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
  Purpose

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.


Condition Intervention Phase
Hot Flushes
Vasomotor Symptoms
Drug: MF101 5 g/day
Drug: Placebo
Drug: MF101 10 g/day
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Bionovo:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 1200
Study Start Date: October 2011
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
PO (orally) matched placebo (administered twice a day, BID) for up to 12 weeks
Experimental: MF101 5 g/day Drug: MF101 5 g/day
PO (orally) 5 g/day (administered twice a day, BID) for up to 12 weeks
Experimental: MF101 10 g/day Drug: MF101 10 g/day
PO (orally) 10 g/day (administered twice a day, BID) for up to 12 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906308

Contacts
Contact: Jesse Langon, MPH 510-4204182

  Show 50 Study Locations
Sponsors and Collaborators
Bionovo
Investigators
Study Director: Mary Tagliaferri, M.D, L.Ac. Bionovo Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Bionovo
ClinicalTrials.gov Identifier: NCT00906308     History of Changes
Other Study ID Numbers: MF-101-004
Study First Received: May 19, 2009
Last Updated: February 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Flushing
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014