Recruiting
Phase 3

MF101

Sponsor:

Bionovo

Code:

NCT00906308

Conditions

Hot Flushes

Vasomotor Symptoms

Eligibility Criteria

Sex: Female

Age: 40 - 65

Healthy Volunteers: Accepted

Interventions

MF101 5 g/day

Placebo

MF101 10 g/day

Study Details

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.

Conditions

Hot Flushes

Vasomotor Symptoms

Study ID

NCT00906308

Start date

Oct, 2011

Status verified date

Feb, 2012

Primary completion date

Feb, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 65

Healthy Volunteers: Accepted

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

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

experimental: MF101 5 g/day

experimental: MF101 10 g/day

Interventions

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

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 ]

Central Contacts and Locations

Central contacts

Jesse Langon, MPH

510-4204182

Locations

Arizona Research Center

Recruiting

Phoenix, Arizona, United States

Visions Clinical Research Center

Recruiting

Tucson, Arizona, United States

Alta Bates Summit Medical Center

Recruiting

Berkeley, California, United States

Northern California Research

Recruiting

Sacramento, California, United States

Medical Center for Clinical Research

Recruiting

San Diego, California, United States

Downtown Women's Health Care

Recruiting

Denver, Colorado, United States

Visions Clinical Research

Recruiting

Boynton Beach, Florida, United States

Meridien Research

Recruiting

Bradenton, Florida, United States

Meridien Research

Recruiting

Brooksville, Florida, United States

Suncoast Clinical Research

Recruiting

New Port Richey, Florida, United States

Compass Research

Recruiting

Orlando, Florida, United States

Suncoast Clinical Research

Recruiting

Palm Harbor, Florida, United States

Meridien Research

Recruiting

St. Petersburg, Florida, United States

Meridien Research

Recruiting

Tampa, Florida, United States

OB/GYN Specialists of the Palm Beaches

Recruiting

West Palm Beach, Florida, United States

Soapstone Center for Clinical Research

Recruiting

Decatur, Georgia, United States

Mount Vernon Clinical Research

Recruiting

Sandy Springs, Georgia, United States

Advanced Clinical Research

Recruiting

Boise, Idaho, United States

Albuquerque Clinical Trials

Recruiting

Albuquerque, New Mexico, United States

New Mexico Clinical Research & Osteoporosis Center

Recruiting

Albuquerque, New Mexico, United States

Rochester Clinical Research

Recruiting

Rochester, New York, United States

Eastern Carolina Women's Center

Recruiting

New Bern, North Carolina, United States

PMG Research

Recruiting

Raleigh, North Carolina, United States

Hawthorne Medical Research

Recruiting

Winston-Salem, North Carolina, United States

Rapid Medical Research

Recruiting

Cleveland, Ohio, United States

Columbus Center for Women's Health Research

Recruiting

Columbus, Ohio, United States

Clinical Trials of America

Recruiting

Eugene, Oregon, United States

Advanced Clinical Research - A Division of Medford Women's Clinic

Recruiting

Medford, Oregon, United States

The Clinical Trial Center

Recruiting

Jenkintown, Pennsylvania, United States

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States

South Carolina Clinical Research

Recruiting

Columbia, South Carolina, United States

Coastal Carolina Research Center

Recruiting

Mt. Pleasant, South Carolina, United States

HCCA - Clinical Research Solutions

Recruiting

Franklin, Tennessee, United States

HCCA - Clinical Research Solutions

Recruiting

Jackson, Tennessee, United States

HCCA - Clinical Research Solutions

Recruiting

Smyrna, Tennessee, United States

Benchmark Research

Recruiting

Austin, Texas, United States

Women Partners in Health/Professional Quality Research

Recruiting

Austin, Texas, United States

Discovery Clinical Trials

Recruiting

Dallas, Texas, United States

R/D Clinical Research

Recruiting

Lake Jackson, Texas, United States

Advanced Clinical Research

Recruiting

West Jordan, Utah, United States

University of Virginia

Recruiting

Charlottesville, Virginia, United States

National Clinical Research

Recruiting

Norfolk, Virginia, United States

National Clinical Research Center

Recruiting

Richmond, Virginia, United States

Seattle Women's Health, Research and Gynecology

Recruiting

Seattle, Washington, United States

More Information

Sponsor

Bionovo

Last update posted

Feb 8, 2012

Last verified

Feb, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Bionovo on 2012-02-08.