Clinical trial NCT00906308: A Study of MF101 in Postmenopausal Women
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hot Flushes
Vasomotor Symptoms
Lead sponsor: Bionovo
Sponsor class: INDUSTRY
First posted: 2009-05-21
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research Center
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: San Diego
country: United States
facility: Genesis Center for Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Denver
country: United States
facility: Downtown Women's Health Care
state: Colorado
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Palm Harbor
country: United States
facility: Suncoast Clinical Research
state: Florida
city: St. Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: West Palm Beach
country: United States
facility: OB/GYN Specialists of the Palm Beaches
state: Florida
city: Decatur
country: United States
facility: Soapstone Center for Clinical Research
state: Georgia
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research
state: Georgia
city: Boise
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Springfield
country: United States
facility: Tufts University
state: Massachusetts
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center
state: New Mexico
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Hawthorne Medical Research
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research
state: Ohio
city: Columbus
country: United States
facility: Columbus Center for Women's Health Research
state: Ohio
city: Eugene
country: United States
facility: Clinical Trials of America
state: Oregon
city: Medford
country: United States
facility: Advanced Clinical Research - A Division of Medford Women's Clinic
state: Oregon
city: Jenkintown
country: United States
facility: The Clinical Trial Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Clinical Research
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Franklin
country: United States
facility: HCCA - Clinical Research Solutions
state: Tennessee
city: Jackson
country: United States
facility: HCCA - Clinical Research Solutions
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee at Memphis
state: Tennessee
city: Smyrna
country: United States
facility: HCCA - Clinical Research Solutions
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: Women Partners in Health/Professional Quality Research
state: Texas
city: Dallas
country: United States
facility: Discovery Clinical Trials
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research
state: Texas
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: National Clinical Research
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research Center
state: Virginia
city: Seattle
country: United States
facility: Seattle Women's Health, Research and Gynecology
state: Washington
Study officials:
affiliation: Bionovo Inc.
name: Mary Tagliaferri, M.D, L.Ac.
role: STUDY_DIRECTOR
References: