Status:
COMPLETED
TU 025 Keishi Bukuryo Gan for Post-menopausal Hot Flash Management
Lead Sponsor:
Plotnikoff, Gregory A., M.D.
Collaborating Sponsors:
Tsumura and Company, Tokyo, Japan
University of Minnesota
Conditions:
Hot Flashes
Menopause
Eligibility:
FEMALE
45-58 years
Phase:
PHASE2
Brief 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 determi...
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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2006
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00119418
Start Date
November 1 2004
End Date
February 1 2006
Last Update
October 26 2010
Active Locations (1)
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1
University of Minnesota General Clinical Research Center
Minneapolis, Minnesota, United States, 55455