An Open-Label, Extension Study Evaluating the Safety, Toleration, and Efficacy of Sildenafil in Women With Sexual Arousal Disorder

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NCT00746967

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Study Location
Pfizer Investigational Site
Huntsville, Alabama, 35801, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Sexual Dysfunctions, Psychological, Sexual Arousal Disorder
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

- Included were subjects who completed Pfizer study A1481082 or A1481123 without a major protocol violation and with all treatment-related adverse events resolved prior to crossover into the open-label study.

- For subjects receiving hormone replacement therapy and/or selective serotonin reuptake inhibitor treatment, dosage of these must be stable at the start of this extension study and remain stable throughout.

- Subjects should continue to maintain a stable sexual relationship throughout the study.

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


- Excluded were subjects who experienced either treatment-related serious adverse events
or significant treatment-related laboratory abnormalities in the previous study, and
subjects who misused study medication and/or failed to adequately account for study
medication in the previous study, or who were non-compliant with visits.


- Also excluded were subjects who were currently prescribed and/or taking nitrates or
nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational
or aerosols).

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[email protected]

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Sexual Dysfunctions, Psychological, Sexual Arousal DisorderAn Open-Label, Extension Study Evaluating the Safety, Toleration, and Efficacy of Sildenafil in Women With Sexual Arousal Disorder
NCT00746967
  1. Huntsville, Alabama
  2. Anchorage, Alaska
  3. Anchorage, Alaska
  4. Tucson, Arizona
  5. Tucson, Arizona
  6. Jonesboro, Arkansas
  7. Albany, California
  8. Berkeley, California
  9. Beverly Hills, California
  10. Beverly Hills, California
  11. Burbank, California
  12. Fair Oaks, California
  13. Hermosa Beach, California
  14. Oakland, California
  15. San Diego, California
  16. San Diego, California
  17. Santa Monica, California
  18. Torrance, California
  19. Aurora, Colorado
  20. Hamden, Connecticut
  21. New London, Connecticut
  22. Waterbury, Connecticut
  23. Aventura, Florida
  24. Brooksville, Florida
  25. Jensen Beach, Florida
  26. Miami, Florida
  27. New Port Richey, Florida
  28. Palm Harbor, Florida
  29. Pembroke Pines, Florida
  30. Plantation, Florida
  31. St Petersburg, Florida
  32. Stuart, Florida
  33. Stuart, Florida
  34. West Palm Beach, Florida
  35. Atlanta, Georgia
  36. Atlanta, Georgia
  37. Marietta, Georgia
  38. Savannah, Georgia
  39. Boise, Idaho
  40. Boise, Idaho
  41. Evansville, Indiana
  42. Fort Wayne, Indiana
  43. Newburgh, Indiana
  44. Leawood, Kansas
  45. Crestview Hills, Kentucky
  46. Florence, Kentucky
  47. Metairie, Louisiana
  48. Greenbelt, Maryland
  49. Kalamazoo, Michigan
  50. Southfield, Michigan
  51. Creve Coeur, Missouri
  52. Henderson, Nevada
  53. North Las Vegas, Nevada
  54. New Brunswick, New Jersey
  55. New York, New York
  56. Poughkeepsie, New York
  57. Rochester, New York
  58. White Plains, New York
  59. Winston Salem, North Carolina
  60. Winston-Salem, North Carolina
  61. Beachwood, Ohio
  62. Cincinnati, Ohio
  63. Philadelphia, Pennsylvania
  64. Philadelphia, Pennsylvania
  65. Reading, Pennsylvania
  66. Reading, Pennsylvania
  67. Temple, Pennsylvania
  68. West Reading, Pennsylvania
  69. Providence, Rhode Island
  70. Anderson, South Carolina
  71. Memphis, Tennessee
  72. Austin, Texas
  73. Austin, Texas
  74. Dallas, Texas
  75. Houston, Texas
  76. Sandy, Utah
  77. Charlottesville, Virginia
  78. Richmond, Virginia
  79. Renton, Washington
  80. Seattle, Washington
  81. Seattle, Washington
  82. Milwaukee, Wisconsin
  83. Cheyenne, Wyoming
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE An Open-Label, Extension Study Evaluating the Safety, Toleration, and Efficacy of Sildenafil in Women With Sexual Arousal Disorder
Official Title  ICMJE An Open-Label, Multi-Center Extension Study To Evaluate The Safety, Toleration And Sustained Efficacy Of Oral Sildenafil Administered To Women Who Have Been Diagnosed With Female Sexual Arousal Disorder
Brief Summary The purpose of this study is to evaluate the safety and toleration of oral sildenafil administered as required by women with Female Sexual Arousal Disorder (FSAD) who successfully complete one of the following Pfizer-sponsored, 12-week, double-blinded clinical trials: A1481082 or A1481123. Addition of this 52-week open-label extension will increase the total duration of sildenafil exposure to 64 weeks. Sustained efficacy will also be evaluated after 3 and 6 months of open-label therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sexual Dysfunctions, Psychological
  • Sexual Arousal Disorder
Intervention  ICMJE Drug: sildenafil
sildenafil 50 mg (starting dose) tablet by mouth taken as needed 1 hour before anticipated sexual activity; the dose could be increased to 100 mg or decreased to 25 mg; the duration of therapy in this open-label study was 52 weeks
Study Arms  ICMJE Arm 1
Intervention: Drug: sildenafil
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: September 3, 2008)		267
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Included were subjects who completed Pfizer study A1481082 or A1481123 without a major protocol violation and with all treatment-related adverse events resolved prior to crossover into the open-label study.
  • For subjects receiving hormone replacement therapy and/or selective serotonin reuptake inhibitor treatment, dosage of these must be stable at the start of this extension study and remain stable throughout.
  • Subjects should continue to maintain a stable sexual relationship throughout the study.

Exclusion Criteria:

  • Excluded were subjects who experienced either treatment-related serious adverse events or significant treatment-related laboratory abnormalities in the previous study, and subjects who misused study medication and/or failed to adequately account for study medication in the previous study, or who were non-compliant with visits.
  • Also excluded were subjects who were currently prescribed and/or taking nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or aerosols).
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00746967
Other Study ID Numbers  ICMJE A1481133
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2021

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