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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00746967
First received: March 31, 2008
Last updated: September 3, 2008
Last verified: September 2008
  Purpose

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 Intervention Phase
Sexual Dysfunctions, Psychological
Sexual Arousal Disorder
Drug: sildenafil
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety/toleration of oral sildenafil. [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The score for each of the individual questions 3,5 and 9 on the SQoL-F [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]
  • The total satisfaction score on the Inventory of Treatment Satisfaction (ITS-modified EDITS) [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The total Quality of Life score on the Sexual Quality of Life (SQoL-F) [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Question 16 from the SFQ at Weeks 14 and 26 (enjoyment of penetration and intercourse). [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The individual questions of the Orgasm domain. [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]
  • SFQ Question 27 (confidence as sexual partner). [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]
  • SFQ Question 29 (disappointment with response). [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]
  • Global Efficacy Question (SFQ Question 34, satisfaction with whole of sexual life) [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]

Enrollment: 267
Study Start Date: January 2003
Study Completion Date: February 2004
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746967

  Show 83 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00746967     History of Changes
Other Study ID Numbers: A1481133
Study First Received: March 31, 2008
Last Updated: September 3, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Disease
Sexual Dysfunctions, Psychological
Mental Disorders
Pathologic Processes
Sexual and Gender Disorders
Sildenafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014