Clinical trial NCT00366093: Study of Eszopiclone Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause/Menopause
Official title: The Efficacy of Eszopiclone 3 mg Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause or Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Keywords: Menopause
Perimenopause
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2006-08-18
Enrollment: 410
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate improved subjective sleep in women with insomnia secondary to perimenopause or menopause following treatment with 3 mg of eszopiclone.

Detailed description: A multicenter, randomized, double-blind, placebo-controlled, parallel-group study of eszopiclone 3 mg in women with insomnia secondary to perimenopause or menopause. Eligible subjects will be randomized to either eszopiclone 3 mg or placebo nightly for four weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility criteria: Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* Subject is a staff member or relative of a staff member.
* Subject is experiencing symptoms of premature menopause or surgical menopause.
* Subject has discontinued hormone replacement therapy or a hormonal contraceptive, and has not been off treatment for a minimum of 60 days prior to study start.
* Subject has been on hormone replacement therapy or hormonal contraceptives for greater then one year.

Primary outcomes:
measure: mean subjective SL
timeFrame: Week 1
Secondary outcomes:
measure: mean subjective WASO
timeFrame: Week 1
measure: Mean subjective SL
timeFrame: Weeks 2, 3, 4
measure: Mean subjective WASO
timeFrame: Weeks 2, 3, 4
measure: Mean subjective TST
timeFrame: Weeks 1, 2, 3, 4
measure: Mean number of awakenings
timeFrame: Weeks 1, 2, 3, 4
measure: Sleep quality and depth
timeFrame: Weeks 1, 2, 3, and 4
measure: Daytime alertness
timeFrame: Weeks 1, 2, 3, and 4
measure: Ability to concentrate
timeFrame: Weeks 1, 2, 3, and 4
measure: Physical well-being
timeFrame: Weeks 1, 2, 3, and 4
measure: Ability to function
timeFrame: Weeks 1, 2, 3, and 4
measure: Mean subjective number of nocturnal awakenings due to hot flashes
timeFrame: Weeks 1, 2, 3, and 4
measure: Mean number of hot flashes per day
timeFrame: Weeks 1, 2, 3, and 4
measure: Mean number of nocturnal hot flashes per night
timeFrame: Weeks 1, 2, 3, and 4
measure: Mean severity of hot flashes
timeFrame: Weeks 1, 2, 3, and 4
measure: ESS score
timeFrame: Weeks 2 and 4
measure: ISI score
timeFrame: Weeks 2 and 4
measure: GCS score
timeFrame: Weeks 2 and 4
measure: SDS score
timeFrame: Week 4
measure: MenQOL score
timeFrame: Week 4
measure: MADRS score
timeFrame: Week 4
measure: Physician Global Assessment
timeFrame: Week 4
measure: withdrawal effects will be assessed for the ISI, ESS, MADRS, MenQOL, Greene Climacteric Scale, Sheehan Disability Scale, and Physician Global Assessment.
timeFrame: Week 5
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Newington
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state: Connecticut
city: Aventura
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state: Florida
city: Clearwater
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state: Florida
city: Ft. Meyers
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Arlington Heights
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state: Illinois
city: Champaign
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state: Illinois
city: Chicago
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state: Illinois
city: Lexington
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state: Kentucky
city: Louisville
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state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Brockton
country: United States
state: Massachusetts
city: Ann Arbor
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state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Reno
country: United States
state: Nevada
city: Rochester
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Mentor
country: United States
state: Ohio
city: Oklahoma City
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state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Erie
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburg
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Columbia
country: United States
state: South Carolina
city: Cordova
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Sandy
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Renton
country: United States
state: Washington
city: Seatle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
Study officials:
References:
citation: 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.