previous smoker in the last 3 years.
21. Any other active or unstable medical conditions or use of medications/supplements/ therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT05813067
Study Brief:
Protocol Section:
NCT05813067