Status:
COMPLETED
Sleep Quality in CHIMES (MF101)
Lead Sponsor:
Bionovo
Conditions:
Sleep Quality
Menopausal Symptoms
Eligibility:
FEMALE
40-60 years
Phase:
PHASE2
Brief Summary
Menopausal women often complain of difficulty sleeping and the transition from pre- to postmenopausal status is associated with an incresase in self-reported sleep disturbance. Hot flashes have been a...
Detailed Description
Specific Aims: 1. To determine the effect of MF101 (a combination of Chinese herbs) compared to placebo on change in sleep quality utilizing baseline and follow-up actigraphy obtained from a subset o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00454441
Start Date
February 1 2006
End Date
February 1 2007
Last Update
March 30 2007
Active Locations (2)
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1
University of California, San Francisco
San Francisco, California, United States
2
University of Minnesota Twin Cities Campus
Minneapolis, Minnesota, United States, 55415