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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00746967
Recruitment Status : Completed
First Posted : September 4, 2008
Last Update Posted : September 4, 2008
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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.

Condition or disease Intervention/treatment Phase
Sexual Dysfunctions, Psychological Sexual Arousal Disorder Drug: sildenafil Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2003
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Arm 1 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

Primary Outcome Measures :
  1. Safety/toleration of oral sildenafil. [ Time Frame: Continuous ]

Secondary Outcome Measures :
  1. The score for each of the individual questions 3,5 and 9 on the SQoL-F [ Time Frame: Week 14 and Week 26 ]
  2. The total satisfaction score on the Inventory of Treatment Satisfaction (ITS-modified EDITS) [ Time Frame: Week 14 and Week 26 ]
  3. The score for each of the individual questions 3,5,6 and 7 on the ITS-modified EDITS [ Time Frame: Week 14 and Week 26 ]
  4. The Arousal-lubrication Domain from the SFQ. The score for this domain is the sum of scores from Questions 11 and 12 from the SFQ [ Time Frame: Week 14 and Week 26 ]
  5. The Arousal-sensation Domain from the SFQ. The score for this domain is sum of scores from Questions 7,8,9 and 10 from the SFQ. [ Time Frame: Week 14 and Week 26 ]
  6. The total Quality of Life score on the Sexual Quality of Life (SQoL-F) [ Time Frame: Week 14 and Week 26 ]
  7. The Desire domain from the SFQ. Specifically, the sum of scores from questions 1,2,3,4,15 and 28 (frequency of pleasurable thoughts, wanted to be touched, wanted sex, initiated sex, had sex with penetration, looked forward to sex, respectively). [ Time Frame: Week 14 and Week 26 ]
  8. Question 16 from the SFQ at Weeks 14 and 26 (enjoyment of penetration and intercourse). [ Time Frame: Week 14 and Week 26 ]
  9. The Orgasm domain from the SFQ. The score for this domain is the sum of scores from questions 24,25 and 26 (orgasm frequency, level of pleasure and ease in achieving, respectively). [ Time Frame: Week 14 and Week 26 ]
  10. The individual questions of the Orgasm domain. [ Time Frame: Week 14 and Week 26 ]
  11. SFQ Question 27 (confidence as sexual partner). [ Time Frame: Week 14 and Week 26 ]
  12. SFQ Question 29 (disappointment with response). [ Time Frame: Week 14 and Week 26 ]
  13. Global Efficacy Question (SFQ Question 34, satisfaction with whole of sexual life) [ Time Frame: Week 14 and Week 26 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00746967

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00746967     History of Changes
Other Study ID Numbers: A1481133
First Posted: September 4, 2008    Key Record Dates
Last Update Posted: September 4, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
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Sexual Dysfunctions, Psychological
Pathologic Processes
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents