A Phase 2, Open Label Clinical Trial Assessing Safety and Efficacy of Dr. Tagliaferri's Menopause Formula for Hot Flushes and Menopausal Symptoms in Postmenopausal Women

Herba Buena, Inc1 site in 1 country30 target enrollmentNovember 2013

ConditionsHot Flashes

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hot Flashes
Sponsor: Herba Buena, Inc
Enrollment: 30
Locations: 1
Primary Endpoint: Change in frequency of moderate to severe hot flushes from baseline to 12 weeks.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

June 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Herba Buena, Inc

Responsible Party

Sponsor

Eligibility Criteria

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.
•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

•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 BRCA
•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.
•Uncontrolled hypertension (≥160/100 at baseline or within 4 weeks prior to screening) or a history of transient ischemic attack or cerebrovascular accidents.
•History of deep vein thrombosis or pulmonary embolism.

Outcomes

Primary Outcomes

Change in frequency of moderate to severe hot flushes from baseline to 12 weeks.

Time Frame: 12 weeks

Secondary Outcomes

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(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(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)