Efficacy Study of RX-10100 to Treat Erectile Dysfunction (ED)
NCT ID: NCT00693056
Last Updated: 2009-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2008-06-30
2009-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED
NCT00790751
Treatment of Erectile Dysfunction - Long Term Safety and Efficacy
NCT01065012
Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction
NCT00853606
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil
NCT00903981
Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction
NCT01698684
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Placebo
Placebo (w/o API)
2
RX-10100 5mg
5 mg/dose of RX-10100
3
RX-10100 10mg
10 mg/dose of RX-10100
4
RX-10100 15mg
15 mg/dose of RX-10100
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Placebo (w/o API)
RX-10100 5mg
5 mg/dose of RX-10100
RX-10100 10mg
10 mg/dose of RX-10100
RX-10100 15mg
15 mg/dose of RX-10100
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
65 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rexahn Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rexahn Pharmaceuticals, Inc.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hyungjoo Hugh Lee, MS
Role: STUDY_DIRECTOR
Rexahn Pharmaceuticals, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Greenbelt, Maryland, United States
Woodlane, New Jersey, United States
Greer, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RX-10100-P2A-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.