A Study of MF101 in Postmenopausal Women (HERBA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Bionovo.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Bionovo
ClinicalTrials.gov Identifier:
NCT00906308
First received: May 19, 2009
Last updated: February 6, 2012
Last verified: February 2012

May 19, 2009
February 6, 2012
October 2011
February 2013   (final data collection date for primary outcome measure)
Determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Safety will be measured through clinically significant findings in physical examinations, laboratory parameters, endometrial changes, abnormal uterine bleeding and any other adverse events. Efficacy will be measured by the mean change in frequency of moderate to severe hot flushes from baseline to treatment week 12.
  • To evaluate the safety of Menerba. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change in frequency and severity of moderate to severe hot flashes. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00906308 on ClinicalTrials.gov Archive Site
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A Study of MF101 in Postmenopausal Women
A Phase 3, Double-blind, Placebo-Controlled, Randomized Clinical Trial, Assessing Safety and Efficacy of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women

This phase 3a study is designed to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women.

Menopausal women often experience debilitating menopausal vasomotor symptoms and associated insomnia. Until recently, vasomotor symptoms were often treated with estrogens, which are very effective; however, randomized clinical trials have shown that postmenopausal combination hormone therapy increases the risks for stroke, cardiovascular events, and breast cancer. New, more effective, and safer treatments for menopausal vasomotor symptoms are therefore needed.

MF101, a botanical extract, is a non-hormonal investigational treatment being tested in a randomized, double-blind, placebo-controlled phase 3a clinical trial to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women. Approximately 1200 healthy post-menopausal women, aged 40-65, with moderate to severe hot flushes will be enrolled to determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo after 12 weeks of treatment.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hot Flushes
  • Vasomotor Symptoms
  • Drug: MF101 5 g/day
    PO (orally) 5 g/day (administered twice a day, BID) for up to 12 weeks
  • Drug: Placebo
    PO (orally) matched placebo (administered twice a day, BID) for up to 12 weeks
  • Drug: MF101 10 g/day
    PO (orally) 10 g/day (administered twice a day, BID) for up to 12 weeks
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: MF101 5 g/day
    Intervention: Drug: MF101 5 g/day
  • Experimental: MF101 10 g/day
    Intervention: Drug: MF101 10 g/day
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
Not Provided
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria (limited):

  • Confirmed postmenopausal women aged 40-65
  • Provide written informed consent

Exclusion Criteria (limited):

  • History of malignancy, with the exception of certain types of skin cancer or cervical cancer
  • Known carrier of BRCA1 or BRCA2
  • Abnormal mammogram or breast examination suggestive of cancer within 9 months of screening
  • Endometrial hyperplasia, polyps or abnormal uterine masses (with the exception of fibroids)
  • Clinical evidence of active ischemic heart disease, history of cardiovascular disease, uncontrolled hypertension, or a history of transient ischemic attacks or cerebrovascular accidents
  • History of deep vein thrombosis, pulmonary embolism, severe chronic diarrhea, chronic constipation, uncontrolled inflammatory bowel syndrome or disease (IBS or IBD), or unexplained weight loss
  • Active liver disease or gall bladder disease
  • History of chronic hepatitis B, hepatitis C, hepatitis within 3 months, or HIV infection
  • Use of prescription medications or herbal/dietary supplements for the treatment of hot flushes or those with known estrogenic/progestogenic activity within required wash-out timeframes
  • Use of selective receptor modulators (SERMs), aromatase inhibitors, gonadotropin-releasing hormone agonists, selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin or clonidine within required wash-out timeframes
  • Chronic use of morphine or other opiates
Female
40 Years to 65 Years
Yes
Contact: Jesse Langon, MPH 510-4204182
United States
 
NCT00906308
MF-101-004
Yes
Bionovo
Bionovo
Not Provided
Study Director: Mary Tagliaferri, M.D, L.Ac. Bionovo Inc.
Bionovo
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP