Erectile DysfunctionPhase 4PDE5iNCT01364701
Evaluation of Safety and Effectiveness of 2 Lower Dose Combined PDE5i's Versus Single Maximal Dose PDE5i Treatment
A Phase 4 study testing Sildenafil 100 mg, Tadalafil 20 mg and Combination half of maximal dose for sildenafil & tadalafil in people with Erectile Dysfunction, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Clinical effectiveness is of the finest tools to evaluate treatment success and is combined of 3 elements: treatment effectivity, side effect profile and patient compliance. Since the 3 main PDE5i's differ in their molecular structure, therapeutic profile and pharmacokinetics, it seems logical to assume that combining… Read more about this study
- Who is it for?
- Ages 35 to 75 years, women only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Sildenafil 100 mg, Tadalafil 20 mg and Combination half of maximal dose for sildenafil & tadalafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2011to Jul 2012
- 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 35 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ranging between 35-75 years.
- Sexually active
- IIEF ED domain score 22 and below
Who cannot join
- Subjects with premature ejaculation as their main sexual complaint.
- Subjects with severe cardiovascular disease
- Subjects with Contraindications to PDE5i therapy. Namely patients receiving treatment with nitrate based medication or patients that for various reasons cannot take PDE5 inhibitors (i.e severe coronary disease, liver or renal failure, concomitant medications, etc.).
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rambam Health Care Campus
Haifa
Ilan Gruenwald, MD, 0097248542882, i_gruenwald@rambam.health.gov.il
About this study
Official title: A Prospective, Randomized, 3-arm Parallel Trial to Evaluate the Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i Treatment
Clinical effectiveness is of the finest tools to evaluate treatment success and is combined of 3 elements: treatment effectivity, side effect profile and patient compliance. Since the 3 main PDE5i's differ in their molecular structure, therapeutic profile and pharmacokinetics, it seems logical to assume that combining 2 different PDE5i's at lower dosage each may be beneficial in comparison to a single PDE5i maximal dose therapy. The aim of this study is to compare the clinical effectiveness of combination therapy (2 lower-dose PDE5i's) versus single maximal dose PDE5i therapy.
Read the detailed description
This will be a prospective, randomized, 3-arm parallel trial on 60 males with erectile dysfunction (ED) that have never been exposed to PDE5i therapy (naïve patients) will be enrolled. In each group, every patient will receive three treatment regimes (Viagra®50mg \& Cialis®10mg, Viagra®100mg, Cialis®20mg), in different sequences of administration.
- Conditions
- Erectile Dysfunction
- Being tested
- Sildenafil 100 mg, Tadalafil 20 mg, Combination half of maximal dose for sildenafil & tadalafil
- Keywords
- Erectile dysfunction, combination therapy, Sildenafil, tadalafil, PDE5i, No Conditions
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil 100 mgDrug
Also called Viagra
4 tablets for on demand use
Tadalafil 20 mgDrug
Also called Cialis
4 tablets on demand
Combination half of maximal dose for sildenafil & tadalafilDrug
Also called Combination
4 tablets on demand
| Study group | Role | What they receive |
|---|---|---|
| Maximal dose sildenafil | Active comparator | 4 tablets of sildenafil 100mg are given for on demand use Receives: Drug: Sildenafil 100 mg |
| Tadalafil 20mg maximal dose | Active comparator | 4 tablets of tadalafil 20mg are given for on demand use Receives: Drug: Tadalafil 20 mg |
| Combination half dose | Active comparator | 4 tablets of sildenafil 50mg and tadalafil 10mg are given for on demand use Receives: Drug: Combination half of maximal dose for sildenafil & tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function-Erectile Dysfunction (IIEF-ED) Domain Score
At each visit after use of different treatment each time
Measured: Every visit- altogether 3 months
Secondary outcomes (1)
Erection Hardness Scale
At each visit after use of different treatment each time
Measured: Each visit- altogether 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012 (estimated)
- Study completionJul 2012 (estimated)
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Yoram Vardi, Prof., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364701
- Sponsor's protocol ID
- 0449-10-RMB
- Acronym
- PDE5i
- Status last verified
- Apr 2011
- First submitted
- 18 May 2011
- Last updated
- 20 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, 3-arm Parallel Trial to Evaluate the Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i Treatment
- ClinicalTrials.gov ID
- NCT01364701
- Acronym / sponsor ID
- PDE5i / 0449-10-RMB
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile dysfunction, combination therapy, Sildenafil, tadalafil, PDE5i, No Conditions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 2 Jun 2011 (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.
Clinical effectiveness is of the finest tools to evaluate treatment success and is combined of 3 elements: treatment effectivity, side effect profile and patient compliance. Since the 3 main PDE5i's differ in their molecular structure, therapeutic profile and pharmacokinetics, it seems logical to assume that combining 2 different PDE5i's at lower dosage each may be beneficial in comparison to a single PDE5i maximal dose therapy. The aim of this study is to compare the clinical effectiveness of combination therapy (2 lower-dose PDE5i's) versus single maximal dose PDE5i therapy.
Detailed description
This will be a prospective, randomized, 3-arm parallel trial on 60 males with erectile dysfunction (ED) that have never been exposed to PDE5i therapy (naïve patients) will be enrolled. In each group, every patient will receive three treatment regimes (Viagra®50mg \& Cialis®10mg, Viagra®100mg, Cialis®20mg), in different sequences of administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Maximal dose sildenafil | Active comparator | Drug: Sildenafil 100 mg4 tablets of sildenafil 100mg are given for on demand use |
| Tadalafil 20mg maximal dose | Active comparator | Drug: Tadalafil 20 mg4 tablets of tadalafil 20mg are given for on demand use |
| Combination half dose | Active comparator | Drug: Combination half of maximal dose for sildenafil & tadalafil4 tablets of sildenafil 50mg and tadalafil 10mg are given for on demand use |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ranging between 35-75 years.
- Sexually active
- IIEF ED domain score 22 and below
Key exclusion criteria (3 listed)
- Subjects with premature ejaculation as their main sexual complaint.
- Subjects with severe cardiovascular disease
- Subjects with Contraindications to PDE5i therapy. Namely patients receiving treatment with nitrate based medication or patients that for various reasons cannot take PDE5 inhibitors (i.e severe coronary disease, liver or renal failure, concomitant medications, etc.).
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 |
|---|---|---|
| Sildenafil 100 mgAlso: Viagra4 tablets for on demand use | Drug | Maximal dose sildenafil |
| Tadalafil 20 mgAlso: Cialis4 tablets on demand | Drug | Tadalafil 20mg maximal dose |
| Combination half of maximal dose for sildenafil & tadalafilAlso: Combination4 tablets on demand | Drug | Combination half dose |
Primary outcome
International Index of Erectile Function-Erectile Dysfunction (IIEF-ED) Domain Score
Time frame: Every visit- altogether 3 months
At each visit after use of different treatment each time
1 secondary outcome
Erection Hardness Scale
Time frame: Each visit- altogether 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2011.
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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.
Yoram Vardi, Prof. principal investigator
Rambam Health Care Campus
1 site 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 100 mg, Tadalafil 20 mg and Combination half of maximal dose for sildenafil & tadalafil in people with Erectile Dysfunction, run by Rambam Health Care Campus at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 20 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilan Gruenwald, MD (0097248542882, i_gruenwald@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Index of Erectile Function-Erectile Dysfunction (IIEF-ED) Domain Score (time frame: Every visit- altogether 3 months). 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 20 Jun 2011.