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 range
40 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in frequency of moderate to severe hot flushes from baseline to 12 weeks.
. 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.
. Transvaginal Ultrasound (TVUS) double-wall endometrium of \>8mm on TVUS.
. Participants with polyps or other abnormal uterine masses (with the exception of fibroids) on TVUS.
. Unexplained uterine bleeding within six months prior to screening.
. Clinical evidence of active ischemic cardiovascular disease or history of cardiovascular disease.