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

Primary Purpose

Sexual Dysfunctions, Psychological, Sexual Arousal Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sildenafil
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Dysfunctions, Psychological

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Safety/toleration of oral sildenafil.

Secondary Outcome Measures

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

Full Information

First Posted
March 31, 2008
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00746967
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunctions, Psychological, Sexual Arousal Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
sildenafil
Intervention Description
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 Outcome Measure Information:
Title
Safety/toleration of oral sildenafil.
Time Frame
Continuous
Secondary Outcome Measure Information:
Title
The score for each of the individual questions 3,5 and 9 on the SQoL-F
Time Frame
Week 14 and Week 26
Title
The total satisfaction score on the Inventory of Treatment Satisfaction (ITS-modified EDITS)
Time Frame
Week 14 and Week 26
Title
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
Title
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
Title
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
Title
The total Quality of Life score on the Sexual Quality of Life (SQoL-F)
Time Frame
Week 14 and Week 26
Title
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
Title
Question 16 from the SFQ at Weeks 14 and 26 (enjoyment of penetration and intercourse).
Time Frame
Week 14 and Week 26
Title
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
Title
The individual questions of the Orgasm domain.
Time Frame
Week 14 and Week 26
Title
SFQ Question 27 (confidence as sexual partner).
Time Frame
Week 14 and Week 26
Title
SFQ Question 29 (disappointment with response).
Time Frame
Week 14 and Week 26
Title
Global Efficacy Question (SFQ Question 34, satisfaction with whole of sexual life)
Time Frame
Week 14 and Week 26

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Pfizer Investigational Site
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99502
Country
United States
Facility Name
Pfizer Investigational Site
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Pfizer Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Pfizer Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Pfizer Investigational Site
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Pfizer Investigational Site
City
Albany
State/Province
California
ZIP/Postal Code
94706
Country
United States
Facility Name
Pfizer Investigational Site
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Pfizer Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Pfizer Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Pfizer Investigational Site
City
Burbank
State/Province
California
ZIP/Postal Code
91506
Country
United States
Facility Name
Pfizer Investigational Site
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
Pfizer Investigational Site
City
Hermosa Beach
State/Province
California
ZIP/Postal Code
90254
Country
United States
Facility Name
Pfizer Investigational Site
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Pfizer Investigational Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Pfizer Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Pfizer Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Pfizer Investigational Site
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Pfizer Investigational Site
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Pfizer Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Pfizer Investigational Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Pfizer Investigational Site
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34614
Country
United States
Facility Name
Pfizer Investigational Site
City
Jensen Beach
State/Province
Florida
ZIP/Postal Code
34957
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Pfizer Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Pfizer Investigational Site
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34683
Country
United States
Facility Name
Pfizer Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Pfizer Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Pfizer Investigational Site
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Facility Name
Pfizer Investigational Site
City
Stuart
State/Province
Florida
ZIP/Postal Code
34996
Country
United States
Facility Name
Pfizer Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Pfizer Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Pfizer Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Pfizer Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Pfizer Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Pfizer Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Pfizer Investigational Site
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Pfizer Investigational Site
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Pfizer Investigational Site
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Pfizer Investigational Site
City
Florence
State/Province
Kentucky
ZIP/Postal Code
41042
Country
United States
Facility Name
Pfizer Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70002
Country
United States
Facility Name
Pfizer Investigational Site
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
Pfizer Investigational Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Pfizer Investigational Site
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Pfizer Investigational Site
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Pfizer Investigational Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Pfizer Investigational Site
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Facility Name
Pfizer Investigational Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Pfizer Investigational Site
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Pfizer Investigational Site
City
White Plains
State/Province
New York
ZIP/Postal Code
10603
Country
United States
Facility Name
Pfizer Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Pfizer Investigational Site
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122-5402
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0559
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Facility Name
Pfizer Investigational Site
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19606
Country
United States
Facility Name
Pfizer Investigational Site
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19607-1649
Country
United States
Facility Name
Pfizer Investigational Site
City
Temple
State/Province
Pennsylvania
ZIP/Postal Code
19560
Country
United States
Facility Name
Pfizer Investigational Site
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611-1499
Country
United States
Facility Name
Pfizer Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
Pfizer Investigational Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Pfizer Investigational Site
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Pfizer Investigational Site
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Facility Name
Pfizer Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Pfizer Investigational Site
City
Cheyenne
State/Province
Wyoming
ZIP/Postal Code
82001
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481133&StudyName=An%20Open-Label%2C%20Extension%20Study%20Evaluating%20the%20Safety%2C%20Toleration%2C%20and%20Efficacy%20of%20Sildenafil%20in%20Women%20With%20Sexual%20Arousal%20Disorder.%0A
Description
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An Open-Label, Extension Study Evaluating the Safety, Toleration, and Efficacy of Sildenafil in Women With Sexual Arousal Disorder

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