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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Sexual Dysfunctions, Psychological, Sexual Arousal Disorder

Intervention / Treatment
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* Drug: sildenafil


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br> | Drug: sildenafil<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/toleration of oral sildenafil. |  | Continuous | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The score for each of the individual questions 3,5 and 9 on the SQoL-F |  | Week 14 and Week 26 | 
| The total satisfaction score on the Inventory of Treatment Satisfaction (ITS-modified EDITS) |  | Week 14 and Week 26 | 
| The score for each of the individual questions 3,5,6 and 7 on the ITS-modified EDITS |  | Week 14 and Week 26 | 
| 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 |  | Week 14 and Week 26 | 
| 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. |  | Week 14 and Week 26 | 
| The total Quality of Life score on the Sexual Quality of Life (SQoL-F) |  | Week 14 and Week 26 | 
| 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). |  | Week 14 and Week 26 | 
| Question 16 from the SFQ at Weeks 14 and 26 (enjoyment of penetration and intercourse). |  | Week 14 and Week 26 | 
| 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). |  | Week 14 and Week 26 | 
| The individual questions of the Orgasm domain. |  | Week 14 and Week 26 | 
| SFQ Question 27 (confidence as sexual partner). |  | Week 14 and Week 26 | 
| SFQ Question 29 (disappointment with response). |  | Week 14 and Week 26 | 
| Global Efficacy Question (SFQ Question 34, satisfaction with whole of sexual life) |  | Week 14 and Week 26 |