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

Phase 2

Completed

Conditions: Sexual Dysfunctions, Psychological
Sexual Arousal Disorder

Interventions: Drug: sildenafil

Registration Number: NCT00746967

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

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 267

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	sildenafil	-

Primary Outcome Measures

Name	Time	Method
Safety/toleration of oral sildenafil.	Continuous

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): Pfizer Investigational Site
🇺🇸
Cheyenne, Wyoming, United States