- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01957306
Safety and Efficacy of Dr. Tagliaferri's Menopause Formula
June 12, 2014 updated by: Herba Buena, Inc
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Diego, California, United States, 92108
- Medical Center for Clinical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 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.
- 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.
- 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.
- Currently taking morphine or other opiates on a chronic basis.
- Any laboratory findings out of normal range deemed clinically significant.
- BMI >35 kg/m2
- History of substance abuse within the past year.
- Use of another investigational agent within 1 month prior to screening.
- History of severe food or medicine allergies resulting in anaphylactic shock, requiring hospitalization, or requiring use of epinephrine.
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dr. Tagliaferri's Menoapause Formula
Administered as 2 grams PO BID.
|
Administered as 2 grams PO BID
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in frequency of moderate to severe hot flushes from baseline to 12 weeks.
Time Frame: 12 weeks
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12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events assessment
Time Frame: 12 weeks
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12 weeks
|
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Change in the frequency of hot flushes that awake participants during sleep
Time Frame: 12 weeks
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12 weeks
|
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Change in frequency of moderate to severe hot flushes from baseline to week 4
Time Frame: 4 weeks
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4 weeks
|
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Change in severity of moderate to severe hot flushes from baseline to week 4
Time Frame: 4 weeks
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4 weeks
|
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Change in severity of moderate to severe hot flushes from baseline to week 12
Time Frame: 12 weeks
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12 weeks
|
|
The clinical meaningfulness of the reduction in hot flashes
Time Frame: 12 weeks
|
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?"
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12 weeks
|
Change in weight and body mass index (BMI) from baseline compared to study termination
Time Frame: 12 weeks
|
12 weeks
|
|
change in blood pressure from baseline compared to study termination.
Time Frame: 12 weeks
|
12 weeks
|
|
Adherence to study medication based on pill counts
Time Frame: 12 weeks
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12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: William Koltun, MD, Medical Center for Clinical Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
September 30, 2013
First Submitted That Met QC Criteria
October 7, 2013
First Posted (Estimate)
October 8, 2013
Study Record Updates
Last Update Posted (Estimate)
June 13, 2014
Last Update Submitted That Met QC Criteria
June 12, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HB-101-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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