Study of Eszopiclone Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause/Menopause
The Efficacy of Eszopiclone 3 mg Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause or Menopause
1 other identifier
interventional
410
1 country
51
Brief Summary
To demonstrate improved subjective sleep in women with insomnia secondary to perimenopause or menopause following treatment with 3 mg of eszopiclone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2004
Shorter than P25 for phase_3
51 active sites
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
Study Start
First participant enrolled
February 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 17, 2006
CompletedFirst Posted
Study publicly available on registry
August 18, 2006
CompletedFebruary 22, 2012
February 1, 2012
11 months
August 17, 2006
February 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mean subjective SL
Week 1
Secondary Outcomes (22)
mean subjective WASO
Week 1
Mean subjective SL
Weeks 2, 3, 4
Mean subjective WASO
Weeks 2, 3, 4
Mean subjective TST
Weeks 1, 2, 3, 4
Mean number of awakenings
Weeks 1, 2, 3, 4
- +17 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALeszopiclone 3 mg
2
PLACEBO COMPARATORPlacebo tablet
Interventions
Eligibility Criteria
You may qualify if:
- Subject must understand the purpose of the study and be willing to adhere to the study schedule and procedures described in this protocol.
- Subject must be between the ages of 40 and 60 years, inclusive, on the day of signing consent.
- Subject must have perimenopausal or menopausal signs and symptoms.
- Subject must report SL of \>45 minutes and \<6 hours of TST at least three times a week over the previous month and symptoms of insomnia must post date onset of perimenopausal or menopausal symptoms.
- Subject's physical exam must show no clinically significant abnormal findings (other than insomnia and menopause symptoms) at screening.
You may not qualify if:
- Subject has history of circadian rhythm disorder, or travels across \>3 time zones on a regular basis.
- Female subject is pregnant, lactating or within 6-months post partum.
- Subject has a history of drug or alcohol abuse or dependence in the past 2 years or positive urine drug test at screening .
- Subject has unstable medical abnormality, or unstable chronic disease; or history of significant cardiac, renal, or hepatic disease, seizure disorder, or current or past acute suicidal tendencies.
- Subject has participated in any investigational drug study within 30 days prior to screening or plans to participate in another investigational drug study during participation in this study.
- Subject is taking hormone replacement therapy or an hormonal contraceptive, and has not been on a stable dose for a minimum of 60 days prior to study start.
- Subject is known to be seropositive for HIV.
- Subject has a disorder or history of a condition (e.g., malabsorption, gastrointestinal surgery) that may interfere with drug absorption distribution, metabolism, or excretion.
- Subject has a history of malignancy within 5 years, or current malignancy, except for non-melanoma skin cancer.
- Subject has a diagnosis of any psychiatric disorder as identified by a psychiatric screening questionnaire.
- Subject has any primary diagnosis (personality disorder or mental retardation) that would impact the investigator's ability to evaluate the safety or efficacy of the study medication.
- Subject has difficulties in sleep initiation or maintenance associated with other known primary sleep disorders \[e.g. sleep apnea, restless leg syndrome (RLS), or periodic leg movement syndrome (PLMS)\], or has any condition that may affect sleep (e.g., chronic pain, urinary incontinence, etc.).
- Subject has used any drugs known or suspected to affect hepatic or renal clearance capacity within a period of 30 days prior to screening.
- Subject reports consumption of more than two alcoholic beverages daily, 14 or more alcoholic beverages weekly, or five or more alcoholic beverages on any given day.
- Subject is a rotating or third/night shift worker.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Newington, Connecticut, United States
Unknown Facility
Aventura, Florida, United States
Unknown Facility
Clearwater, Florida, United States
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Fort Meyers, Florida, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Melbourne, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Naples, Florida, United States
Unknown Facility
New Port Richey, Florida, United States
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Pembroke Pines, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
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Savannah, Georgia, United States
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Arlington Heights, Illinois, United States
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Champaign, Illinois, United States
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Chicago, Illinois, United States
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Lexington, Kentucky, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Brockton, Massachusetts, United States
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Ann Arbor, Michigan, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Reno, Nevada, United States
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Rochester, New York, United States
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Cary, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
Unknown Facility
Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Mentor, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Erie, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Columbia, South Carolina, United States
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Cordova, Tennessee, United States
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Houston, Texas, United States
Unknown Facility
Irving, Texas, United States
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Sandy City, Utah, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Renton, Washington, United States
Unknown Facility
Seatle, Washington, United States
Unknown Facility
Spokane, Washington, United States
Unknown Facility
Tacoma, Washington, United States
Related Publications (1)
Soares CN, Joffe H, Rubens R, Caron J, Roth T, Cohen L. Eszopiclone in patients with insomnia during perimenopause and early postmenopause: a randomized controlled trial. Obstet Gynecol. 2006 Dec;108(6):1402-10. doi: 10.1097/01.AOG.0000245449.97365.97.
PMID: 17138773DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2006
First Posted
August 18, 2006
Study Start
February 1, 2004
Primary Completion
January 1, 2005
Study Completion
January 1, 2005
Last Updated
February 22, 2012
Record last verified: 2012-02