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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 drug/day (n=122) or tibolone 2,5 mg/day (n=122) 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.

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

Conditions
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Menopause

Intervention / Treatment
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* Drug: Black Cohosh (iCR) or tibolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between 40 years and 60 years of age spontaneous amenorrheic interval at least 5 months since the last regular menstruation for those patients with amenorrheic interval less than 12 months, the baseline level of E2 should not exceed 30 pg/ml Kupperman Menopause Index at least 15 written informed consent good general health Exclusion Criteria: HRT in the last 4 weeks before study entry treatment with non-hormonal climacteric drug (including TCM and nutritional supplement) and use of food which can interfere with menopausal symptoms during the last week before study entry or during the wash-out period before the first KMI evaluation treatment with drugs (including phytotherapeutics) of the ATC groups N03, N05 or N06 during the last four weeks before study entry or during the wash-out period before the first KMI evaluation BMI > 28 kg/m2 thickness of uterine intima equal or more than 5 mm (only in patients with amenorrhea of 12 months or longer) or more than 15 mm (only in patients with amenorrhea of less than 12 months) irregular gynecological bleeding in the last 4 weeks before start of study medication without an endometrial carcinoma ruled out cervical smear (ASCUS) expressed anything of as follows: intraepithelial pathologic change (CIN1, CIN2, CIN3, carcinoma in situ), squamous carcinoma hysterectomy or supracervical hysterectomy more than eight years amenorrhea contraindication of tibolone cancer severe disease (e.g. ...) which could mask the climacteric complaints or the treatment of which could interfere with the study objectives. For example, ... diseases which could influence the baseline measurement of the KMI drug abuser, alcohol addicts, etc. participation in another clinical trial of phase I, II during the last 180 days or of phase III, IV during the last 90 days before study entry, or simultaneous participation in another clinical trial other circumstances that make the investigator expect an incomplete study participation of the patient

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Black Cohosh (iCR) or tibolone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Benefit-risk-balance = combination of the Mann-Whitney values (MWV) of the KMI and the frequency of adverse events at end of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kupperman Menopause Index (KMI) |  |  | 
| KMI based responder rate |  |  | 
| CGI 1 |  |  | 
| CGI 2 |  |  | 
| CGI 3.1 |  |  | 
| subject's global assessment of efficacy |  |  | 
| assessments of adverse events |  |  | 
| physical examinations |  |  | 
| global assessment of tolerability |  |  | 
| laboratory tests |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Climacteric symptoms, Black Cohosh, Efficacy, Safety