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

Sexual Dysfunctions, Psychological Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746967
• Other study ID #: A1481133
• Status: Completed
• Phase: Phase 2
• Start date: January 2003
• Est. completion date: February 2004

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Sexual Arousal Disorder
• Sexual Dysfunctions, Psychological

Intervention

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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Albany	California
United States	Pfizer Investigational Site	Anchorage	Alaska
United States	Pfizer Investigational Site	Anchorage	Alaska
United States	Pfizer Investigational Site	Anderson	South Carolina
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Aventura	Florida
United States	Pfizer Investigational Site	Beachwood	Ohio
United States	Pfizer Investigational Site	Berkeley	California
United States	Pfizer Investigational Site	Beverly Hills	California
United States	Pfizer Investigational Site	Beverly Hills	California
United States	Pfizer Investigational Site	Boise	Idaho
United States	Pfizer Investigational Site	Boise	Idaho
United States	Pfizer Investigational Site	Brooksville	Florida
United States	Pfizer Investigational Site	Burbank	California
United States	Pfizer Investigational Site	Charlottesville	Virginia
United States	Pfizer Investigational Site	Cheyenne	Wyoming
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Crestview Hills	Kentucky
United States	Pfizer Investigational Site	Creve Coeur	Missouri
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Evansville	Indiana
United States	Pfizer Investigational Site	Fair Oaks	California
United States	Pfizer Investigational Site	Florence	Kentucky
United States	Pfizer Investigational Site	Fort Wayne	Indiana
United States	Pfizer Investigational Site	Greenbelt	Maryland
United States	Pfizer Investigational Site	Hamden	Connecticut
United States	Pfizer Investigational Site	Henderson	Nevada
United States	Pfizer Investigational Site	Hermosa Beach	California
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Huntsville	Alabama
United States	Pfizer Investigational Site	Jensen Beach	Florida
United States	Pfizer Investigational Site	Jonesboro	Arkansas
United States	Pfizer Investigational Site	Kalamazoo	Michigan
United States	Pfizer Investigational Site	Leawood	Kansas
United States	Pfizer Investigational Site	Marietta	Georgia
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Metairie	Louisiana
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	New Brunswick	New Jersey
United States	Pfizer Investigational Site	New London	Connecticut
United States	Pfizer Investigational Site	New Port Richey	Florida
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Newburgh	Indiana
United States	Pfizer Investigational Site	North Las Vegas	Nevada
United States	Pfizer Investigational Site	Oakland	California
United States	Pfizer Investigational Site	Palm Harbor	Florida
United States	Pfizer Investigational Site	Pembroke Pines	Florida
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Plantation	Florida
United States	Pfizer Investigational Site	Poughkeepsie	New York
United States	Pfizer Investigational Site	Providence	Rhode Island
United States	Pfizer Investigational Site	Reading	Pennsylvania
United States	Pfizer Investigational Site	Reading	Pennsylvania
United States	Pfizer Investigational Site	Renton	Washington
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Saint Petersburg	Florida
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Sandy	Utah
United States	Pfizer Investigational Site	Santa Monica	California
United States	Pfizer Investigational Site	Savannah	Georgia
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Southfield	Michigan
United States	Pfizer Investigational Site	Stuart	Florida
United States	Pfizer Investigational Site	Stuart	Florida
United States	Pfizer Investigational Site	Temple	Pennsylvania
United States	Pfizer Investigational Site	Torrance	California
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Waterbury	Connecticut
United States	Pfizer Investigational Site	West Palm Beach	Florida
United States	Pfizer Investigational Site	West Reading	Pennsylvania
United States	Pfizer Investigational Site	White Plains	New York
United States	Pfizer Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   To obtain contact information for a study center near you, click here.