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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00119418
• Other study ID #: 0402M56292
• Secondary ID: M01-RR00400 NIH
• Status: Completed
• Phase: Phase 2
• First received: July 4, 2005
• Last updated: October 25, 2010
• Start date: November 2004
• Est. completion date: February 2006

Study information

• Verified date: July 2005
• Source: Plotnikoff, Gregory A., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 58 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hot Flashes
• Menopause

Intervention

Drug:
• TU 025 Keishi Bukuryo Gan

Locations

Country	Name	City	State
United States	University of Minnesota General Clinical Research Center	Minneapolis	Minnesota

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency and severity of hot flashes by Mayo Hot Flash Diary
Secondary	sleep quality by the Pittsburgh Questionnaire
Secondary	bodyweight/BMI by standard measurements
Secondary	quality of menopausal life by Greene Climacteric Scale
Secondary	lipid profile by laboratory test
Secondary	liver function profile by laboratory test
Secondary	hormone profile by laboratory test