Safety and Efficacy of Dr. Tagliaferri's Menopause Formula

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Herba Buena, Inc
ClinicalTrials.gov Identifier:
NCT01957306
First received: September 30, 2013
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Hot Flashes
Dietary Supplement: Dr. Tagliaferri's Menopause Formula
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Herba Buena, Inc:

Primary Outcome Measures:
  • Change in frequency of moderate to severe hot flushes from baseline to 12 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change in the frequency of hot flushes that awake participants during sleep [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in frequency of moderate to severe hot flushes from baseline to week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in severity of moderate to severe hot flushes from baseline to week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in severity of moderate to severe hot flushes from baseline to week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The clinical meaningfulness of the reduction in hot flashes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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?"

  • Change in weight and body mass index (BMI) from baseline compared to study termination [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • change in blood pressure from baseline compared to study termination. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Adherence to study medication based on pill counts [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dr. Tagliaferri's Menoapause Formula
Administered as 2 grams PO BID.
Dietary Supplement: Dr. Tagliaferri's Menopause Formula
Administered as 2 grams PO BID

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Provide written informed consent.
  2. Postmenopausal women aged 40-65 years.
  3. Postmenopausal as defined by one of the following criteria:

    1. 12 months of spontaneous amenorrhea;
    2. 6 months of spontaneous amenorrhea with serum FSH >30 mIU/ml;
    3. 6 weeks of surgical amenorrhea following bilateral oophorectomy with or without hysterectomy; or
    4. hysterectomy alone with serum FSH >30 mIU/ml.
  4. 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.
  5. 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.
  6. Currently receive medical care from a health care provider.

Exclusion Criteria:

  1. 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).
  2. Known carrier of BRCA1 or BRCA2.
  3. Within 12 months of screening, abnormal mammogram or breast examination that is suggestive of cancer, or refused mammogram or breast exam.
  4. Within 12 months of screening, abnormal Pap smear or pelvic examination that is suggestive of cancer, or refused Pap smear or pelvic exam.
  5. Transvaginal Ultrasound (TVUS) double-wall endometrium of >8mm on TVUS.
  6. Participants with polyps or other abnormal uterine masses (with the exception of fibroids) on TVUS.
  7. Unexplained uterine bleeding within six months prior to screening.
  8. Clinical evidence of active ischemic cardiovascular disease or history of cardiovascular disease.
  9. Uncontrolled hypertension (≥160/100 at baseline or within 4 weeks prior to screening) or a history of transient ischemic attack or cerebrovascular accidents.
  10. History of deep vein thrombosis or pulmonary embolism.
  11. Active liver disease or a history of impaired hepatic function.
  12. History of chronic hepatitis B or C, hepatitis within the past 3 months, or HIV infection.
  13. History of severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS), uncontrolled inflammatory bowel disease (IBD), or unexplained weight loss.
  14. Active gallbladder disease.
  15. 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.
  16. Use of herbal or dietary supplements purported to treat hot flushes or herbal/dietary supplements with known estrogenic or progestogenic activity within 2 weeks of screening.
  17. Use of herbal or dietary supplements within 2 weeks prior to screening, unless the participant agrees not to change the frequency or dose of the herbal supplement for the entire duration of study treatment.
  18. Currently taking morphine or other opiates on a chronic basis.
  19. Any laboratory findings out of normal range deemed clinically significant.
  20. BMI >35 kg/m2
  21. History of substance abuse within the past year.
  22. Use of another investigational agent within 1 month prior to screening.
  23. History of severe food or medicine allergies resulting in anaphylactic shock, requiring hospitalization, or requiring use of epinephrine.
  24. Any concern or medical, emotional or psychiatric condition that, in the investigator's opinion, would preclude the participant from providing informed consent, completing questionnaires, adhering to the protocol or completing the trial (e.g., severe illness, plans to move, substance abuse, significant psychiatric problems, or dementia).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01957306

Locations
United States, California
Medical Center for Clinical Research
San Diego, California, United States, 92108
Sponsors and Collaborators
Herba Buena, Inc
Investigators
Principal Investigator: William Koltun, MD Medical Center for Clinical Research
  More Information

Additional Information:
No publications provided

Responsible Party: Herba Buena, Inc
ClinicalTrials.gov Identifier: NCT01957306     History of Changes
Other Study ID Numbers: HB-101-001
Study First Received: September 30, 2013
Last Updated: June 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Herba Buena, Inc:
hot flashes, night sweats

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 10, 2014