Safety and Efficacy of Dr. Tagliaferri's Menopause Formula

Inclusion Criteria:

1. Provide written informed consent.

2. Postmenopausal women aged 40-65 years.

3. Postmenopausal as defined by one of the following criteria:

1. 12 months of spontaneous amenorrhea;

2. 6 months of spontaneous amenorrhea with serum FSH >30 mIU/ml;

3. 6 weeks of surgical amenorrhea following bilateral oophorectomy with or without
hysterectomy; or

4. hysterectomy alone with serum FSH >30 mIU/ml.

4. During Screening, the patient must report they are having at least 5 moderate to
severe hot flashes per day or 35 moderate to severe hot flashes per week.

5. On the Screening Hot Flush Diary, demonstrate compliance (by indicating they filled
out the diary "all of the time" or "most of the time") on at least 4 out of 7 days.

6. Currently receive medical care from a health care provider.

Exclusion Criteria:

1. History of malignancy, with the exception of non-melanoma skin cancer or cervical
cancer that was diagnosed with treatment completion more than 1 year prior to
screening (i.e., if a participant had cervical cancer or basal cell carcinoma that
was diagnosed and fully treated 2 years prior to screening, the participant would be
eligible for the study).

2. Known carrier of BRCA1 or BRCA2.

3. Within 12 months of screening, abnormal mammogram or breast examination that is
suggestive of cancer, or refused mammogram or breast exam.

4. Within 12 months of screening, abnormal Pap smear or pelvic examination that is
suggestive of cancer, or refused Pap smear or pelvic exam.

5. Transvaginal Ultrasound (TVUS) double-wall endometrium of >8mm on TVUS.

6. Participants with polyps or other abnormal uterine masses (with the exception of
fibroids) on TVUS.

7. Unexplained uterine bleeding within six months prior to screening.

8. Clinical evidence of active ischemic cardiovascular disease or history of
cardiovascular disease.

9. Uncontrolled hypertension (≥160/100 at baseline or within 4 weeks prior to screening)
or a history of transient ischemic attack or cerebrovascular accidents.

10. History of deep vein thrombosis or pulmonary embolism.

11. Active liver disease or a history of impaired hepatic function.

12. History of chronic hepatitis B or C, hepatitis within the past 3 months, or HIV
infection.

13. History of severe chronic diarrhea, chronic constipation, uncontrolled irritable
bowel syndrome (IBS), uncontrolled inflammatory bowel disease (IBD), or unexplained
weight loss.

14. Active gallbladder disease.

15. Use of prescription medications known to be possibly effective for the treatment of
hot flushes within: 1 week prior to screening for vaginal hormonal products (rings,
creams, gels), 4 weeks prior to screening for transdermal estrogen alone or
estrogen/progestin products, 4 weeks prior to screening for testosterone products
(oral, patch, gel or cream), 8 weeks prior to screening for oral estrogen and/or
progestin therapy and intrauterine progestin therapy, 3 months prior to screening for
progestin implants and estrogen alone injectable drug therapy and 6 months prior to
screening for estrogen pellet therapy or progestin injectable drug therapy.

16. Use of herbal or dietary supplements purported to treat hot flushes or herbal/dietary
supplements with known estrogenic or progestogenic activity within 2 weeks of
screening.

17. Use of herbal or dietary supplements within 2 weeks prior to screening, unless the
participant agrees not to change the frequency or dose of the herbal supplement for
the entire duration of study treatment.

18. Currently taking morphine or other opiates on a chronic basis.

19. Any laboratory findings out of normal range deemed clinically significant.

20. BMI >35 kg/m2

21. History of substance abuse within the past year.

22. Use of another investigational agent within 1 month prior to screening.

23. History of severe food or medicine allergies resulting in anaphylactic shock,
requiring hospitalization, or requiring use of epinephrine.

24. Any concern or medical, emotional or psychiatric condition that, in the
investigator's opinion, would preclude the participant from providing informed
consent, completing questionnaires, adhering to the protocol or completing the trial
(e.g., severe illness, plans to move, substance abuse, significant psychiatric
problems, or dementia).