The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms

NCT00401245

Last updated date
Study Location
Pfizer Investigational Site
Tucson, Arizona, 85710, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vasomotor Symptoms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Generally healthy, postmenopausal woman who seeks treatment for hot flushes.

- Meets 1 of the following: At least 12 months of spontaneous amenorrhea; At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL; At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). Hysterectomized without bilateral oophorectomy and with serum FSH levels >40 mIU/mL.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- History of a seizure disorder other than a single childhood febrile seizure.


- History or presence of clinically important hepatic or renal disease or other medical
disease.


- Presence or recent history of major depressive disorder, bipolar disorder, psychotic
disorder, or generalized anxiety disorder requiring therapy.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Vasomotor SymptomsStudy Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With Menopause
NCT00421031
  1. Montgomery, Alabama
  2. Peoria, Arizona
  3. San Diego, California
  4. Stanford, California
  5. Colorado Springs, Colorado
  6. Newark, Delaware
  7. Aventura, Florida
  8. Ft. Myers, Florida
  9. Inverness, Florida
  10. Miami, Florida
  11. New Port Richey, Florida
  12. Ocala, Florida
  13. Orange City, Florida
  14. Pinellas Park, Florida
  15. Tampa, Florida
  16. West Palm Beach, Florida
  17. West Venice, Florida
  18. Atlanta, Georgia
  19. Savannah, Georgia
  20. Newburgh, Indiana
  21. Lexington, Kentucky
  22. Shreveport, Louisiana
  23. Portland, Maine
  24. Chaska, Minnesota
  25. Jackson, Mississippi
  26. St. Louis, Missouri
  27. Billings, Montana
  28. Las Vegas, Nevada
  29. Reno, Nevada
  30. Albuquerque, New Mexico
  31. Albuquerque, New Mexico
  32. Winston-Salem, North Carolina
  33. Canton, Ohio
  34. Cincinnati, Ohio
  35. Cincinnati, Ohio
  36. Portland, Oregon
  37. Erie, Pennsylvania
  38. Wexford, Pennsylvania
  39. Greenville, South Carolina
  40. San Antonio, Texas
  41. Norfolk, Virginia
Female
0+
years
MULTIPLE SITES
Vasomotor SymptomsStudy Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women
NCT00683800
  1. Birmingham, Alabama
  2. Mobile, Alabama
  3. Montgomery, Alabama
  4. Glendale, Arizona
  5. Peoria, Arizona
  6. Tucson, Arizona
  7. Tucson, Arizona
  8. Tucson, Arizona
  9. Jonesboro, Arkansas
  10. Little Rock, Arkansas
  11. Little Rock, Arkansas
  12. San Diego, California
  13. San Diego, California
  14. San Diego, California
  15. Vista, California
  16. Walnut Creek, California
  17. Colorado Springs, Colorado
  18. Denver, Colorado
  19. Englewood, Colorado
  20. Longmont, Colorado
  21. New London, Connecticut
  22. Newark, Delaware
  23. Brooksville, Florida
  24. Clearwater, Florida
  25. Clearwater, Florida
  26. Daytona Beach, Florida
  27. Fort Myers, Florida
  28. Gainesville, Florida
  29. Lake Worth, Florida
  30. New Port Richey, Florida
  31. Palm Harbor, Florida
  32. Pembroke Pines, Florida
  33. South Miami, Florida
  34. Tampa, Florida
  35. West Palm Beach, Florida
  36. Atlanta, Georgia
  37. Decatur, Georgia
  38. Decatur, Georgia
  39. Savannah, Georgia
  40. Boise, Idaho
  41. Idaho Falls, Idaho
  42. Indianapolis, Indiana
  43. Indianapolis, Indiana
  44. South Bend, Indiana
  45. Overland Park, Kansas
  46. Lexington, Kentucky
  47. Louisville, Kentucky
  48. New Orleans, Louisiana
  49. Scarborough, Maine
  50. Ann Arbor, Michigan
  51. Brooklyn Center, Minnesota
  52. Creve Coeur, Missouri
  53. Billings, Montana
  54. Billings, Montana
  55. Lincoln, Nebraska
  56. Las Vegas, Nevada
  57. Las Vegas, Nevada
  58. Reno, Nevada
  59. Lebanon, New Hampshire
  60. New Brunswick, New Jersey
  61. Albuquerque, New Mexico
  62. New York, New York
  63. Winston-Salem, North Carolina
  64. Bismarck, North Dakota
  65. Fargo, North Dakota
  66. Jamestown, North Dakota
  67. Akron, Ohio
  68. Cincinnati, Ohio
  69. Cleveland, Ohio
  70. Englewood, Ohio
  71. Oklahoma City, Oklahoma
  72. Eugene, Oregon
  73. Medford, Oregon
  74. Erie, Pennsylvania
  75. Erie, Pennsylvania
  76. Jenkintown, Pennsylvania
  77. Philadelphia, Pennsylvania
  78. Pittsburgh, Pennsylvania
  79. Wexford, Pennsylvania
  80. Warwick, Rhode Island
  81. Greer, South Carolina
  82. Hilton Head Island, South Carolina
  83. Sioux Falls, South Dakota
  84. Sioux Falls, South Dakota
  85. Watertown, South Dakota
  86. Chattanooga, Tennessee
  87. Knoxville, Tennessee
  88. Nashville, Tennessee
  89. Dallas, Texas
  90. Houston, Texas
  91. Midland, Texas
  92. Plano, Texas
  93. San Antonio, Texas
  94. Waco, Texas
  95. Salt Lake City, Utah
  96. Sandy, Utah
  97. Burlington, Vermont
  98. Norfolk, Virginia
  99. Norfolk, Virginia
  100. Richmond, Virginia
  101. Seattle, Washington
  102. Menomonee Falls, Wisconsin
  103. Calgary, Alberta
  104. Coquitlam, British Columbia
  105. Surrey, British Columbia
  106. Winnipeg, Manitoba
  107. Antigonish, Nova Scotia
  108. Corunna, Ontario
  109. Ottawa, Ontario
  110. Sarnia, Ontario
  111. Toronto, Ontario
  112. Toronto, Ontario
  113. Toronto, Ontario
  114. Gatineau, Quebec
  115. L'Ancienne-Lorette, Quebec
  116. Pointe Claire, Quebec
  117. Saint-Janvier, Quebec
  118. Shawinigan, Quebec
  119. Sherbrooke, Quebec
  120. St-Romuald, Quebec
  121. Quebec,
Female
45 Years+
years
MULTIPLE SITES
Vasomotor SymptomsThe Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms
NCT00401245
  1. Tucson, Arizona
  2. Tucson, Arizona
  3. Beverly Hills, California
  4. Encinitas, California
  5. Foothill Ranch, California
  6. San Diego, California
  7. San Diego, California
  8. Upland, California
  9. Denver, Colorado
  10. Longmont, Colorado
  11. Clearwater, Florida
  12. Crystal River, Florida
  13. Deland, Florida
  14. Gainesville, Florida
  15. Lake Worth, Florida
  16. Miami, Florida
  17. Miami, Florida
  18. Miami, Florida
  19. Palm Harbor, Florida
  20. Tampa, Florida
  21. Idaho Falls, Idaho
  22. Champaign, Illinois
  23. Chicago, Illinois
  24. South Bend, Indiana
  25. Lexington, Kentucky
  26. Louisville, Kentucky
  27. Metairie, Louisiana
  28. Metairie, Louisiana
  29. Canton, Michigan
  30. Ypsilanti, Michigan
  31. Billings, Montana
  32. Omaha, Nebraska
  33. Las Vegas, Nevada
  34. Lebanon, New Hampshire
  35. New Brunswick, New Jersey
  36. Albuquerque, New Mexico
  37. Albuquerque, New Mexico
  38. New York, New York
  39. Chapel Hill, North Carolina
  40. Charlotte, North Carolina
  41. Winston-Salem, North Carolina
  42. Winston-Salem, North Carolina
  43. Bismarck, North Dakota
  44. Fargo, North Dakota
  45. Cleveland, Ohio
  46. Eugene, Oregon
  47. Pittsburgh, Pennsylvania
  48. Watertown, South Dakota
  49. Carrollton, Texas
  50. Houston, Texas
  51. Hurst, Texas
  52. Midland, Texas
  53. Norfolk, Virginia
  54. Norfolk, Virginia
  55. Seattle, Washington
  56. Calgary, Alberta
  57. Coquitlam, British Columbia
  58. Langley, British Columbia
  59. Surrey, British Columbia
  60. Winnipeg, Manitoba
  61. Winnipeg, Manitoba
  62. St. John's, Newfoundland and Labrador
  63. Newmarket, Ontario
  64. Sarnia, Ontario
  65. Toronto, Ontario
  66. Toronto, Ontario
  67. Toronto, Ontario
  68. Montreal, Quebec
  69. Pointe Claire, Quebec
  70. Shawinigan, Quebec
  71. Sherbrooke, Quebec
  72. St-Romuald, Quebec
  73. Quebec,
Female
18 Years+
years
MULTIPLE SITES
Vasomotor SymptomsStudy Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women
NCT00397176
Female
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms
Official Title  ICMJE The Effect of Dose Titration and Dose Tapering on the Tolerability of DVS SR in Women With Vasomotor Symptoms Associated With Menopause: The PRIMMUS (PRIstiq for Managing Menopause and Understanding Symptoms) Study
Brief Summary Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated with menopause. Nausea is the most common adverse event that is observed in clinical studies and is the main reason for discontinuation during the first week of therapy. Other adverse events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when subjects abruptly discontinue the medication. The purpose of this study is to evaluate several titration and tapering regimens of DVS SR to ensure a better tolerability profile at the start and completion of treatment. In addition, this study will provide a long posttreatment follow-up to assess any symptoms after treatment is discontinued.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vasomotor Symptoms
Intervention  ICMJE
  • Drug: desvenlafaxine succinate sustained release
    Titration 100 mg
  • Drug: desvenlafaxine succinate sustained release
    Titration 50 mg
  • Drug: desvenlafaxine succinate sustained release
    Titration 25 mg, 50mg
  • Drug: desvenlafaxine succinate sustained release
    Titration 25 mg
  • Drug: Placebo
    Tapering placebo
  • Drug: desvenlafaxine succinate sustained release
    Tapering 50 mg, placebo
  • Drug: desvenlafaxine succinate sustained release
    Tapering 50 mg, 25 mg
  • Drug: desvenlafaxine succinate sustained release
    Tapering 50 mg QOD
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Active Comparator: B
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Active Comparator: C
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Active Comparator: D
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Active Comparator: E
    Intervention: Drug: Placebo
  • Active Comparator: F
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Active Comparator: G
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Placebo Comparator: H
    Intervention: Drug: desvenlafaxine succinate sustained release
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2006)
500
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Generally healthy, postmenopausal woman who seeks treatment for hot flushes.
  • Meets 1 of the following: At least 12 months of spontaneous amenorrhea; At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL; At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). Hysterectomized without bilateral oophorectomy and with serum FSH levels >40 mIU/mL.

Exclusion Criteria:

  • History of a seizure disorder other than a single childhood febrile seizure.
  • History or presence of clinically important hepatic or renal disease or other medical disease.
  • Presence or recent history of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00401245
Other Study ID Numbers  ICMJE 3151A2-405
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP