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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00299364
Recruitment Status : Completed
First Posted : March 6, 2006
Last Update Posted : March 6, 2006
Sponsor:
Information provided by:

Study Description
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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : September 2004
Estimated Study Completion Date : May 2005

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Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Kupperman Menopause Index (KMI)
  2. KMI based responder rate
  3. CGI 1
  4. CGI 2
  5. CGI 3.1
  6. subject's global assessment of efficacy
  7. assessments of adverse events
  8. physical examinations
  9. global assessment of tolerability
  10. laboratory tests

Eligibility Criteria

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes 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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299364


Locations
China
Department of Gynecology, First Hospital of Peking University
Beijing, China
Department of Gynecology, General Hospital of PLA
Beijing, China
Department of Gynecology, Third 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

ClinicalTrials.gov Identifier: NCT00299364     History of Changes
Other Study ID Numbers: SB-FEM0401
First Posted: March 6, 2006    Key Record Dates
Last Update Posted: March 6, 2006
Last Verified: March 2006

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
Antihypertensive Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Modulators
Anabolic Agents
Hormones