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InsomniaPhase 3NCT00366093

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

A Phase 3 study testing Eszopiclone in people with Insomnia, run by Sumitomo Pharma America, Inc. at 51 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 40 to 60 years, women only
Conditions the study is for
Insomnia
What is being tested?
Eszopiclone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
410 participants
Where
51 sitesUnited States
Study dates
Feb 2004to Jan 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

United States51 sites

  • Study site

    Ann Arbor, Michigan

  • Study site

    Arlington Heights, Illinois

  • Study site

    Atlanta, Georgia

  • Study site

    Aventura, Florida

  • Study site

    Boston, Massachusetts

  • Study site

    Brockton, Massachusetts

  • Study site

    Cary, North Carolina

  • Study site

    Champaign, Illinois

  • Study site

    Chicago, Illinois

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Cordova, Tennessee

  • Study site

    Dayton, Ohio

  • Study site

    Denver, Colorado

  • Study site

    Erie, Pennsylvania

  • Study site

    Fort Meyers, Florida

  • Study site

    Gainesville, Florida

  • Study site

    Houston, Texas

  • Study site

    Irving, Texas

  • Study site

    Lexington, Kentucky

  • Study site

    Lincoln, Nebraska

  • Study site

    Louisville, Kentucky

  • Study site

    Medford, Oregon

  • Study site

    Melbourne, Florida

  • Study site

    Mentor, Ohio

  • Study site

    Miami, Florida

  • Study site

    Mobile, Alabama

  • Study site

    Naples, Florida

  • Study site

    New Port Richey, Florida

  • Study site

    Newington, Connecticut

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Pembroke Pines, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Raleigh, North Carolina

  • Study site

    Reno, Nevada

  • Study site

    Renton, Washington

  • Study site

    Richmond, Virginia

  • Study site

    Rochester, New York

  • Study site

    San Diego, California

  • Study site

    Sandy City, Utah

  • Study site

    Savannah, Georgia

  • Study site

    Seatle, Washington

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Tacoma, Washington

  • Study site

    Tampa, Florida

  • Study site

    Warwick, Rhode Island

  • Study site

    West Palm Beach, Florida

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: The Efficacy of Eszopiclone 3 mg Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause or Menopause

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

Read the detailed description

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.

Conditions
Insomnia
Being tested
Eszopiclone, Placebo
Keywords
Menopause, Perimenopause
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EszopicloneDrug

    Also called Lunesta, S-zopiclone

    eszopiclone 3 mg

  • PlaceboDrug

    placebo tablet

Study groups in NCT00366093
Study groupRoleWhat they receive
1Experimentaleszopiclone 3 mg
Receives: Drug: Eszopiclone
2Placebo comparatorPlacebo tablet
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mean subjective SL

    Measured: Week 1

Secondary outcomes (22)

  1. mean subjective WASO

    Measured: Week 1

  2. Mean subjective SL

    Measured: Weeks 2, 3, 4

  3. Mean subjective WASO

    Measured: Weeks 2, 3, 4

  4. Mean subjective TST

    Measured: Weeks 1, 2, 3, 4

  5. Mean number of awakenings

    Measured: Weeks 1, 2, 3, 4

  6. Sleep quality and depth

    Measured: Weeks 1, 2, 3, and 4

  7. Daytime alertness

    Measured: Weeks 1, 2, 3, and 4

  8. Ability to concentrate

    Measured: Weeks 1, 2, 3, and 4

  9. Physical well-being

    Measured: Weeks 1, 2, 3, and 4

  10. Ability to function

    Measured: Weeks 1, 2, 3, and 4

  11. Mean subjective number of nocturnal awakenings due to hot flashes

    Measured: Weeks 1, 2, 3, and 4

  12. Mean number of hot flashes per day

    Measured: Weeks 1, 2, 3, and 4

  13. Mean number of nocturnal hot flashes per night

    Measured: Weeks 1, 2, 3, and 4

  14. Mean severity of hot flashes

    Measured: Weeks 1, 2, 3, and 4

  15. ESS score

    Measured: Weeks 2 and 4

  16. ISI score

    Measured: Weeks 2 and 4

  17. GCS score

    Measured: Weeks 2 and 4

  18. SDS score

    Measured: Week 4

  19. MenQOL score

    Measured: Week 4

  20. MADRS score

    Measured: Week 4

  21. Physician Global Assessment

    Measured: Week 4

  22. withdrawal effects will be assessed for the ISI, ESS, MADRS, MenQOL, Greene Climacteric Scale, Sheehan Disability Scale, and Physician Global Assessment.

    Measured: Week 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2006 (estimated)
  2. Study startFeb 2004
  3. Primary completionJan 2005
  4. Study completionJan 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
410 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00366093
Sponsor's protocol ID
190-054
Status last verified
Feb 2012
First submitted
17 Aug 2006
Last updated
22 Feb 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17138773

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eszopiclone in people with Insomnia, run by Sumitomo Pharma America, Inc. at 51 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mean subjective SL (time frame: Week 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00366093, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.

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