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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00906308
Other study ID # MF-101-004
Secondary ID
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. completion date
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


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
See also
  Status Clinical Trial Phase
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Completed NCT01052454 - Mindfulness-Based Stress Reduction for Hot Flashes Phase 0
Completed NCT00535288 - Dose-Finding Safety and Efficacy Trial of Org 50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (177001/P06472/MK-8265-013) Phase 3
Completed NCT01452373 - Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women Phase 3
Completed NCT00560833 - Dose-Finding Safety and Efficacy Trial of Org50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (46101/P06459/MK-8265-012) Phase 3
Completed NCT05033886 - A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause Phase 3
Completed NCT05083884 - A Survey About Hot Flashes in Women Going Through the Menopause
Completed NCT01178892 - MsFLASH-02: Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation N/A
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Recruiting NCT06122181 - Study of HS-10384 in Participants of Chinese Postmenopausal Women Phase 1
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Withdrawn NCT02202707 - Vasomotor Symptoms and Cardiovascular Control N/A
Completed NCT00356447 - Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms. Phase 3
Completed NCT05312567 - FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms Phase 2
Terminated NCT01353963 - Desvenlafaxine Succinate (Pristiq): Postmarketing Surveillance Study Among Filipino Patients Phase 4
Completed NCT00446199 - Low-dose Hormone Therapy for Relief of Vasomotor Symptoms Phase 3
Completed NCT05850338 - Determination of the Effects of Autogenic Relaxation Exercise and Cold Pillow Application on Vasomotor Symptom Control and Quality of Life in Postmenopausal Women N/A
Completed NCT02803268 - A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms Phase 1
Completed NCT00683800 - Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women Phase 3
Completed NCT03512002 - HIRREM Hot Flashes Study N/A

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