Erectile DysfunctionPhase 2RHOKETNCT00914277
SAR407899 Single-dose in Treatment of Mild to Moderate Erectile Dysfunction
A Phase 2 study testing SAR407899 and Sildenafil in people with Erectile Dysfunction, run by Sanofi at 1 site in France.
Trial summary
The primary objective of this clinical trial is to study the ability of SAR407899 to increase the duration of penile erection in male patients with mild-moderate Erectile Dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- SAR407899 and Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- May 2009to Oct 2009
- 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 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- male with mild to moderate erectile dysfunction for at least 6 months
- written informed consent
Who cannot join
- diabetes mellitus
- orthostatic hypotension
- hypogonadal testosterone level
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo and Active Controlled Study of the Activity of SAR407899A Single-dose on the Ability to Increase Duration of Penile Rigidity, Under Experimental Condition, in Patients With Mild to Moderate Erectile Dysfunction (ED).
The primary objective of this clinical trial is to study the ability of SAR407899 to increase the duration of penile erection in male patients with mild-moderate Erectile Dysfunction.
The secondary objectives of this clinical trial are to study the ability of SAR407899 to shorten increase the time to erection duration of penile erection in male patients with mild-moderate Erectile Dysfunction and to determine the overall safety and tolerability of SAR407899 in these patients.
- Conditions
- Erectile Dysfunction
- Being tested
- SAR407899, Placebo, Sildenafil
- Keywords
- Rho-kinase inhibitor, male impotence
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR407899Drug
Oral administration
PlaceboDrug
Oral administration
SildenafilDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Period 1: placebo
Period 2: sildenafil
Period 3: SAR407899 dose level 2
Period 4: SAR407899 dose level 1 Receives: Drug: SAR407899; Drug: Placebo; Drug: Sildenafil |
| Sequence 2 | Experimental | Period 1: sildenafil
Period 2: SAR407899 dose level 1
Period 3: placebo
Period 4: SAR407899 dose level 2 Receives: Drug: SAR407899; Drug: Placebo; Drug: Sildenafil |
| Sequence 3 | Experimental | Period 1: SAR407899 dose level 1
Period 2: SAR407899 dose level 2
Period 3: sildenafil
Period 4: placebo Receives: Drug: SAR407899; Drug: Placebo; Drug: Sildenafil |
| Sequence 4 | Experimental | Period 1: SAR407899 dose level 2
Period 2: placebo
Period 3: SAR407899 dose level 1
Period 4: sildenafil Receives: Drug: SAR407899; Drug: Placebo; Drug: Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of penile rigidity during sexual stimulation
Measured: 4 hours following drug administration
Secondary outcomes (2)
Time to onset of penile rigidity
Measured: 4 hours following drug administration
Blood pressure
Measured: 12 hours following drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2009
- Study completionOct 2009
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.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lionel HOVSEPIAN, MD, Principal investigator, SGS Aster Life Science Services - Paris-France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914277
- Sponsor's protocol ID
- ACT10775
- Other IDs
- EudraCT:2009-009936-56
- Acronym
- RHOKET
- Status last verified
- Apr 2011
- First submitted
- 2 Jun 2009
- Last updated
- 2 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo and Active Controlled Study of the Activity of SAR407899A Single-dose on the Ability to Increase Duration of Penile Rigidity, Under Experimental Condition, in Patients With Mild to Moderate Erectile Dysfunction (ED).
- ClinicalTrials.gov ID
- NCT00914277
- Acronym / sponsor ID
- RHOKET / ACT10775
- Conditions
- Erectile Dysfunction
- Keywords
- Rho-kinase inhibitor, male impotence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 4 Jun 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.
The primary objective of this clinical trial is to study the ability of SAR407899 to increase the duration of penile erection in male patients with mild-moderate Erectile Dysfunction.
The secondary objectives of this clinical trial are to study the ability of SAR407899 to shorten increase the time to erection duration of penile erection in male patients with mild-moderate Erectile Dysfunction and to determine the overall safety and tolerability of SAR407899 in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: SAR407899, Drug: Placebo, Drug: SildenafilPeriod 1: placebo Period 2: sildenafil Period 3: SAR407899 dose level 2 Period 4: SAR407899 dose level 1 |
| Sequence 2 | Experimental | Drug: SAR407899, Drug: Placebo, Drug: SildenafilPeriod 1: sildenafil Period 2: SAR407899 dose level 1 Period 3: placebo Period 4: SAR407899 dose level 2 |
| Sequence 3 | Experimental | Drug: SAR407899, Drug: Placebo, Drug: SildenafilPeriod 1: SAR407899 dose level 1 Period 2: SAR407899 dose level 2 Period 3: sildenafil Period 4: placebo |
| Sequence 4 | Experimental | Drug: SAR407899, Drug: Placebo, Drug: SildenafilPeriod 1: SAR407899 dose level 2 Period 2: placebo Period 3: SAR407899 dose level 1 Period 4: sildenafil |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male with mild to moderate erectile dysfunction for at least 6 months
- written informed consent
Key exclusion criteria (4 listed)
- diabetes mellitus
- orthostatic hypotension
- hypogonadal testosterone level
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| SAR407899Oral administration | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| PlaceboOral administration | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| SildenafilOral administration | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
Duration of penile rigidity during sexual stimulation
Time frame: 4 hours following drug administration
2 secondary outcomes
Time to onset of penile rigidity
Time frame: 4 hours following drug administration
Blood pressure
Time frame: 12 hours following drug administration
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 2 May 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.
Lionel HOVSEPIAN, MD principal investigator
SGS Aster Life Science Services - Paris-France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAR407899 and Sildenafil in people with Erectile Dysfunction, run by Sanofi at 1 site in France.
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 2 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 2 May 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 France. 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?
Duration of penile rigidity during sexual stimulation (time frame: 4 hours following drug administration). 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 2 May 2011.