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

Completed · Phase 3 · Has a placebo group

Conditions studied: Insomnia

In brief

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

Key facts

Study ID

NCT00366093

Run by

Sumitomo Pharma America, Inc.

People needed

410

Starts

2004-02-01

Expected to finish

2005-01-01

Last updated by the study team

2012-02-22

Who can join

Age: 40 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Newington, Connecticut, United States
• Study site — Aventura, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Fort Meyers, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Melbourne, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Naples, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Arlington Heights, Illinois, United States
• Study site — Champaign, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Boston, Massachusetts, United States
• Study site — Brockton, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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