Sexual Dysfunctions, PsychologicalPhase 2NCT00746967

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

A Phase 2 study testing sildenafil in people with Sexual Dysfunctions, Psychological and Sexual Arousal Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 82 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Sexual Dysfunctions, Psychological, Sexual Arousal Disorder
What is being tested?: sildenafil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 267 participants
Where: 82 sitesUnited States
Study dates: Jan 2003to Feb 2004
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

82 sites in 1 country.

City, postcode or hospital

82 sites in 1 country

United States82 sites

Pfizer Investigational Site
Albany, California, 94706
Pfizer Investigational Site
Anchorage, Alaska, 99502
Pfizer Investigational Site
Anchorage, Alaska, 99508
Pfizer Investigational Site
Anderson, South Carolina, 29621
Pfizer Investigational Site
Atlanta, Georgia, 30309
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Aurora, Colorado, 80012
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Austin, Texas, 78758
Pfizer Investigational Site
Aventura, Florida, 33180
Pfizer Investigational Site
Beachwood, Ohio, 44122-5402
Pfizer Investigational Site
Berkeley, California, 94705
Pfizer Investigational Site
Beverly Hills, California, 90210
Pfizer Investigational Site
Beverly Hills, California, 90212
Pfizer Investigational Site
Boise, Idaho, 83702
Pfizer Investigational Site
Boise, Idaho, 83712
Pfizer Investigational Site
Brooksville, Florida, 34614
Pfizer Investigational Site
Burbank, California, 91506
Pfizer Investigational Site
Charlottesville, Virginia, 22903
Pfizer Investigational Site
Cheyenne, Wyoming, 82001
Pfizer Investigational Site
Cincinnati, Ohio, 45267-0559
Pfizer Investigational Site
Crestview Hills, Kentucky, 41017
Pfizer Investigational Site
Creve Coeur, Missouri, 63141
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Evansville, Indiana, 47714
Pfizer Investigational Site
Fair Oaks, California, 95628
Pfizer Investigational Site
Florence, Kentucky, 41042
Pfizer Investigational Site
Fort Wayne, Indiana, 46825
Pfizer Investigational Site
Greenbelt, Maryland, 20770
Pfizer Investigational Site
Hamden, Connecticut, 06518
Pfizer Investigational Site
Henderson, Nevada, 89014
Pfizer Investigational Site
Hermosa Beach, California, 90254
Pfizer Investigational Site
Houston, Texas, 77024
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Jensen Beach, Florida, 34957
Pfizer Investigational Site
Jonesboro, Arkansas, 72401
Pfizer Investigational Site
Kalamazoo, Michigan, 49009
Pfizer Investigational Site
Leawood, Kansas, 66211
Pfizer Investigational Site
Marietta, Georgia, 30060
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
Metairie, Louisiana, 70002
Pfizer Investigational Site
Miami, Florida, 33186
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209
Pfizer Investigational Site
New Brunswick, New Jersey, 08903
Pfizer Investigational Site
New London, Connecticut, 06320
Pfizer Investigational Site
New Port Richey, Florida, 34652
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
Newburgh, Indiana, 47630
Pfizer Investigational Site
North Las Vegas, Nevada, 89030
Pfizer Investigational Site
Oakland, California, 94612
Pfizer Investigational Site
Palm Harbor, Florida, 34683
Pfizer Investigational Site
Pembroke Pines, Florida, 33028
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19106
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19148
Pfizer Investigational Site
Plantation, Florida, 33324
Pfizer Investigational Site
Poughkeepsie, New York, 12601
Pfizer Investigational Site
Providence, Rhode Island, 02904
Pfizer Investigational Site
Reading, Pennsylvania, 19606
Pfizer Investigational Site
Reading, Pennsylvania, 19607-1649
Pfizer Investigational Site
Renton, Washington, 98055
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Rochester, New York, 14609
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Diego, California, 92108
Pfizer Investigational Site
Sandy City, Utah, 84070
Pfizer Investigational Site
Santa Monica, California, 90404
Pfizer Investigational Site
Savannah, Georgia, 31405
Pfizer Investigational Site
Seattle, Washington, 98105
Pfizer Investigational Site
Seattle, Washington, 98115
Pfizer Investigational Site
Southfield, Michigan, 48034
Pfizer Investigational Site
St. Petersburg, Florida, 33710
Pfizer Investigational Site
Stuart, Florida, 34994
Pfizer Investigational Site
Stuart, Florida, 34996
Pfizer Investigational Site
Temple, Pennsylvania, 19560
Pfizer Investigational Site
Torrance, California, 90505
Pfizer Investigational Site
Tucson, Arizona, 85712
Pfizer Investigational Site
Tucson, Arizona, 85719
Pfizer Investigational Site
Waterbury, Connecticut, 06708
Pfizer Investigational Site
West Palm Beach, Florida, 33409
Pfizer Investigational Site
West Reading, Pennsylvania, 19611-1499
Pfizer Investigational Site
White Plains, New York, 10603
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

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.

Conditions: Sexual Dysfunctions, Psychological, Sexual Arousal Disorder
Being tested: sildenafil
Medical subject headings: Sexual Dysfunctions, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

sildenafilDrug
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

Study groups in NCT00746967
Study group	Role	What they receive
Arm 1	Other	Not described Receives: Drug: sildenafil

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety/toleration of oral sildenafil.
Measured: Continuous

Secondary outcomes (13)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2003Feb 2004

First posted4 Sep 2008 (estimated)
Study startJan 2003
Study completionFeb 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sexual Dysfunctions, PsychologicalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 267 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00746967
Sponsor's protocol ID: A1481133
Status last verified: Jan 2021
First submitted: 31 Mar 2008
Last updated: 1 Feb 2021
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
The PANHIS Study: Sexual Health in Spanish-Speaking Adults - A Cross-Sectional Online Survey
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Not yet recruitingPhase 1/2
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
Active, not recruitingPhase 4
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease
Peyronie Disease, Sexual Dysfunctions, Psychological
Active, not recruiting
Early Psychological Intervention After Rape
Post Traumatic Stress Disorder, Rape Sexual Assault
Active, not recruiting
Sexual Health and Rehabilitation Online (SHAREonline)
Cancer Survivorship, Sexual Function Disturbances

All Sexual Dysfunctions, Psychological trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00746967
Acronym / sponsor ID: A1481133
Conditions: Sexual Dysfunctions, Psychological, Sexual Arousal Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 267 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Jan 2003
Study completion: Feb 2004 (actual)
First posted: 4 Sep 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm 1	Other	Drug: sildenafil

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
sildenafilsildenafil 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	Drug	Arm 1

Primary outcome

Safety/toleration of oral sildenafil.
Time frame: Continuous

13 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Sexual Dysfunctions, Psychological

RecruitingObservational study
The PANHIS Study: Sexual Health in Spanish-Speaking Adults - A Cross-Sectional Online Survey
Sexual Health, Sexual Dysfunction, Physiological
Not yet recruitingPhase 1/2
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
Active, not recruitingPhase 4
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease
Peyronie Disease, Sexual Dysfunctions, Psychological
Active, not recruiting
Early Psychological Intervention After Rape
Post Traumatic Stress Disorder, Rape Sexual Assault
Active, not recruiting
Sexual Health and Rehabilitation Online (SHAREonline)
Cancer Survivorship, Sexual Function Disturbances

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

82 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety/toleration of oral sildenafil. (time frame: Continuous). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00746967.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021; AzTrials last refreshed its copy on 1 Nov 2026.