NCT00119665

Brief Summary

The researchers propose a Phase II randomized, double-blind, placebo-controlled trial of 180 healthy postmenopausal women experiencing at least 5 hot flashes per day or 35 hot flashes per week. Women will be randomized to one of three arms: 4.5 grams/day (dry weight of extract) of MF101, 9.0 grams/day (dry weight of extract) of MF101 or placebo for 12 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

May 17, 2007

Status Verified

March 1, 2007

First QC Date

July 6, 2005

Last Update Submit

May 16, 2007

Conditions

Hot Flashes

Keywords

Postmenopausal symptomsHot FlashesPostmenopausal Hot Flashes

Outcome Measures

Primary Outcomes (1)

  • Frequency and severity of hot flashes

Interventions

MF101DRUG

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women between the ages of 40 to 60.
  • Currently receiving medical care from a health care provider.
  • Self-report 5 hot flashes per day or 35 hot flashes per week.
  • Postmenopausal as defined by 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \> 30mlU/ml or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy or hysterectomy with FSH levels \> 30 mlU/ml.
  • Agree not to start new herbal or dietary supplements and not to change the dose of any currently used herbal or dietary supplements for the duration of the trial.
  • Successful completion of a Hot Flash Diary, a Daily Study Medication Diary and a Bleeding Diary, tolerates placebo, and 80% compliant at run-in.
  • Must have had a mammogram within the last 9 months.
  • Have access to a phone.
  • Provide informed consent.

You may not qualify if:

  • Inability to sign an informed consent or fill out questionnaires.
  • History of breast, uterine or ovarian cancer or melanoma.
  • Abnormal mammogram or breast examination within the last 9 months suggestive of cancer.
  • Abnormal Pap smear or pelvic examination within the last 9 months suggestive of cancer.
  • Double-wall endometrial thickness that exceeds 5 mm measured on transvaginal ultrasound.
  • Unexplained abnormal uterine bleeding within six months of enrollment.
  • Pregnancy or lactating.
  • Clinical evidence of active ischemic cardiovascular disease or a history of cardiovascular disease.
  • History of deep vein thrombosis or pulmonary embolism requiring anticoagulation.
  • Active liver or gallbladder disease.
  • Use of medications, herbal or dietary supplements known to possibly be effective for the treatment of hot flashes within three months of enrollment for oral or transdermal drugs, or within 6 months of enrollment for implanted or injected drugs.
  • Use of raloxifene or tamoxifen within three months of enrollment.
  • Use of another investigational agent within 3 months of enrollment.
  • History of multiple or severe food or medicine allergies.
  • Any medical or psychiatric condition that, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the trial, including severe illness, plans to move, substance abuse, significant problems, or dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California, San Francisco

San Francisco, California, 94118, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55415, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Deborah Grady, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 6, 2005

First Posted

July 14, 2005

Study Start

February 1, 2006

Study Completion

February 1, 2007

Last Updated

May 17, 2007

Record last verified: 2007-03

Locations

US(4)