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Trial record 1 of 1 for:    NCT00746967
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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.
 
ClinicalTrials.gov Identifier: NCT00746967
Recruitment Status : Completed
First Posted : September 4, 2008
Last Update Posted : September 4, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 31, 2008
First Posted Date  ICMJE September 4, 2008
Last Update Posted Date September 4, 2008
Study Start Date  ICMJE January 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
Safety/toleration of oral sildenafil. [ Time Frame: Continuous ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
  • The score for each of the individual questions 3,5 and 9 on the SQoL-F [ Time Frame: Week 14 and Week 26 ]
  • The total satisfaction score on the Inventory of Treatment Satisfaction (ITS-modified EDITS) [ Time Frame: Week 14 and Week 26 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • The total Quality of Life score on the Sexual Quality of Life (SQoL-F) [ Time Frame: 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). [ Time Frame: Week 14 and Week 26 ]
  • Question 16 from the SFQ at Weeks 14 and 26 (enjoyment of penetration and intercourse). [ Time Frame: 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). [ Time Frame: Week 14 and Week 26 ]
  • The individual questions of the Orgasm domain. [ Time Frame: Week 14 and Week 26 ]
  • SFQ Question 27 (confidence as sexual partner). [ Time Frame: Week 14 and Week 26 ]
  • SFQ Question 29 (disappointment with response). [ Time Frame: Week 14 and Week 26 ]
  • Global Efficacy Question (SFQ Question 34, satisfaction with whole of sexual life) [ Time Frame: Week 14 and Week 26 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2008

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