Efficacy Study of RX-10100 to Treat Erectile Dysfunction (ED)
A Double-Blinded, Randomized, Placebo-Controlled, Dose-Exploring Study of RX-10100 for Eight Weeks of On-Demand Administration in Subjects With Erectile Dysfunction (ED)
1 other identifier
interventional
40
1 country
3
Brief Summary
The primary objective of this Phase IIa trial is to determine the effective doses and treatment period for an upcoming RX-10100 Phase IIb trial in subjects with erectile dysfunction (ED). The secondary objectives of this trial are to evaluate the safety and the quality of life in subjects with ED receiving RX-10100 treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2008
Shorter than P25 for phase_2
3 active sites
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
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 4, 2008
CompletedFirst Posted
Study publicly available on registry
June 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedMay 5, 2009
May 1, 2009
9 months
June 4, 2008
May 4, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Scores on IIEF-EF Questionnaires and on SEP Questions II and III
Weeks 4 and 8
Secondary Outcomes (1)
Scores on other domains of IIEF, other questions on Subject Diaries, RigiScan measurement, and ED-QoL questionnaires
Weeks 4 and 8
Study Arms (4)
1
PLACEBO COMPARATOR2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Have had ED for at least six months
- Stable, heterosexual relationship for at least 3 months
- Make at least one attempt of sexual intercourse per week during the untreated, 2-week screening period
- At least 50% of attempts of sexual intercourse during the untreated baseline period must be unsuccessful
- 'Moderate' or 'mild to moderate' ED, defined as an IIEF-EF domain score between 11 and 21 measured
You may not qualify if:
- Following previous or current medical conditions
- Any unstable medical, psychiatric, or substance abuse disorder
- Penile anatomical abnormalities
- Primary hypoactive sexual desire
- Spinal cord injury
- Hypogonadism
- Surgical prostatectomy
- Stable or unstable angina pectoris
- Myocardial infarction, stroke, or life-threatening arrhythmia
- Uncontrolled atrial fibrillation/flutter at screening
- Severe chronic or acute liver disease
- Moderate or severe hepatic impairment
- Clinically significant chronic hematological disease
- Bleeding disorder
- Significant active peptic ulcer disease
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Greenbelt, Maryland, 20770, United States
Unknown Facility
Woodlane, New Jersey, 08060, United States
Unknown Facility
Greer, South Carolina, 29651, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hyungjoo Hugh Lee, MS
Rexahn Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 4, 2008
First Posted
June 6, 2008
Study Start
June 1, 2008
Primary Completion
March 1, 2009
Study Completion
May 1, 2009
Last Updated
May 5, 2009
Record last verified: 2009-05