Study of Eszopiclone Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause/… (NCT00366093) | Clinical Trial Compass
CompletedPhase 3
Study of Eszopiclone Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause/Menopause
United States410 participantsStarted 2004-02
Plain-language summary
To demonstrate improved subjective sleep in women with insomnia secondary to perimenopause or menopause following treatment with 3 mg of eszopiclone.
Who can participate
Age range40 Years – 60 Years
SexFEMALE
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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 …