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To demonstrate improved subjective sleep in women with insomnia secondary to perimenopause or menopause following treatment with 3 mg of eszopiclone.
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 randomized to either eszopiclone 3 mg or placebo nightly for four weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | eszopiclone 3 mg |
|
| 2 | Placebo Comparator | Placebo tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eszopiclone | Drug | eszopiclone 3 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| mean subjective SL | Week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| mean subjective WASO | Week 1 | |
| Mean subjective SL | Weeks 2, 3, 4 | |
| Mean subjective WASO |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17138773 | Derived | 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. |
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| Placebo | Drug | placebo tablet |
|
| Weeks 2, 3, 4 |
| Mean subjective TST | Weeks 1, 2, 3, 4 |
| Mean number of awakenings | Weeks 1, 2, 3, 4 |
| Sleep quality and depth | Weeks 1, 2, 3, and 4 |
| Daytime alertness | Weeks 1, 2, 3, and 4 |
| Ability to concentrate | Weeks 1, 2, 3, and 4 |
| Physical well-being | Weeks 1, 2, 3, and 4 |
| Ability to function | Weeks 1, 2, 3, and 4 |
| Mean subjective number of nocturnal awakenings due to hot flashes | Weeks 1, 2, 3, and 4 |
| Mean number of hot flashes per day | Weeks 1, 2, 3, and 4 |
| Mean number of nocturnal hot flashes per night | Weeks 1, 2, 3, and 4 |
| Mean severity of hot flashes | Weeks 1, 2, 3, and 4 |
| ESS score | Weeks 2 and 4 |
| ISI score | Weeks 2 and 4 |
| GCS score | Weeks 2 and 4 |
| SDS score | Week 4 |
| MenQOL score | Week 4 |
| MADRS score | Week 4 |
| Physician Global Assessment | Week 4 |
| withdrawal effects will be assessed for the ISI, ESS, MADRS, MenQOL, Greene Climacteric Scale, Sheehan Disability Scale, and Physician Global Assessment. | Week 5 |
| 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 |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D011725 | Pyridines |
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