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Effects of Black Cohosh on Menopausal Hot Flashes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00010712
First Posted: February 5, 2001
Last Update Posted: August 18, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
February 2, 2001
February 5, 2001
August 18, 2006
September 1999
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Complete list of historical versions of study NCT00010712 on ClinicalTrials.gov Archive Site
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Effects of Black Cohosh on Menopausal Hot Flashes
Effects of Black Cohosh on Menopausal Hot Flashes
This study will assess whether treatment with black cohosh is effective in reducing the frequency and intensity of menopausal hot flashes. In addition, this study will determine whether or not black cohosh reduces the frequency of other menopausal symptoms and improves quality of life.

Most American women will spend the last third of their lives post-menopause. During this time, chronically low levels of steroidal estrogens may lead to a number of short and long-term medical sequelae such as hot flashes, vaginal dryness, heart disease, and osteoporosis. While some physicians believe that demonstrated beneficial effects of estrogen, particularly on the cardiovascular and skeletal systems, warrant the taking of hormone therapy from menopause on, many women choose not to take estrogen replacement therapy (ERT) and are increasingly exploring alternative approaches to ERT.

For centuries, black cohosh (Cimicifuga racemosa) has been used worldwide for women's health. Despite its long-standing use, studies of black cohosh have yielded conflicting data, in part because of lack in study design rigor and the short duration of studies to date. The primary aim of this study is to correct past shortcomings in study design to determine whether treatment with black cohosh is effective in treating menopausal symptoms.

Participants in this study will be given black cohosh for a 12-month period. Potential mechanisms of action of black cohosh will be examined by quantifying the levels of sex hormones, including estradiol, estrone, FSH, and LH. Because black cohosh may act as an estrogenic agent, the effect on endometrium will be evaluated by sonogram and by monitoring the incidence of adverse events and compliance with the study.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
  • Postmenopause
  • Hot Flashes
  • Osteoporosis, Postmenopausal
Drug: Black Cohosh
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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July 2005
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Inclusion Criteria:

  • Resident of the New York Metro Area
  • Postmenopausal
  • Weight within 90% to 120% of ideal body weight
Sexes Eligible for Study: Female
45 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00010712
P50AT000090-01P3( U.S. NIH Grant/Contract )
P50AT000090-01 ( U.S. NIH Grant/Contract )
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National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Dr. Fredi Kronenberg Columbia University
National Center for Complementary and Integrative Health (NCCIH)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP