Status:
COMPLETED
Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Conditions:
Generalized Anxiety Disorder
Menopause
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
This study will determine the effectiveness of the herb black cohosh for treating menopause-related anxiety symptoms in women. Study hypotheses: 1) Black cohosh will have a superior anti-anxiety effe...
Detailed Description
During menopause, up to 90% of women will experience symptoms of anxiety, such as nervousness, irritability, fatigue, muscle aches, depression, and low libido. Concern over the safety and effectivenes...
Eligibility Criteria
Inclusion
- Currently experiencing menopause or postmenopausal
- Have symptoms of menopause-related anxiety
Exclusion
- Any form of generalized anxiety disorder (GAD) unrelated to menopause
- Onset of GAD at least 3 years prior to menopause or at least 5 years after menstruation has stopped
- Alcohol or drug dependence within 3 months prior to study entry
- Allergy to black cohosh
- History of hormone replacement therapy
- Current use of vaginal estrogen cream or phytoestrogens
- Current use of tranquilizers, antidepressants, or antianxiety therapies
- Abnormal uterine bleeding
- History of estrogen-dependent cancer
- History of endometrial hyperplasia (abnormal increase in cells) or endometrial cancer
- Rapidly growing uterine fibroids
- Abnormal finding upon gynecological examination that would interfere with the study
- Abnormal breast examination or mammogram
- Any unstable medical condition
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00120458
Start Date
July 1 2005
End Date
December 1 2008
Last Update
March 2 2010
Active Locations (1)
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1
Depression Research Unit, University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104-3309