Hot FlashesPhase 2NCT00119418
TU 025 Keishi Bukuryo Gan for Post-menopausal Hot Flash Management
A Phase 2 study testing TU 025 Keishi Bukuryo Gan in people with Hot Flashes and Menopause, run by Plotnikoff, Gregory A., M.D. at 1 site in United States.
Trial summary
This study tests to see if TU 025 Keishi Bukuryo Gan reduces the frequency and severity of hot flashes in post-menopausal American women. This study will also estimate the best dose amount and determine the common short-term side effects and risks. Read more about this study
- Who is it for?
- Ages 45 to 58 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes, Menopause
- What is being tested?
- TU 025 Keishi Bukuryo Gan
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Feb 2006
- 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 45 to 58 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Post-menopausal women aged 45-58 with an adequate hot flash frequency severity score. Post-menopause is defined as amenorrhea for at least 12 months, or post-hysterectomy for more than one year with follicle-stimulating hormone levels greater than or equal to 40 mIU/mL and estradiol (E2) levels of less than or equal to 20 pg/mL, or greater than two months post oophorectomy.
- All subjects must be up to date with both pap and mammogram screening by the US Preventative Services Taskforce Guidelines for the length of the trial.
- All subjects on any prescription medication need the approval of their prescribing physician for participation in the trial.
Who cannot join
- Concurrent hot flash therapies (prescription medications including hormones, antidepressants, SERMs, gabapentin or over the counter supplements)
- Moderately severe disease state(s) or diseases that affect absorption/metabolism, or diseases that mimic menopausal hot flashes.
- Inability to swallow vitamin size pills
- Beck depression inventory score greater than 11
- Greater than 10 cigarettes per day
- Abnormal liver function
Show all 11Show fewer
- Treated or untreated hypertension greater than 160/90.
- BMI greater than 36
- Inability to give consent or commit to the length of the trial
- Known hypersensitivity to ingredients
- Physician judgment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota General Clinical Research Center
Minneapolis, Minnesota, 55455
About this study
Official title: TU 025 Keishi Bukuryo Gan for Post-Menopausal Hot Flash Management
This study tests to see if TU 025 Keishi Bukuryo Gan reduces the frequency and severity of hot flashes in post-menopausal American women. This study will also estimate the best dose amount and determine the common short-term side effects and risks.
Read the detailed description
Menopause is a natural transition in a woman's hormonal state associated with the cessation of ovulation and menstruation. For approximately 80% of peri-menopausal women, menopause may be defined by the experience of uncomfortable symptoms such as hot flashes, night sweats, dyspareunia, urinary frequency, sleep disturbance, fatigue, depression and anxiety.
Hot flashes are the most common complaint of perimenopausal and postmenopausal Western women. Approximately 10-20% of postmenopausal women find such symptoms nearly intolerable. Nearly one-third of postmenopausal women experience disruptive hot flashes for 5 years after natural menopause and approximately 20% experience hot flashes for 15 years.
Menopause has been understood as an estrogen deficiency state from which women are placed at great risk for osteoporosis, colon cancer and heart disease. For symptom management, as well as for disease prevention, the medical response for 20 years has been hormone replacement therapy (HRT). In recent years, as many as 38% of US women between ages 50 and 74 years were using HRT.
For menopause hormone therapy, in 2005, counseling patients from an evidence-based perspective means informing patients of the significantly increased risk of dementia, breast cancer,endometrial cancer,venous thromboembolism and gallbladder disease. Additionally, physicians must also state that hormone therapy increases the risk of cardiovascular events (heart attack or strokes) in women with or without pre-existing heart disease. Furthermore, well-done studies demonstrate that hormone therapy does not enhance health-related quality of life.
For this reason, there is great interest in non-hormonal alternatives for menopausal hot flash management. The current standard of care, based on controlled clinical trials in women with breast cancer, is the use of SSRI anti-depressants such as venlafaxine. However, many women seek other options.
In Japan, TJ25 Keishi Bukuryo Gan is a leading non-hormonal prescription agent for management of menopausal hot flashes. However, no clinical data exists on its effectiveness in American women.
This is a pilot phase II clinical study to estimate the effectiveness of TU-25 Keishi Bukuryo Gan for reduction of both the severity and the frequency of hot flashes in healthy postmenopausal American women. This study will also estimate the best dose and determine the common short-term side effects and risks.
- Conditions
- Hot Flashes, Menopause
- Being tested
- TU 025 Keishi Bukuryo Gan
- Keywords
- hot flash, menopause, herbal medicine, kampo, alternative medicine
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TU 025 Keishi Bukuryo GanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency and severity of hot flashes by Mayo Hot Flash Diary
Secondary outcomes (6)
sleep quality by the Pittsburgh Questionnaire
bodyweight/BMI by standard measurements
quality of menopausal life by Greene Climacteric Scale
lipid profile by laboratory test
liver function profile by laboratory test
hormone profile by laboratory test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2005 (estimated)
- Study startNov 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Plotnikoff, Gregory A., M.D.
- Collaborators
- Tsumura and Company, Tokyo, Japan, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119418
- Sponsor's protocol ID
- 0402M56292
- Other IDs
- M01-RR00400 NIH, M01RR000400
- Status last verified
- Jul 2005
- First submitted
- 4 Jul 2005
- Last updated
- 26 Oct 2010
- Results posted
- No
Publications
Plotnikoff GA, Watanabe K, Torkelson C, La Valleur J, Radosevich DM. The TU-025 keishibukuryogan clinical trial for hot flash management in postmenopausal women: results and lessons for future research. Menopause. 2011 Aug;18(8):886-92. doi: 10.1097/gme.0b013e31821643d9.
PubMed 21738077
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TU 025 Keishi Bukuryo Gan for Post-Menopausal Hot Flash Management
- ClinicalTrials.gov ID
- NCT00119418
- Acronym / sponsor ID
- 0402M56292
- Conditions
- Hot Flashes, Menopause
- Keywords
- hot flash, menopause, herbal medicine, kampo, alternative medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Plotnikoff, Gregory A., M.D.
- Collaborators
- Tsumura and Company, Tokyo, Japan, University of Minnesota
- Study start
- Nov 2004
- Study completion
- Feb 2006
- First posted
- 13 Jul 2005 (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.
This study tests to see if TU 025 Keishi Bukuryo Gan reduces the frequency and severity of hot flashes in post-menopausal American women. This study will also estimate the best dose amount and determine the common short-term side effects and risks.
Detailed description
Menopause is a natural transition in a woman's hormonal state associated with the cessation of ovulation and menstruation. For approximately 80% of peri-menopausal women, menopause may be defined by the experience of uncomfortable symptoms such as hot flashes, night sweats, dyspareunia, urinary frequency, sleep disturbance, fatigue, depression and anxiety.
Hot flashes are the most common complaint of perimenopausal and postmenopausal Western women. Approximately 10-20% of postmenopausal women find such symptoms nearly intolerable. Nearly one-third of postmenopausal women experience disruptive hot flashes for 5 years after natural menopause and approximately 20% experience hot flashes for 15 years.
Menopause has been understood as an estrogen deficiency state from which women are placed at great risk for osteoporosis, colon cancer and heart disease. For symptom management, as well as for disease prevention, the medical response for 20 years has been hormone replacement therapy (HRT). In recent years, as many as 38% of US women between ages 50 and 74 years were using HRT.
For menopause hormone therapy, in 2005, counseling patients from an evidence-based perspective means informing patients of the significantly increased risk of dementia, breast cancer,endometrial cancer,venous thromboembolism and gallbladder disease. Additionally, physicians must also state that hormone therapy increases the risk of cardiovascular events (heart attack or strokes) in women with or without pre-existing heart disease. Furthermore, well-done studies demonstrate that hormone therapy does not enhance health-related quality of life.
For this reason, there is great interest in non-hormonal alternatives for menopausal hot flash management. The current standard of care, based on controlled clinical trials in women with breast cancer, is the use of SSRI anti-depressants such as venlafaxine. However, many women seek other options.
In Japan, TJ25 Keishi Bukuryo Gan is a leading non-hormonal prescription agent for management of menopausal hot flashes. However, no clinical data exists on its effectiveness in American women.
This is a pilot phase II clinical study to estimate the effectiveness of TU-25 Keishi Bukuryo Gan for reduction of both the severity and the frequency of hot flashes in healthy postmenopausal American women. This study will also estimate the best dose and determine the common short-term side effects and risks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 58 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Post-menopausal women aged 45-58 with an adequate hot flash frequency severity score. Post-menopause is defined as amenorrhea for at least 12 months, or post-hysterectomy for more than one year with follicle-stimulating hormone levels greater than or equal to 40 mIU/mL and estradiol (E2) levels of less than or equal to 20 pg/mL, or greater than two months post oophorectomy.
- All subjects must be up to date with both pap and mammogram screening by the US Preventative Services Taskforce Guidelines for the length of the trial.
- All subjects on any prescription medication need the approval of their prescribing physician for participation in the trial.
Key exclusion criteria (11 listed)
- Concurrent hot flash therapies (prescription medications including hormones, antidepressants, SERMs, gabapentin or over the counter supplements)
- Moderately severe disease state(s) or diseases that affect absorption/metabolism, or diseases that mimic menopausal hot flashes.
- Inability to swallow vitamin size pills
- Beck depression inventory score greater than 11
- Greater than 10 cigarettes per day
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 |
|---|---|---|
| TU 025 Keishi Bukuryo Gan | Drug | – |
Primary outcome
frequency and severity of hot flashes by Mayo Hot Flash Diary
6 secondary outcomes
sleep quality by the Pittsburgh Questionnaire
bodyweight/BMI by standard measurements
quality of menopausal life by Greene Climacteric Scale
lipid profile by laboratory test
liver function profile by laboratory test
hormone profile by laboratory test
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 26 Oct 2010.
- Derived from this study: PubMed 21738077Plotnikoff GA, Watanabe K, Torkelson C, La Valleur J, Radosevich DM. The TU-025 keishibukuryogan clinical trial for hot flash management in postmenopausal women: results and lessons for future research. Menopause. 2011 Aug;18(8):886-92. doi: 10.1097/gme.0b013e31821643d9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 TU 025 Keishi Bukuryo Gan in people with Hot Flashes and Menopause, run by Plotnikoff, Gregory A., M.D. 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 3 inclusion and 11 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 26 Oct 2010. 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?
frequency and severity of hot flashes by Mayo Hot Flash Diary. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00119418, which also lists 1 linked publication.
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 26 Oct 2010.