A Study of the Pharmacokinetics of Black Cohosh

Phase 1

Terminated

• Conditions: Hot Flashes

• Registration Number: NCT00068185
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Brief Summary

Black cohosh is a natural supplement that has been used to treat and prevent menopausal symptoms. Remifemin is a standardized form of black cohosh. The purpose of this study is to determine the levels of components of black cohosh obtained in the blood of healthy women taking Remifemin.

Detailed Description

As per Brief Summary

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2003-09-09
• Study First Submitted QC: 2003-09-09
• Study First Posted: 2003-09-10
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-09
• Last Update Posted: 2009-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• No prior diagnosis of cancer other than non-melanoma skin cancer or carcinoma in-situ of the cervix
• No current prescription medication use
• Negative urine pregnancy test OR greater than age 50 with no menses for at least one year OR documented status post hysterectomy
• Competent to understand and sign informed consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States