Multi-Center, Randomized, Double-Blind, Parallel-Controlled Study on the Efficacy and Tolerability of Black Cohosh Vs Tibolone in Patients With Menopausal Symptoms

NCT00299364 Phase 3 COMPLETED

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.

Details

Lead sponsor	Schaper & Bruemmer GmbH & Co KG
Phase	Phase 3
Status	COMPLETED
Enrolment	240
Start date	2004-09
Completion	2005-05

Conditions

• Menopause

Interventions

• Black Cohosh (iCR) or tibolone

Primary outcomes

• Benefit-risk-balance = combination of the Mann-Whitney values (MWV) of the KMI and the frequency of adverse events at end of treatment

Countries

China