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

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Plotnikoff, Gregory A., M.D.
• Collaborators: Tsumura and Company, Tokyo, Japan; University of Minnesota; University of Minnesota - Clinical and Translational Science Institute

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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