Comparison of the Efficacy and Tolerability of Black Cohosh Vs Tibolone in Patients With Menopausal Symptoms - Full Text View

Purpose

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.

Condition	Intervention	Phase
Menopause	Drug: Black Cohosh (iCR) or tibolone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Menopause

U.S. FDA Resources

Further study details as provided by Schaper & Bruemmer GmbH & Co KG:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	240
Study Start Date:	September 2004
Estimated Study Completion Date:	May 2005

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

Ages Eligible for Study:	40 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299364

Locations

China
Department of Gynecology, General Hospital of PLA
Beijing, China
Department of Gynecology, Third Hospital of Peking University
Beijing, China
Department of Gynecology, First Hospital of Peking University
Beijing, China
Department of Gynecology, West China Second Hospital of Sichuan University
Chengdu, China
Department of Gynecology, Jiangsu Province People's Hospital
Nanjing, China

Sponsors and Collaborators

Schaper & Bruemmer GmbH & Co KG

Investigators

Principal Investigator:

Wenpai Bai, MD PhD

The First Hospital of Peking University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00299364 History of Changes
Other Study ID Numbers:	SB-FEM0401
Study First Received:	March 1, 2006
Last Updated:	March 2, 2006
Health Authority:	China: Food and Drug Administration

Keywords provided by Schaper & Bruemmer GmbH & Co KG:

Climacteric symptoms
Black Cohosh
Efficacy
Safety

Additional relevant MeSH terms:

Tibolone
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antihypertensive Agents

Cardiovascular Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Modulators
Anabolic Agents
Hormones

ClinicalTrials.gov processed this record on May 22, 2013