Efficacy Study of RX-10100 to Treat Erectile Dysfunction (ED)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Erectile Dysfunction (ED)

Intervention / Treatment
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* Drug: Placebo
* Drug: RX-10100 5mg
* Drug: RX-10100 10mg
* Drug: RX-10100 15mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* Placebo (w/o API)<br>|
| Experimental: 2<br> | Drug: RX-10100 5mg<br>* 5 mg/dose of RX-10100<br>* Other names: Zoraxel;|
| Experimental: 3<br> | Drug: RX-10100 10mg<br>* 10 mg/dose of RX-10100<br>* Other names: Zoraxel;|
| Experimental: 4<br> | Drug: RX-10100 15mg<br>* 15 mg/dose of RX-10100<br>* Other names: Zoraxel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on IIEF-EF Questionnaires and on SEP Questions II and III |  | Weeks 4 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on other domains of IIEF, other questions on Subject Diaries, RigiScan measurement, and ED-QoL questionnaires |  | Weeks 4 and 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunctions, ED