Safety and Efficacy of Dr. Tagliaferri's Menopause Formula (NCT01957306) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of Dr. Tagliaferri's Menopause Formula
United States30 participantsStarted 2013-11
Plain-language summary
The primary goal of this study is to evaluate the safety and efficacy of 12 weeks of treatment of 4 grams/day of Dr. Tagliaferri's Menopause Formula (administered as 2 grams PO BID) in reducing the frequency of menopausal vasomotor symptoms among healthy, postmenopausal women, aged 40-65, with moderate to severe hot flushes.
Who can participate
Age range40 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. Provide written informed consent.
✓. Postmenopausal women aged 40-65 years.
✓. Postmenopausal as defined by one of the following criteria:
✓. 12 months of spontaneous amenorrhea;
✓. 6 months of spontaneous amenorrhea with serum FSH \>30 mIU/ml;
✓. 6 weeks of surgical amenorrhea following bilateral oophorectomy with or without hysterectomy; or
✓. hysterectomy alone with serum FSH \>30 mIU/ml.
✓. 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.
Exclusion criteria
✕. 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).
✕. Known carrier of BRCA1 or BRCA2.
✕. Within 12 months of screening, abnormal mammogram or breast examination that is suggestive of cancer, or refused mammogram or breast exam.
✕. Within 12 months of screening, abnormal Pap smear or pelvic examination that is suggestive of cancer, or refused Pap smear or pelvic exam.
What they're measuring
1
Change in frequency of moderate to severe hot flushes from baseline to 12 weeks.