A Study of the Pharmacokinetics of Black Cohosh

National Institutes of Health (NIH)

Status and phase: Terminated; Phase 1

Conditions: Hot Flashes

Treatments: Drug: Black cohosh

Study type: Interventional

Funder types: NIH

Identifiers

NCT00068185

K08AT001315-01A1

Details and patient eligibility

About

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.

Full description

As per Brief Summary

Enrollment: 12 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)