CClinicalTrials.gg
Sign In
CompletedNCT00454441Updated Mar 30, 2007

Sleep Quality in CHIMES (MF101)

A Phase 2 interventional study of MF101 in Sleep Quality and Menopausal Symptoms, sponsored by Bionovo. Completed at 2 sites in United States. Open to female participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-03-30.

Sponsored by Bionovo · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
Female
01

Study 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 associated with self-reported measures of sleep disturbance and changes in sleep pattern as measured by plysomnography, including an increase in stage 4 and a latency or shortened time in rapid-eye movement sleep. Although there are some data on the effect of hormone replacement therapy on self-reported sleep measures in symptomatic postmenopausal women, there are no data on the effect of herbal extracts on subjective or objective measures of sleep quality in this population group. Actigraphy, the use of a device to record movement generally placed on the wrist, has been used over 20 years to provide objective data concerning sleep/wake patterns. The advantage of actigraphy over traditional polysomnography is that actigraphy can conveniently record continuously for 24-hours a day for longer periods of time.

Read the 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 of approximately 90 women enrolled in the randomized, double-blind, placebo-controlled Chinese Herbs for Menopausal Symptoms (CHIMES) trial.
  2. TO identify the correlates of sleep quality as assessed by actigraphy in women with frequent hot flashes. We will evaluate demographic, lifestyle, anthropometric, medical and gynecologic history and hormonal factors that may relate to the actigraphic measures of sleep quality, including self-reported measures of sleep.
02

Conditions studied

  • Sleep Quality
  • Menopausal Symptoms

Keywords

  • Sleep Quality
  • Menopausal Symptoms
  • Actigraph
  • Bionovo
  • MF101
03

In context

Lead sponsor

Bionovo is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
180 participants

Interventions

  • DrugMF101
06

What researchers measure

Primary outcomes

  1. Actigraph watch (SleepWatch-O, Ambulatory Monitoring, Inc., Ardsley, NY)

07

Study locations

2 sites
  • University of California, San Francisco
    San Francisco, California, United States
  • University of Minnesota Twin Cities Campus
    Minneapolis, Minnesota 55415, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00454441
Lead sponsor
Bionovo
First posted
Mar 30, 2007
Start date
Feb 2006
Completion
Feb 2007
Last update
Mar 30, 2007

Study contacts

Kristine Ensrud, MD, MPH
principal investigator · University of Minnesota Twin Cities Campus
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Bionovo

Start the discussion