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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||TU 025 Keishi Bukuryo Gan for Post-Menopausal Hot Flash Management|
- frequency and severity of hot flashes by Mayo Hot Flash Diary
- 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
|Study Start Date:||November 2004|
|Estimated Study Completion Date:||February 2006|
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.
|United States, Minnesota|
|University of Minnesota General Clinical Research Center|
|Minneapolis, Minnesota, United States, 55455|