SAR407899 Single-dose in Treatment of Mild to Moderate Erectile Dysfunction
RHOKET
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).
2 other identifiers
interventional
24
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 2, 2009
CompletedFirst Posted
Study publicly available on registry
June 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedMay 2, 2011
April 1, 2011
4 months
June 2, 2009
April 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of penile rigidity during sexual stimulation
4 hours following drug administration
Secondary Outcomes (2)
Time to onset of penile rigidity
4 hours following drug administration
Blood pressure
12 hours following drug administration
Study Arms (4)
Sequence 1
EXPERIMENTALPeriod 1: placebo Period 2: sildenafil Period 3: SAR407899 dose level 2 Period 4: SAR407899 dose level 1
Sequence 2
EXPERIMENTALPeriod 1: sildenafil Period 2: SAR407899 dose level 1 Period 3: placebo Period 4: SAR407899 dose level 2
Sequence 3
EXPERIMENTALPeriod 1: SAR407899 dose level 1 Period 2: SAR407899 dose level 2 Period 3: sildenafil Period 4: placebo
Sequence 4
EXPERIMENTALPeriod 1: SAR407899 dose level 2 Period 2: placebo Period 3: SAR407899 dose level 1 Period 4: sildenafil
Interventions
Eligibility Criteria
You may qualify if:
- male with mild to moderate erectile dysfunction for at least 6 months
- written informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis Administrative Office
Paris, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lionel HOVSEPIAN, MD
SGS Aster Life Science Services - Paris-France
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 2, 2009
First Posted
June 4, 2009
Study Start
May 1, 2009
Primary Completion
September 1, 2009
Study Completion
October 1, 2009
Last Updated
May 2, 2011
Record last verified: 2011-04