Menopause
Conditions
Keywords
Climacteric symptoms, Black Cohosh, Efficacy, Safety
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 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
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.
Interventions
DRUGBlack Cohosh (iCR) or tibolone
Sponsors
Schaper & Bruemmer GmbH & Co KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| subject's global assessment of efficacy | — |
| Kupperman Menopause Index (KMI) | — |
| KMI based responder rate | — |
| CGI 1 | — |
| CGI 2 | — |
| CGI 3.1 | — |
| assessments of adverse events | — |
| physical examinations | — |
| global assessment of tolerability | — |
| laboratory tests | — |
Countries
China
Outcome results
None listed