Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety

Completed · Phase 4 · Has a placebo group

Conditions studied: Generalized Anxiety Disorder, Menopause

In brief

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 effect compared to placebo. 2) Black cohosh will have a comparable safety profile to that of placebo.

Key facts

Study ID

NCT00120458

Run by

University of Pennsylvania

People needed

50

Starts

2005-07-01

Expected to finish

2008-12-01

Last updated by the study team

2010-03-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Currently experiencing menopause or postmenopausal
• Have symptoms of menopause-related anxiety

You may not qualify if…

• 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

Where it is running

• Depression Research Unit, University of Pennsylvania School of Medicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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