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Completed

NCT Number: NCT00746967

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

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.

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Key information

Conditions

Sexual Dysfunctions, Psychological Mental Disorders Sexual Arousal Disorder

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sildenafil

Drug

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 outcomes

  1. Safety/toleration of oral sildenafil.

    Time frame: Continuous

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Sep 4, 2008
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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