Study of Eszopiclone Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause/Menopause
NCT ID: NCT00366093
Last Updated: 2012-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
410 participants
INTERVENTIONAL
2004-02-29
2005-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Myo-inositol Plus Melatonin in Perimenopausal Women
NCT01325389
Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause
NCT02638337
A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause
NCT06112756
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Japanese Women Going Through Menopause
NCT06206408
Dose-Finding Safety and Efficacy Trial of Org 50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (177001/P06472/MK-8265-013)
NCT00535288
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
eszopiclone 3 mg
Eszopiclone
eszopiclone 3 mg
2
Placebo tablet
Placebo
placebo tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Eszopiclone
eszopiclone 3 mg
Placebo
placebo tablet
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
40 Years
60 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mobile, Alabama, United States
San Diego, California, United States
Denver, Colorado, United States
Newington, Connecticut, United States
Aventura, Florida, United States
Clearwater, Florida, United States
Fort Meyers, Florida, United States
Gainesville, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
New Port Richey, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Savannah, Georgia, United States
Arlington Heights, Illinois, United States
Champaign, Illinois, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Brockton, Massachusetts, United States
Ann Arbor, Michigan, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Reno, Nevada, United States
Rochester, New York, United States
Cary, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Mentor, Ohio, United States
Oklahoma City, Oklahoma, United States
Medford, Oregon, United States
Erie, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Warwick, Rhode Island, United States
Columbia, South Carolina, United States
Cordova, Tennessee, United States
Houston, Texas, United States
Irving, Texas, United States
Sandy City, Utah, United States
Richmond, Virginia, United States
Renton, Washington, United States
Seatle, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Soares CN, Joffe H, Rubens R, Caron J, Roth T, Cohen L. Eszopiclone in patients with insomnia during perimenopause and early postmenopause: a randomized controlled trial. Obstet Gynecol. 2006 Dec;108(6):1402-10. doi: 10.1097/01.AOG.0000245449.97365.97.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
190-054
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.