Hot FlashesPhase 2NCT01957306
Safety and Efficacy of Dr. Tagliaferri's Menopause Formula
A Phase 2 study testing Dr. Tagliaferri's Menopause Formula in people with Hot Flashes, run by Herba Buena, Inc at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Dr. Tagliaferri's Menopause Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Center for Clinical Research
San Diego, California, 92108
About this study
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
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
- Being tested
- Dr. Tagliaferri's Menopause Formula
- Keywords
- hot flashes, night sweats
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dr. Tagliaferri's Menopause FormulaDietary supplement
Administered as 2 grams PO BID
| Study group | Role | What they receive |
|---|---|---|
| Dr. Tagliaferri's Menoapause Formula | Experimental | Administered as 2 grams PO BID. Receives: Dietary Supplement: Dr. Tagliaferri's Menopause Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of moderate to severe hot flushes from baseline to 12 weeks.
Measured: 12 weeks
Secondary outcomes (9)
Adverse events assessment
Measured: 12 weeks
Change in the frequency of hot flushes that awake participants during sleep
Measured: 12 weeks
Change in frequency of moderate to severe hot flushes from baseline to week 4
Measured: 4 weeks
Change in severity of moderate to severe hot flushes from baseline to week 4
Measured: 4 weeks
Change in severity of moderate to severe hot flushes from baseline to week 12
Measured: 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?"
Measured: 12 weeks
Change in weight and body mass index (BMI) from baseline compared to study termination
Measured: 12 weeks
change in blood pressure from baseline compared to study termination.
Measured: 12 weeks
Adherence to study medication based on pill counts
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herba Buena, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Koltun, MD, Principal investigator, Medical Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957306
- Sponsor's protocol ID
- HB-101-001
- Status last verified
- Jun 2014
- First submitted
- 30 Sep 2013
- Last updated
- 13 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01957306
- Acronym / sponsor ID
- HB-101-001
- Conditions
- Hot Flashes
- Keywords
- hot flashes, night sweats
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Herba Buena, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dr. Tagliaferri's Menoapause Formula | Experimental | Dietary Supplement: Dr. Tagliaferri's Menopause FormulaAdministered as 2 grams PO BID. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dr. Tagliaferri's Menopause FormulaAdministered as 2 grams PO BID | Dietary supplement | Dr. Tagliaferri's Menoapause Formula |
Primary outcome
Change in frequency of moderate to severe hot flushes from baseline to 12 weeks.
Time frame: 12 weeks
9 secondary outcomes
Adverse events assessment
Time frame: 12 weeks
Change in the frequency of hot flushes that awake participants during sleep
Time frame: 12 weeks
Change in frequency of moderate to severe hot flushes from baseline to week 4
Time frame: 4 weeks
Change in severity of moderate to severe hot flushes from baseline to week 4
Time frame: 4 weeks
Change in severity of moderate to severe hot flushes from baseline to week 12
Time frame: 12 weeks
The clinical meaningfulness of the reduction in hot flashes
Time frame: 12 weeks
Change in weight and body mass index (BMI) from baseline compared to study termination
Time frame: 12 weeks
change in blood pressure from baseline compared to study termination.
Time frame: 12 weeks
Adherence to study medication based on pill counts
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Koltun, MD principal investigator
Medical Center for Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dr. Tagliaferri's Menopause Formula in people with Hot Flashes, run by Herba Buena, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of moderate to severe hot flushes from baseline to 12 weeks. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2014.