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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dr. Tagliaferri's Menoapause Formula | Experimental | Administered as 2 grams PO BID. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dr. Tagliaferri's Menopause Formula | Dietary Supplement | Administered as 2 grams PO BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency of moderate to severe hot flushes from baseline to 12 weeks. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events assessment | 12 weeks | |
| Change in the frequency of hot flushes that awake participants during sleep | 12 weeks | |
| Change in frequency of moderate to severe hot flushes from baseline to week 4 |
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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:
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.
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.
Currently receive medical care from a health care provider.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Koltun, MD | Medical Center for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 4 weeks |
| Change in severity of moderate to severe hot flushes from baseline to week 4 | 4 weeks |
| Change in severity of moderate to severe hot flushes from baseline to week 12 | 12 weeks |
| The clinical meaningfulness of the reduction in hot flashes | At the end of 12 weeks of treatment in the Phase 2 trial, the investigator will ask all participants the following question: "Were you satisfied enough with the study medication that you would like to continue taking it for hot flashes?" | 12 weeks |
| Change in weight and body mass index (BMI) from baseline compared to study termination | 12 weeks |
| change in blood pressure from baseline compared to study termination. | 12 weeks |
| Adherence to study medication based on pill counts | 12 weeks |