Status:
COMPLETED
Study of Eszopiclone Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause/Menopause
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Insomnia
Eligibility:
FEMALE
40-60 years
Phase:
PHASE3
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 randomiz...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT00366093
Start Date
February 1 2004
End Date
January 1 2005
Last Update
February 22 2012
Active Locations (51)
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Mobile, Alabama, United States
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San Diego, California, United States
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Newington, Connecticut, United States