TU 025 Keishi Bukuryo Gan for Post-menopausal Hot Flash Management

Completed · Phase 2

Conditions studied: Hot Flashes, Menopause

In brief

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.

Key facts

Study ID

NCT00119418

Run by

Plotnikoff, Gregory A., M.D.

People needed

180

Starts

2004-11-01

Expected to finish

2006-02-01

Last updated by the study team

2010-10-26

Who can join

Age: 45 and older, up to 58. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Minnesota General Clinical Research Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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