Erectile DysfunctionPhase 3STEDNCT00947323
Simvastatin for Treating Erectile Dysfunction
A Phase 3 study testing Simvastatin in people with Erectile Dysfunction and Vascular Disease Detected, run by Santa Casa de Porto Alegre.
Trial summary
This is a randomized clinical trial, double-blind, placebo controlled, to verify if simvastatin can improve erectile dysfunction in men with endothelial dysfunction, without any cardiac disease.It is hypothesized that the simvastatin can improve the endothelial function, improving the nitric oxide liberation in… Read more about this study
- Who is it for?
- Ages 35 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction, Vascular Disease Detected, C Reactive Protein
- What is being tested?
- Simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Dec 2008
- Phase
- Phase 3
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Erectile dysfunction
- Elevated C reactive protein
- Able to adhere the protocol
Who cannot join
- Diabetes mellitus
- Cardiac disease
- Cerebral vascular disease
- Hypogonadism
- Any contraindication to simvastatin
About this study
Official title: The Effect of Simvastatin in the Penile Erection: a Randomized, Double-blind Clinical Trial
This is a randomized clinical trial, double-blind, placebo controlled, to verify if simvastatin can improve erectile dysfunction in men with endothelial dysfunction, without any cardiac disease.It is hypothesized that the simvastatin can improve the endothelial function, improving the nitric oxide liberation in corpora cavernosa of the penis, resulting in improvement of erection.
- Being tested
- Simvastatin, Placebo
- Keywords
- simvastatin, endothelial dysfunction, erectile dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
simvastatin 20 daily for six months.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Simvastatin | Experimental | Treatment arm. Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penile erection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startJan 2006
- Primary completionJul 2008
- Study completionDec 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Casa de Porto Alegre
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947323
- Sponsor's protocol ID
- STED
- Acronym
- STED
- Status last verified
- Sep 2010
- First submitted
- 27 Jul 2009
- Last updated
- 27 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simvastatin in the Penile Erection: a Randomized, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT00947323
- Acronym / sponsor ID
- STED / STED
- Keywords
- simvastatin, endothelial dysfunction, erectile dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Santa Casa de Porto AlegreUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Jul 2009 (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.
This is a randomized clinical trial, double-blind, placebo controlled, to verify if simvastatin can improve erectile dysfunction in men with endothelial dysfunction, without any cardiac disease.It is hypothesized that the simvastatin can improve the endothelial function, improving the nitric oxide liberation in corpora cavernosa of the penis, resulting in improvement of erection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebo |
| Simvastatin | Experimental | Drug: SimvastatinTreatment arm. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Erectile dysfunction
- Elevated C reactive protein
- Able to adhere the protocol
Key exclusion criteria (5 listed)
- Diabetes mellitus
- Cardiac disease
- Cerebral vascular disease
- Hypogonadism
- Any contraindication to simvastatin
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 |
|---|---|---|
| Simvastatinsimvastatin 20 daily for six months. | Drug | Simvastatin |
| Placebo | Drug | placebo |
Primary outcome
Penile erection
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 27 Sep 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Simvastatin in people with Erectile Dysfunction and Vascular Disease Detected, run by Santa Casa de Porto Alegre.
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 5 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 27 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Penile erection. 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 27 Sep 2010.