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

Schaper & BrÃ¼mmer

Status and phase

Completed

Phase 3

Conditions

Menopause

Treatments

Drug: Black Cohosh (iCR) or tibolone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00299364

SB-FEM0401

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

40 to 60 years old

Volunteers

No Healthy Volunteers

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