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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00746967

Collaborator

(none)

267

Enrollment

Locations

Arm

Duration (Months)

3.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sexual Dysfunctions, Psychological Sexual Arousal Disorder	Drug: sildenafil	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

267 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2003

Actual Study Completion Date :

Feb 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Outcome Measures

Primary Outcome Measures

Safety/toleration of oral sildenafil. [Continuous]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Huntsville	Alabama	United States	35801
2	Pfizer Investigational Site	Anchorage	Alaska	United States	99502
3	Pfizer Investigational Site	Anchorage	Alaska	United States	99508
4	Pfizer Investigational Site	Tucson	Arizona	United States	85712
5	Pfizer Investigational Site	Tucson	Arizona	United States	85719
6	Pfizer Investigational Site	Jonesboro	Arkansas	United States	72401
7	Pfizer Investigational Site	Albany	California	United States	94706
8	Pfizer Investigational Site	Berkeley	California	United States	94705
9	Pfizer Investigational Site	Beverly Hills	California	United States	90210
10	Pfizer Investigational Site	Beverly Hills	California	United States	90212
11	Pfizer Investigational Site	Burbank	California	United States	91506
12	Pfizer Investigational Site	Fair Oaks	California	United States	95628
13	Pfizer Investigational Site	Hermosa Beach	California	United States	90254
14	Pfizer Investigational Site	Oakland	California	United States	94612
15	Pfizer Investigational Site	San Diego	California	United States	92103
16	Pfizer Investigational Site	San Diego	California	United States	92108
17	Pfizer Investigational Site	Santa Monica	California	United States	90404
18	Pfizer Investigational Site	Torrance	California	United States	90505
19	Pfizer Investigational Site	Aurora	Colorado	United States	80012
20	Pfizer Investigational Site	Hamden	Connecticut	United States	06518
21	Pfizer Investigational Site	New London	Connecticut	United States	06320
22	Pfizer Investigational Site	Waterbury	Connecticut	United States	06708
23	Pfizer Investigational Site	Aventura	Florida	United States	33180
24	Pfizer Investigational Site	Brooksville	Florida	United States	34614
25	Pfizer Investigational Site	Jensen Beach	Florida	United States	34957
26	Pfizer Investigational Site	Miami	Florida	United States	33186
27	Pfizer Investigational Site	New Port Richey	Florida	United States	34652
28	Pfizer Investigational Site	Palm Harbor	Florida	United States	34683
29	Pfizer Investigational Site	Pembroke Pines	Florida	United States	33028
30	Pfizer Investigational Site	Plantation	Florida	United States	33324
31	Pfizer Investigational Site	Saint Petersburg	Florida	United States	33710
32	Pfizer Investigational Site	Stuart	Florida	United States	34994
33	Pfizer Investigational Site	Stuart	Florida	United States	34996
34	Pfizer Investigational Site	West Palm Beach	Florida	United States	33409
35	Pfizer Investigational Site	Atlanta	Georgia	United States	30309
36	Pfizer Investigational Site	Atlanta	Georgia	United States	30342
37	Pfizer Investigational Site	Marietta	Georgia	United States	30060
38	Pfizer Investigational Site	Savannah	Georgia	United States	31405
39	Pfizer Investigational Site	Boise	Idaho	United States	83702
40	Pfizer Investigational Site	Boise	Idaho	United States	83712
41	Pfizer Investigational Site	Evansville	Indiana	United States	47714
42	Pfizer Investigational Site	Fort Wayne	Indiana	United States	46825
43	Pfizer Investigational Site	Newburgh	Indiana	United States	47630
44	Pfizer Investigational Site	Leawood	Kansas	United States	66211
45	Pfizer Investigational Site	Crestview Hills	Kentucky	United States	41017
46	Pfizer Investigational Site	Florence	Kentucky	United States	41042
47	Pfizer Investigational Site	Metairie	Louisiana	United States	70002
48	Pfizer Investigational Site	Greenbelt	Maryland	United States	20770
49	Pfizer Investigational Site	Kalamazoo	Michigan	United States	49009
50	Pfizer Investigational Site	Southfield	Michigan	United States	48034
51	Pfizer Investigational Site	Creve Coeur	Missouri	United States	63141
52	Pfizer Investigational Site	Henderson	Nevada	United States	89014
53	Pfizer Investigational Site	North Las Vegas	Nevada	United States	89030
54	Pfizer Investigational Site	New Brunswick	New Jersey	United States	08903
55	Pfizer Investigational Site	New York	New York	United States	10021
56	Pfizer Investigational Site	Poughkeepsie	New York	United States	12601
57	Pfizer Investigational Site	Rochester	New York	United States	14609
58	Pfizer Investigational Site	White Plains	New York	United States	10603
59	Pfizer Investigational Site	Winston-Salem	North Carolina	United States	27103
60	Pfizer Investigational Site	Beachwood	Ohio	United States	44122-5402
61	Pfizer Investigational Site	Cincinnati	Ohio	United States	45267-0559
62	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19106
63	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19148
64	Pfizer Investigational Site	Reading	Pennsylvania	United States	19606
65	Pfizer Investigational Site	Reading	Pennsylvania	United States	19607-1649
66	Pfizer Investigational Site	Temple	Pennsylvania	United States	19560
67	Pfizer Investigational Site	West Reading	Pennsylvania	United States	19611-1499
68	Pfizer Investigational Site	Providence	Rhode Island	United States	02904
69	Pfizer Investigational Site	Anderson	South Carolina	United States	29621
70	Pfizer Investigational Site	Memphis	Tennessee	United States	38119
71	Pfizer Investigational Site	Austin	Texas	United States	78705
72	Pfizer Investigational Site	Austin	Texas	United States	78758
73	Pfizer Investigational Site	Dallas	Texas	United States	75231
74	Pfizer Investigational Site	Houston	Texas	United States	77024
75	Pfizer Investigational Site	Sandy	Utah	United States	84070
76	Pfizer Investigational Site	Charlottesville	Virginia	United States	22903
77	Pfizer Investigational Site	Richmond	Virginia	United States	23294
78	Pfizer Investigational Site	Renton	Washington	United States	98055
79	Pfizer Investigational Site	Seattle	Washington	United States	98105
80	Pfizer Investigational Site	Seattle	Washington	United States	98115
81	Pfizer Investigational Site	Milwaukee	Wisconsin	United States	53209
82	Pfizer Investigational Site	Cheyenne	Wyoming	United States	82001

Sponsors and Collaborators

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

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT00746967

Other Study ID Numbers:

A1481133

First Posted:

Sep 4, 2008

Last Update Posted:

Feb 1, 2021

Last Verified:

Jan 1, 2021

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological

Sildenafil Citrate

Study Results

No Results Posted as of Feb 1, 2021