A Study of MF101 in Postmenopausal Women

Vasomotor Symptoms Clinical Trial

— HERBA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00906308
• Other study ID #: MF-101-004
• Status: Recruiting
• Phase: Phase 3
• First received: May 19, 2009
• Last updated: February 6, 2012
• Start date: October 2011

Study information

• Verified date: February 2012
• Source: Bionovo
• Contact: Jesse Langon, MPH
• Phone: 510-4204182
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hot Flashes
• Hot Flushes
• Vasomotor Symptoms

Intervention

Drug:
• MF101 5 g/day
PO (orally) 5 g/day (administered twice a day, BID) for up to 12 weeks
• Placebo
PO (orally) matched placebo (administered twice a day, BID) for up to 12 weeks
• MF101 10 g/day
PO (orally) 10 g/day (administered twice a day, BID) for up to 12 weeks

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	New Mexico Clinical Research & Osteoporosis Center	Albuquerque	New Mexico
United States	Benchmark Research	Austin	Texas
United States	Women Partners in Health/Professional Quality Research	Austin	Texas
United States	Johns Hopkins University	Baltimore	Maryland
United States	Alta Bates Summit Medical Center	Berkeley	California
United States	Advanced Clinical Research	Boise	Idaho
United States	Visions Clinical Research	Boynton Beach	Florida
United States	Meridien Research	Bradenton	Florida
United States	Meridien Research	Brooksville	Florida
United States	University of Virginia	Charlottesville	Virginia
United States	Rapid Medical Research	Cleveland	Ohio
United States	South Carolina Clinical Research	Columbia	South Carolina
United States	Columbus Center for Women's Health Research	Columbus	Ohio
United States	Discovery Clinical Trials	Dallas	Texas
United States	Soapstone Center for Clinical Research	Decatur	Georgia
United States	Downtown Women's Health Care	Denver	Colorado
United States	Clinical Trials of America	Eugene	Oregon
United States	HCCA - Clinical Research Solutions	Franklin	Tennessee
United States	HCCA - Clinical Research Solutions	Jackson	Tennessee
United States	The Clinical Trial Center	Jenkintown	Pennsylvania
United States	R/D Clinical Research	Lake Jackson	Texas
United States	Advanced Clinical Research - A Division of Medford Women's Clinic	Medford	Oregon
United States	University of Tennessee at Memphis	Memphis	Tennessee
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Eastern Carolina Women's Center	New Bern	North Carolina
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Suncoast Clinical Research	New Port Richey	Florida
United States	National Clinical Research	Norfolk	Virginia
United States	Compass Research	Orlando	Florida
United States	Suncoast Clinical Research	Palm Harbor	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Arizona Research Center	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	PMG Research	Raleigh	North Carolina
United States	National Clinical Research Center	Richmond	Virginia
United States	Rochester Clinical Research	Rochester	New York
United States	Northern California Research	Sacramento	California
United States	Genesis Center for Clinical Research	San Diego	California
United States	Medical Center for Clinical Research	San Diego	California
United States	Mount Vernon Clinical Research	Sandy Springs	Georgia
United States	Seattle Women's Health, Research and Gynecology	Seattle	Washington
United States	HCCA - Clinical Research Solutions	Smyrna	Tennessee
United States	Tufts University	Springfield	Massachusetts
United States	Meridien Research	St. Petersburg	Florida
United States	Meridien Research	Tampa	Florida
United States	Visions Clinical Research Center	Tucson	Arizona
United States	Advanced Clinical Research	West Jordan	Utah
United States	OB/GYN Specialists of the Palm Beaches	West Palm Beach	Florida
United States	Hawthorne Medical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bionovo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo.	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.	12 weeks	Yes

External Links

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