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Study of Eszopiclone Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause/Menopause

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00366093
Recruitment Status : Completed
First Posted : August 18, 2006
Last Update Posted : February 22, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Insomnia Drug: Eszopiclone Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 410 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Eszopiclone 3 mg Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause or Menopause
Study Start Date : February 2004
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
Drug Information available for: Eszopiclone

Arm Intervention/treatment
Experimental: 1
eszopiclone 3 mg
Drug: Eszopiclone
eszopiclone 3 mg
Other Names:
  • Lunesta
  • S-zopiclone

Placebo Comparator: 2
Placebo tablet
Drug: Placebo
placebo tablet

Primary Outcome Measures :
  1. mean subjective SL [ Time Frame: Week 1 ]

Secondary Outcome Measures :
  1. mean subjective WASO [ Time Frame: Week 1 ]
  2. Mean subjective SL [ Time Frame: Weeks 2, 3, 4 ]
  3. Mean subjective WASO [ Time Frame: Weeks 2, 3, 4 ]
  4. Mean subjective TST [ Time Frame: Weeks 1, 2, 3, 4 ]
  5. Mean number of awakenings [ Time Frame: Weeks 1, 2, 3, 4 ]
  6. Sleep quality and depth [ Time Frame: Weeks 1, 2, 3, and 4 ]
  7. Daytime alertness [ Time Frame: Weeks 1, 2, 3, and 4 ]
  8. Ability to concentrate [ Time Frame: Weeks 1, 2, 3, and 4 ]
  9. Physical well-being [ Time Frame: Weeks 1, 2, 3, and 4 ]
  10. Ability to function [ Time Frame: Weeks 1, 2, 3, and 4 ]
  11. Mean subjective number of nocturnal awakenings due to hot flashes [ Time Frame: Weeks 1, 2, 3, and 4 ]
  12. Mean number of hot flashes per day [ Time Frame: Weeks 1, 2, 3, and 4 ]
  13. Mean number of nocturnal hot flashes per night [ Time Frame: Weeks 1, 2, 3, and 4 ]
  14. Mean severity of hot flashes [ Time Frame: Weeks 1, 2, 3, and 4 ]
  15. ESS score [ Time Frame: Weeks 2 and 4 ]
  16. ISI score [ Time Frame: Weeks 2 and 4 ]
  17. GCS score [ Time Frame: Weeks 2 and 4 ]
  18. SDS score [ Time Frame: Week 4 ]
  19. MenQOL score [ Time Frame: Week 4 ]
  20. MADRS score [ Time Frame: Week 4 ]
  21. Physician Global Assessment [ Time Frame: Week 4 ]
  22. withdrawal effects will be assessed for the ISI, ESS, MADRS, MenQOL, Greene Climacteric Scale, Sheehan Disability Scale, and Physician Global Assessment. [ Time Frame: Week 5 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00366093

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Sponsors and Collaborators
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sunovion Identifier: NCT00366093    
Other Study ID Numbers: 190-054
First Posted: August 18, 2006    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Keywords provided by Sunovion:
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs