Safety and Efficacy of Dr. Tagliaferri's Menopause Formula

NCT01957306 | Completed Phase 2

• 1 other identifier: HB-101-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hot Flashes

Keywords

hot flashes, night sweats

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (9)

• 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

Study Arms (1)

Dr. Tagliaferri's Menoapause Formula

EXPERIMENTAL

Administered as 2 grams PO BID.

Dietary Supplement: Dr. Tagliaferri's Menopause Formula

Interventions

Dr. Tagliaferri's Menopause Formula DIETARY_SUPPLEMENT

Administered as 2 grams PO BID

Dr. Tagliaferri's Menoapause Formula

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent.
• Postmenopausal women aged 40-65 years.
• Postmenopausal as defined by one of the following criteria:
• months of spontaneous amenorrhea;
• months of spontaneous amenorrhea with serum FSH \>30 mIU/ml;
• 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.

You may not qualify if:

• 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.
• 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.
• Active liver disease or a history of impaired hepatic function.
• History of chronic hepatitis B or C, hepatitis within the past 3 months, or HIV infection.
• History of severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS), uncontrolled inflammatory bowel disease (IBD), or unexplained weight loss.
• Active gallbladder disease.
• 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.

Sponsors & Collaborators

• Herba Buena, Inc: lead

Study Sites (1)

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William Koltun, MD

  Medical Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 8, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 13, 2014

Record last verified: 2014-06

Locations

US (1)