drugset / Trial / NCT00299364
Comparison of the Efficacy and Tolerability of Black Cohosh Vs Tibolone in Patients With Menopausal Symptoms
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Black Cohosh | Traditional medicine (herbal / TCM) | 40 mg | Oral |
| Subject | Tibolone | Other / unclassified | 2.5 mg | Oral |
Indications
No indication recorded.