Clinical trial NCT00746967: An Open-Label, Extension Study Evaluating the Safety, Toleration, and Efficacy of Sildenafil in Women With Sexual Arousal Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sexual Dysfunctions, Psychological
Sexual Arousal Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-04
Enrollment: 267
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Safety/toleration of oral sildenafil.
timeFrame: Continuous
Secondary outcomes:
measure: The score for each of the individual questions 3,5 and 9 on the SQoL-F
timeFrame: Week 14 and Week 26
measure: The total satisfaction score on the Inventory of Treatment Satisfaction (ITS-modified EDITS)
timeFrame: Week 14 and Week 26
measure: The score for each of the individual questions 3,5,6 and 7 on the ITS-modified EDITS
timeFrame: Week 14 and Week 26
measure: 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
timeFrame: Week 14 and Week 26
measure: 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.
timeFrame: Week 14 and Week 26
measure: The total Quality of Life score on the Sexual Quality of Life (SQoL-F)
timeFrame: Week 14 and Week 26
measure: 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).
timeFrame: Week 14 and Week 26
measure: Question 16 from the SFQ at Weeks 14 and 26 (enjoyment of penetration and intercourse).
timeFrame: Week 14 and Week 26
measure: 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).
timeFrame: Week 14 and Week 26
measure: The individual questions of the Orgasm domain.
timeFrame: Week 14 and Week 26
measure: SFQ Question 27 (confidence as sexual partner).
timeFrame: Week 14 and Week 26
measure: SFQ Question 29 (disappointment with response).
timeFrame: Week 14 and Week 26
measure: Global Efficacy Question (SFQ Question 34, satisfaction with whole of sexual life)
timeFrame: Week 14 and Week 26
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Anchorage
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Anchorage
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Jonesboro
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Albany
country: United States
facility: Pfizer Investigational Site
state: California
city: Berkeley
country: United States
facility: Pfizer Investigational Site
state: California
city: Beverly Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Beverly Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Burbank
country: United States
facility: Pfizer Investigational Site
state: California
city: Fair Oaks
country: United States
facility: Pfizer Investigational Site
state: California
city: Hermosa Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Oakland
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Monica
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Hamden
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New London
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Waterbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Aventura
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Brooksville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jensen Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Plantation
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Stuart
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Stuart
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Savannah
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Fort Wayne
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Newburgh
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Leawood
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Crestview Hills
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Florence
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Greenbelt
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Southfield
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Creve Coeur
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: North Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: New Brunswick
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: White Plains
country: United States
facility: Pfizer Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Reading
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Reading
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Temple
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: West Reading
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Anderson
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Sandy
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Renton
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Cheyenne
country: United States
facility: Pfizer Investigational Site
state: Wyoming
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: