Clinical trial NCT00299364: Comparison of the Efficacy and Tolerability of Black Cohosh Vs Tibolone in Patients With Menopausal Symptoms
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menopause
Keywords: Climacteric symptoms
Black Cohosh
Efficacy
Safety
Lead sponsor: Schaper & Bruemmer GmbH & Co KG
Sponsor class: INDUSTRY
First posted: 2006-03-06
Enrollment: 240
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Benefit-risk-balance = combination of the Mann-Whitney values (MWV) of the KMI and the frequency of adverse events at end of treatment
Secondary outcomes:
measure: Kupperman Menopause Index (KMI)
measure: KMI based responder rate
measure: CGI 1
measure: CGI 2
measure: CGI 3.1
measure: subject's global assessment of efficacy
measure: assessments of adverse events
measure: physical examinations
measure: global assessment of tolerability
measure: laboratory tests
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Gynecology, First Hospital of Peking University
city: Beijing
country: China
facility: Department of Gynecology, General Hospital of PLA
city: Beijing
country: China
facility: Department of Gynecology, Third Hospital of Peking University
city: Chengdu
country: China
facility: Department of Gynecology, West China Second Hospital of Sichuan University
city: Nanjing
country: China
facility: Department of Gynecology, Jiangsu Province People's Hospital
Study officials:
affiliation: The First Hospital of Peking University
name: Wenpai Bai, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: