Efficacy Study of RX-10100 to Treat Erectile Dysfunction (ED)
May 4, 2009 updated by: Rexahn Pharmaceuticals, Inc.
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Greenbelt, Maryland, United States, 20770
-
-
New Jersey
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Westampton, New Jersey, United States, 08060
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South Carolina
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Greer, South Carolina, United States, 29651
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- Resting hypotension or hypertension
- Malignancy (cancers)
- NYHA Class II to IV heart failures
- Positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C
- Symptomatic postural hypotension
Following concomitant medication
- Androgens or estrogens
- Anti-androgens
- Potent inhibitors of cytochrome P450 3A4
- Any other investigational drug within 30 days before Visit 1
- Any treatment for ED within 7 days before Visit 1 or during the study
- Antibiotics in the penicillin class
Following abnormal laboratory values
- Serum total testosterone level (at least 25% lower)
- Serum creatinine (> 3.0 mg/dl)
- Elevation of AST and/or ALT (> 3 times the upper limit of normal)
- Diabetic subjects with an HbAlc (> 6.5%)
- Subjects with known hypersensitivity to amoxicillin
- Subjects with a history of unresponsiveness to any PDE5 Inhibitor treatment or a history of significant side effects leading to its treatment discontinuation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 2
|
5 mg/dose of RX-10100
Other Names:
|
|
EXPERIMENTAL: 3
|
10 mg/dose of RX-10100
Other Names:
|
|
PLACEBO_COMPARATOR: 1
|
Placebo (w/o API)
|
|
EXPERIMENTAL: 4
|
15 mg/dose of RX-10100
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Scores on IIEF-EF Questionnaires and on SEP Questions II and III
Time Frame: Weeks 4 and 8
|
Weeks 4 and 8
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Scores on other domains of IIEF, other questions on Subject Diaries, RigiScan measurement, and ED-QoL questionnaires
Time Frame: Weeks 4 and 8
|
Weeks 4 and 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hyungjoo Hugh Lee, MS, Rexahn Pharmaceuticals, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (ACTUAL)
March 1, 2009
Study Completion (ACTUAL)
May 1, 2009
Study Registration Dates
First Submitted
June 4, 2008
First Submitted That Met QC Criteria
June 4, 2008
First Posted (ESTIMATE)
June 6, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
May 5, 2009
Last Update Submitted That Met QC Criteria
May 4, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RX-10100-P2A-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.