Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299364
Status:
COMPLETED
Last Update Posted:
2006-03-06
First Post:
2006-03-01
Brief Title:
Comparison of the Efficacy and Tolerability of Black Cohosh Vs Tibolone in Patients With Menopausal Symptoms
Sponsor:
Schaper Bruemmer GmbH Co KG
Organization:
Schaper Bruemmer GmbH Co KG
Study Overview
Official Title:
Multi-Center Randomized Double-Blind Parallel-Controlled Study on the Efficacy and Tolerability of Black Cohosh Vs Tibolone in Patients With Menopausal Symptoms
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 drugday n122 or tibolone 25 mgday n122 orally The primary endpoint is the benefit-risk balance at end of treatment
Detailed Description:
The benefit-risk-balance of the isopropanolic Cimicifuga racemosa extract iCR is compared with tibolone in menopausal symptoms treatment The randomized double-blind controlled 3-month study in 5 centres of 3 cities in China enrolled 244 menopausal patients aged 40 - 60 years and with a Kupperman Menopause Index KMI equal or more than 15 The participants were assigned to either iCR corresponding to 40 mg crude drugday n122 or tibolone 25 mgday n122 orally The primary endpoint is the combination of the Mann-Whitney values MWV of the KMI and the frequency of adverse events benefit-risk balance at end of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None