Erectile DysfunctionPhase 4NCT00648596
A Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfuntion
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 66 sites in 8 countries.
Trial summary
To determine the improvement in the self-esteem domain score of the Self-Esteem/Overall Relationship (SEAR) questionnaire and the improvement in erectile function (obtained from the Erectile Function [EF] domain of the International Index of Erectile Function [IIEF]). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- 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
- 780 participants
- Where
- 66 sitesin 8 countries
- Study dates
- May 2003to May 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Men with a documented clinical diagnosis of ED confirmed by a Sexual Health Inventory-Male (SHI-M) score of 21 or less and who have a sexual partner for the duration of the study were included.
Who cannot join
- Subjects who have previously taken, or it is suspected they have taken, more than 4 doses of sildenafil citrate, or any other phosphodiesterase type 5 (PDE-5) inhibitor, or apomorphine, at any time prior to the screening visit or patients who have taken any dose of these compounds in the last two months
- Subjects with resting sitting hypotension (BP < 90/50mmHg) or hypertension (BP > 170/110mmHg)
- Subjects with significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischaemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias in the last 3 months
- Patients on nitrates.
Trial locations and contacts
66 sites in 8 countries.
66 sites in 8 countries
Russia17 sites
Pfizer Investigational Site
Barnaul, 656099
Pfizer Investigational Site
Moscow, 105425
Pfizer Investigational Site
Moscow, 117036
Pfizer Investigational Site
Moscow, 121552
Pfizer Investigational Site
Moscow, 123448
Pfizer Investigational Site
Moscow, 125101
Pfizer Investigational Site
Moscow, 125206
Pfizer Investigational Site
Moscow, 127411
Pfizer Investigational Site
Moscow
Pfizer Investigational Site
Nizhny Novgorod
Pfizer Investigational Site
Novosibirsk, 630003
Pfizer Investigational Site
Novosibirsk, 630087
Pfizer Investigational Site
Rostov-on-Don, 344068
Pfizer Investigational Site
Saint Petersburg, 193318
Pfizer Investigational Site
Saint Petersburg, 197089
Pfizer Investigational Site
Saint Petersburg
Pfizer Investigational Site
Yekaterinburg
Spain9 sites
Pfizer Investigational Site
Barakaldo, Vizcaya, 48903
Pfizer Investigational Site
Barcelona, 08036
Pfizer Investigational Site
Madrid, 28007
Pfizer Investigational Site
Madrid, 28041
Pfizer Investigational Site
Madrid, 28046
Pfizer Investigational Site
San Juan, Alicante, 03550
Pfizer Investigational Site
Valencia, 46009
Pfizer Investigational Site
Valencia, 46010
Pfizer Investigational Site
Zaragoza, 50009
United Kingdom9 sites
Pfizer Investigational Site
Addlestone, Surrey, KT15 2BH
Pfizer Investigational Site
Ashford, Middlesex, TW15 3EA
Pfizer Investigational Site
Belmont, Durham, DH1 2QP
Pfizer Investigational Site
Blackpool, Lancashire, FY4 3AD
Pfizer Investigational Site
Bodelwyddan, Denbighshire, LL18 5UJ
Pfizer Investigational Site
Nr Lichfield, Staffordshire, WS14 9JL
Pfizer Investigational Site
South Yorkshire, DN1 2ET
Pfizer Investigational Site
Taunton, TA1 5DA
Pfizer Investigational Site
Urmston, Manchester, M41 0UH
France8 sites
Pfizer Investigational Site
Clermont-Ferrand, 63023
Pfizer Investigational Site
LE Kremlin Bicentre, 94275
Pfizer Investigational Site
Lyon, 69437
Pfizer Investigational Site
Marseille, 13915
Pfizer Investigational Site
Neuilly-sur-Seine, 92200
Pfizer Investigational Site
Nice, 06002
Pfizer Investigational Site
Nîmes, 30029
Pfizer Investigational Site
Toulouse, 31403
Italy8 sites
Pfizer Investigational Site
Bari, 70124
Pfizer Investigational Site
Catania, 95124
Pfizer Investigational Site
Gallarate (VA), 21013
Pfizer Investigational Site
Modena, 41100
Pfizer Investigational Site
Padova, 35128
Pfizer Investigational Site
Roma, 00100
Pfizer Investigational Site
Siena, 53100
Pfizer Investigational Site
Torino, 10126
Poland6 sites
Pfizer Investigational Site
Krakow
Pfizer Investigational Site
Lodz
Pfizer Investigational Site
Lublin
Pfizer Investigational Site
Olsztyn
Pfizer Investigational Site
Szczecin
Pfizer Investigational Site
Warsaw
Sweden6 sites
Pfizer Investigational Site
Karlshamn, 374 35
Pfizer Investigational Site
Malmö, 205 02
Pfizer Investigational Site
Skövde, 541 30
Pfizer Investigational Site
Stockholm, 171 76
Pfizer Investigational Site
Värnamo, 331 85
Pfizer Investigational Site
Västervik, 593 81
Finland3 sites
Pfizer Investigational Site
Oulu, 90100
Pfizer Investigational Site
Tampere
Pfizer Investigational Site
Turku, 20110
About this study
Official title: An International, Multicentre, Randomized, Parallel Group, Double Blind, Placebo Controlled, Flexible Dose Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfunction Treated With Sildenafil Citrate
To determine the improvement in the self-esteem domain score of the Self-Esteem/Overall Relationship (SEAR) questionnaire and the improvement in erectile function (obtained from the Erectile Function [EF] domain of the International Index of Erectile Function [IIEF]). Furthermore, to determine if the improvement obtained in self-esteem was related to the main erectile dysfunction (ED) co-morbidities type and/or number.
- 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 tablet by mouth 1 hour before sexual activity for 12 weeks; the dose could be increased to 100 mg or decreased to 25 mg.
placeboDrug
placebo tablet by mouth 1 hour before sexual activity for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 | Placebo comparator | Not described Receives: Drug: placebo |
| Arm 1 | Active comparator | Not described Receives: Drug: sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Self-esteem domain of the SEAR questionnaire
Measured: Week 12
Secondary outcomes (14)
Correlation between the change in the SE domain of the SEAR questionnaire and the erectile function domain of the IIEF by number of ED co-morbidities
Measured: Week 12
Differences in the global efficacy assessment question overall and by type of co-morbidity
Measured: Week 12
Differences in the global satisfaction assessment questions overall and by type of co-morbidity
Measured: Week 12
Comparisons between treatments in the SE domain of the SEAR questionnaire by type of co-morbidity (hypertension, hyperlipidemia, diabetes mellitus, benign prostatic hyperplasia, depression)
Measured: Week 12
Changes in the sexual activity domain of the SEAR questionnaire overall and by type of co-morbidity
Measured: Week 12
Changes in the relationship domain of the SEAR questionnaire overall and by type of co-morbidity
Measured: Week 12
Changes of the SEAR questions overall and by type of co-morbidity
Measured: Week 12
Changes of the IIEF questions overall and by type of co-morbidity
Measured: Week 12
Changes of the IIEF domains overall and by type of co-morbidity
Measured: Week 12
Degrees of severity in the IIEF erectile function
Measured: Week 12
Correlation between the change in the SE domain of the SEAR questionnaire and the erectile function domain of the IIEF overall and by type of co-morbidity
Measured: Week 12
Changes in the questions from the event log overall and by type of co-morbidity
Measured: Week 12
Correlation between each success rate derived from the event log and the change in the SE domain of the SEAR questionnaire overall and by type of co-morbidity
Measured: Week 12
Differences in the intercourse success rates derived from the event log overall and by type of comorbidity
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 posted1 Apr 2008 (estimated)
- Study startMay 2003
- Study completionMay 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
- 780 participants (actual)
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
- NCT00648596
- Sponsor's protocol ID
- A1481161
- Status last verified
- Jan 2021
- First submitted
- 27 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
- An International, Multicentre, Randomized, Parallel Group, Double Blind, Placebo Controlled, Flexible Dose Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfunction Treated With Sildenafil Citrate
- ClinicalTrials.gov ID
- NCT00648596
- Acronym / sponsor ID
- A1481161
- Conditions
- Erectile Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- May 2003
- Study completion
- May 2004 (actual)
- First posted
- 1 Apr 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 determine the improvement in the self-esteem domain score of the Self-Esteem/Overall Relationship (SEAR) questionnaire and the improvement in erectile function (obtained from the Erectile Function [EF] domain of the International Index of Erectile Function [IIEF]). Furthermore, to determine if the improvement obtained in self-esteem was related to the main erectile dysfunction (ED) co-morbidities type and/or number.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 2 | Placebo comparator | Drug: placebo |
| Arm 1 | Active comparator | Drug: sildenafil |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Men with a documented clinical diagnosis of ED confirmed by a Sexual Health Inventory-Male (SHI-M) score of 21 or less and who have a sexual partner for the duration of the study were included.
Key exclusion criteria (4 listed)
- Subjects who have previously taken, or it is suspected they have taken, more than 4 doses of sildenafil citrate, or any other phosphodiesterase type 5 (PDE-5) inhibitor, or apomorphine, at any time prior to the screening visit or patients who have taken any dose of these compounds in the last two months
- Subjects with resting sitting hypotension (BP < 90/50mmHg) or hypertension (BP > 170/110mmHg)
- Subjects with significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischaemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias in the last 3 months
- Patients on nitrates.
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 tablet by mouth 1 hour before sexual activity for 12 weeks; the dose could be increased to 100 mg or decreased to 25 mg. | Drug | Arm 1 |
| placeboplacebo tablet by mouth 1 hour before sexual activity for 12 weeks | Drug | Arm 2 |
Primary outcome
Change from baseline in the Self-esteem domain of the SEAR questionnaire
Time frame: Week 12
14 secondary outcomes
Correlation between the change in the SE domain of the SEAR questionnaire and the erectile function domain of the IIEF by number of ED co-morbidities
Time frame: Week 12
Differences in the global efficacy assessment question overall and by type of co-morbidity
Time frame: Week 12
Differences in the global satisfaction assessment questions overall and by type of co-morbidity
Time frame: Week 12
Comparisons between treatments in the SE domain of the SEAR questionnaire by type of co-morbidity (hypertension, hyperlipidemia, diabetes mellitus, benign prostatic hyperplasia, depression)
Time frame: Week 12
Changes in the sexual activity domain of the SEAR questionnaire overall and by type of co-morbidity
Time frame: Week 12
Changes in the relationship domain of the SEAR questionnaire overall and by type of co-morbidity
Time frame: Week 12
Changes of the SEAR questions overall and by type of co-morbidity
Time frame: Week 12
Changes of the IIEF questions overall and by type of co-morbidity
Time frame: Week 12
Changes of the IIEF domains overall and by type of co-morbidity
Time frame: Week 12
Degrees of severity in the IIEF erectile function
Time frame: Week 12
Correlation between the change in the SE domain of the SEAR questionnaire and the erectile function domain of the IIEF overall and by type of co-morbidity
Time frame: Week 12
Changes in the questions from the event log overall and by type of co-morbidity
Time frame: Week 12
Correlation between each success rate derived from the event log and the change in the SE domain of the SEAR questionnaire overall and by type of co-morbidity
Time frame: Week 12
Differences in the intercourse success rates derived from the event log overall and by type of comorbidity
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
66 sites in 8 countries: 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 66 sites in 8 countries.
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 1 inclusion and 4 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 66 sites in Russia, Spain, United Kingdom, France, Italy and 3 more countries. 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?
Change from baseline in the Self-esteem domain of the SEAR questionnaire (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.