drugset / Trial / NCT00299364

Comparison of the Efficacy and Tolerability of Black Cohosh Vs Tibolone in Patients With Menopausal Symptoms

NCT00299364

Phase 3 Completed 240 enrolled Schaper & Bruemmer GmbH & Co KG
RandomizedParallel-groupDouble-blindTreatment

Summary

The benefit-risk-balance of the isopropanolic Cimicifuga racemosa extract (iCR) is compared with tibolone in menopausal symptoms treatment. Menopausal patients aged 40 - 60 years and with a Kupperman Menopause Index (KMI) equal or more than 15 participate and were assigned to either iCR corresponding to 40 mg crude drug/day (n=122) or tibolone 2,5 mg/day (n=122) orally. The primary endpoint is the benefit-risk balance at end of treatment.

Timeline

Start
2004-09
Primary completion
Completion
2005-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Black Cohosh Traditional medicine (herbal / TCM) 40 mg Oral
Subject Tibolone Other / unclassified 2.5 mg Oral

Indications

No indication recorded.