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

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Eszopiclone; Zopiclone

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.