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

NCT00299364 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2006-03-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Black Cohosh (iCR) or tibolone

Sponsors & Collaborators

  • Schaper & Bruemmer GmbH & Co KG

    lead INDUSTRY

Principal Investigators

  • Wenpai Bai, MD PhD · The First Hospital of Peking University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Completion
2005-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00299364 on ClinicalTrials.gov