Clinical Trial 55700

Birmingham, AL 35205


Summary:

Are you experiencing hot flashes during post-menopause and between the ages of 40 and 65? Alabama Clinical Therapeutics is conducting a study on a new, hormone-free natural supplement aimed at reducing hot flash symptoms. This hybrid study involves three in-person visits and three virtual ones, with flexible scheduling to accommodate your lifestyle. Participants will receive compensation for their time and travel expenses. If you're interested in a drug-free approach to managing your symptoms, consider joining our study. For more information, please contact us.



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. Have self-reported menopausal symptoms for the past 6 months.
  4. Have self-reported 5 moderate to severe hot flashes per day (including night sweats), on average for 7 days
  5. Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
  6. In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
  7. Have normal vital signs or acceptable to the investigator vital signs (blood pressure and heart rate) at screening.
  8. Agree to refrain from treatments listed in Section 6.5 in the defined timeframe.
  9. 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. Have diabetes (Type I or Type II)
  4. 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
  5. Current use of hormone therapies prohibited within 12 weeks prior to the start of the study


Qualified Participants May Receive:

Compensation for time and travel.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.