Black Cohosh Extract in Postmenopausal Breast Health

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Menopause; Hot Flashes

Treatments: Drug: Black Cohosh Extract (BCE)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00064831

R21AT001102-01

SauterE

Details and patient eligibility

About

The purpose of the study is to determine if black cohosh extract (BCE) administration in symptomatic postmenopausal women results in estrogenic stimulation of the breast, as determined by estradiol, pS2, FSH, LH, and PSA levels in nipple aspirate fluid.

Full description

As in Brief Summary

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Postmenopausal females
• 20 months since any breastfeeding
• Active postmenopausal symptoms, i.e., hot flashes
• At least 6 months since last menstrual period or have had a hysterectomy with both ovaries removed
• Able to make 4 visits during the trial to the study clinic in Columbia, Missouri

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)