Erectile DysfunctionPhase 4NCT00644631
A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled, Flexible Dose Escalation Study To Evaluate Sexual And Relationship Satisfaction In The Female Partner Of Men With Erectile Dysfunction Treated With Sildenafil Citrate
A Phase 4 study testing sildenafil in people with Erectile Dysfunction, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 31 sites in United States.
Trial summary
To compare the effects of sildenafil versus placebo on the female partner's sexual satisfaction as assessed by Question 3 of Female Partner of Erectile Dysfunction (ED) Subject Questionnaire (FePEDS-Q): "Over the past 4 weeks, when you had sexual intercourse, how often was it satisfactory for you?" For ED subjects… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 31 sitesUnited States
- Study dates
- Jun 2003to Apr 2004
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The male patient must have had a documented clinical diagnosis of erectile dysfunction (ED) confirmed by a Sexual Health Inventory-Male (SHI-M) score of less than or equal to 21
- a stable female partner at least 21 years of age for at least 6 months prior to screening
- the couple must have been married or living together at the time of screening.
- The female partner must have answered "no intercourse," "sometimes," "a few times" or "almost never" on Question 3 of the Female Partner of ED Subject Questionnaire (FePEDS-Q)
Who cannot join
- The male patient must not have had resting sitting and/or standing hypotension (BP < 90/50mmHg) or hypertension (BP > 170/110mmHg), or significant cardiovascular disease in the last 3 months, including cardiac failure, myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias.
- Female partners must not have had significant dyspareunia or lifelong significant sexual dysfunction based on female partner's medical and sexual history at screening.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Pfizer Investigational Site
Aurora, Colorado, 80012
Pfizer Investigational Site
Baltimore, Maryland, 21204
Pfizer Investigational Site
Beachwood, Ohio, 44122-5402
Pfizer Investigational Site
Beverly Hills, California, 90212
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Des Moines, Iowa, 50314
Pfizer Investigational Site
Durham, North Carolina, 27705
Pfizer Investigational Site
Garden City, New York, 11530
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Jeffersonville, Indiana, 47130
Pfizer Investigational Site
Knoxville, Tennessee, 37920
Pfizer Investigational Site
Lacey, Washington, 98516
Pfizer Investigational Site
Laguna Woods, California, 92653
Pfizer Investigational Site
Little Rock, Arkansas
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Los Angeles, California, 90073
Pfizer Investigational Site
New York, New York, 10016
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Newtown, Pennsylvania, 18940
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Overland Park, Kansas, 66215
Pfizer Investigational Site
Palo Alto, California, 94305
Pfizer Investigational Site
Peabody, Massachusetts, 01960
Pfizer Investigational Site
Peoria, Illinois, 61614
Pfizer Investigational Site
Poughkeepsie, New York, 12601
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Seattle, Washington, 98105
Pfizer Investigational Site
Spokane, Washington, 99207
Pfizer Investigational Site
St Louis, Missouri, 63117
Pfizer Investigational Site
Torrance, California, 90505
Pfizer Investigational Site
Waterbury, Connecticut, 06708
About this study
Official title: A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled, Flexible Dose Escalation Study To Evaluate Sexual And Relationship Satisfaction In The Female Partner Of Men With Erectile Dysfunction Treated With Viagra (Sildenafil Citrate) In The United States
To compare the effects of sildenafil versus placebo on the female partner's sexual satisfaction as assessed by Question 3 of Female Partner of Erectile Dysfunction (ED) Subject Questionnaire (FePEDS-Q): "Over the past 4 weeks, when you had sexual intercourse, how often was it satisfactory for you?" For ED subjects, determine difference in the Erectile Function domain of International Index of Erectile Function (IIEF) between sildenafil citrate and placebo at end of the treatment phase and determine the overall relationship between improved erectile function and increased ED subject and female partner satisfaction.
- Conditions
- Erectile Dysfunction
- Being tested
- sildenafil, placebo
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafilDrug
sildenafil 50 mg (initial dose) tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks; depending upon safety, efficacy and tolerability, the dose could be increased to 100 mg or reduced to 25 mg, if necessary.
placeboDrug
placebo tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: sildenafil |
| Arm 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Question 3 of the Female Partner ED Subject Questionnaire (FePEDS-Q) in female partners.
Measured: Week 12
Secondary outcomes (16)
International Index of Erectile Function (IIEF) Erectile Function, Desire, Orgasm, Intercourse Satisfaction, and Overall Satisfaction Domains in ED patients
Measured: Week 8 and Week 12
Self-Esteem and Relationship Questionnaire (SEAR) in ED patients
Measured: Week 12
ED Subject Event Log in ED patients
Measured: Week 12
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index of treatment satisfaction in ED patients
Measured: Week 12
Dyadic Adjustment Scale (DAS) in ED patients
Measured: Week 8 and Week 12
American Urological Association (AUA) Symptom Index in ED patients
Measured: Week 12
Global Efficacy Assessment Questions (GEQ) in ED patients
Measured: Week 12
Questions 1 and 2 of Female Partner of ED Subject Questionnaire (FePEDS-Q) in female partners
Measured: Week 8 and Week 12
Sexual Function Questionnaire (SFQ) Desire, Arousal, Enjoyment and Orgasm Domains in female partners
Measured: Week 12
Female Sexual Function Inventory (FSFI) Desire, Satisfaction and Arousal Domains in female partners
Measured: Week 12
Partner EDITS in female partners
Measured: Week 12
Female Partner Treatment Continuation Question in female partners
Measured: Week 12
Dyadic Adjustment Scale (DAS) in female partners
Measured: Week 8 and Week 12
Beck Depression Inventory (BDI-II) in female partners
Measured: Week 12
Female Partner Event Log in female partners
Measured: Week 12
AUA Symptom Index in female partners
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startJun 2003
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644631
- Sponsor's protocol ID
- A1481177
- Status last verified
- Jan 2021
- First submitted
- 25 Mar 2008
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
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
- A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled, Flexible Dose Escalation Study To Evaluate Sexual And Relationship Satisfaction In The Female Partner Of Men With Erectile Dysfunction Treated With Viagra (Sildenafil Citrate) In The United States
- ClinicalTrials.gov ID
- NCT00644631
- Acronym / sponsor ID
- A1481177
- Conditions
- Erectile Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Apr 2004 (actual)
- First posted
- 27 Mar 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.
To compare the effects of sildenafil versus placebo on the female partner's sexual satisfaction as assessed by Question 3 of Female Partner of Erectile Dysfunction (ED) Subject Questionnaire (FePEDS-Q): "Over the past 4 weeks, when you had sexual intercourse, how often was it satisfactory for you?" For ED subjects, determine difference in the Erectile Function domain of International Index of Erectile Function (IIEF) between sildenafil citrate and placebo at end of the treatment phase and determine the overall relationship between improved erectile function and increased ED subject and female partner satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: sildenafil |
| Arm 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The male patient must have had a documented clinical diagnosis of erectile dysfunction (ED) confirmed by a Sexual Health Inventory-Male (SHI-M) score of less than or equal to 21
- a stable female partner at least 21 years of age for at least 6 months prior to screening
- the couple must have been married or living together at the time of screening.
- The female partner must have answered "no intercourse," "sometimes," "a few times" or "almost never" on Question 3 of the Female Partner of ED Subject Questionnaire (FePEDS-Q)
Key exclusion criteria (2 listed)
- The male patient must not have had resting sitting and/or standing hypotension (BP < 90/50mmHg) or hypertension (BP > 170/110mmHg), or significant cardiovascular disease in the last 3 months, including cardiac failure, myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias.
- Female partners must not have had significant dyspareunia or lifelong significant sexual dysfunction based on female partner's medical and sexual history at screening.
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 (initial dose) tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks; depending upon safety, efficacy and tolerability, the dose could be increased to 100 mg or reduced to 25 mg, if necessary. | Drug | Arm 1 |
| placeboplacebo tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks | Drug | Arm 2 |
Primary outcome
Question 3 of the Female Partner ED Subject Questionnaire (FePEDS-Q) in female partners.
Time frame: Week 12
16 secondary outcomes
International Index of Erectile Function (IIEF) Erectile Function, Desire, Orgasm, Intercourse Satisfaction, and Overall Satisfaction Domains in ED patients
Time frame: Week 8 and Week 12
Self-Esteem and Relationship Questionnaire (SEAR) in ED patients
Time frame: Week 12
ED Subject Event Log in ED patients
Time frame: Week 12
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index of treatment satisfaction in ED patients
Time frame: Week 12
Dyadic Adjustment Scale (DAS) in ED patients
Time frame: Week 8 and Week 12
American Urological Association (AUA) Symptom Index in ED patients
Time frame: Week 12
Global Efficacy Assessment Questions (GEQ) in ED patients
Time frame: Week 12
Questions 1 and 2 of Female Partner of ED Subject Questionnaire (FePEDS-Q) in female partners
Time frame: Week 8 and Week 12
Sexual Function Questionnaire (SFQ) Desire, Arousal, Enjoyment and Orgasm Domains in female partners
Time frame: Week 12
Female Sexual Function Inventory (FSFI) Desire, Satisfaction and Arousal Domains in female partners
Time frame: Week 12
Partner EDITS in female partners
Time frame: Week 12
Female Partner Treatment Continuation Question in female partners
Time frame: Week 12
Dyadic Adjustment Scale (DAS) in female partners
Time frame: Week 8 and Week 12
Beck Depression Inventory (BDI-II) in female partners
Time frame: Week 12
Female Partner Event Log in female partners
Time frame: Week 12
AUA Symptom Index in female partners
Time frame: Week 12
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.
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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
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sildenafil in people with Erectile Dysfunction, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 31 sites in United States.
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 4 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 31 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Question 3 of the Female Partner ED Subject Questionnaire (FePEDS-Q) in female partners. (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.