Efficacy Study of RX-10100 to Treat Erectile Dysfunction (ED)
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ClinicalTrials.gov Identifier: NCT00693056 |
Recruitment Status :
Completed
First Posted : June 6, 2008
Last Update Posted : May 5, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Erectile Dysfunction (ED) | Drug: Placebo Drug: RX-10100 5mg Drug: RX-10100 10mg Drug: RX-10100 15mg | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | May 2009 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1 |
Drug: Placebo
Placebo (w/o API) |
Experimental: 2 |
Drug: RX-10100 5mg
5 mg/dose of RX-10100
Other Name: Zoraxel |
Experimental: 3 |
Drug: RX-10100 10mg
10 mg/dose of RX-10100
Other Name: Zoraxel |
Experimental: 4 |
Drug: RX-10100 15mg
15 mg/dose of RX-10100
Other Name: Zoraxel |
- Scores on IIEF-EF Questionnaires and on SEP Questions II and III [ Time Frame: Weeks 4 and 8 ]
- Scores on other domains of IIEF, other questions on Subject Diaries, RigiScan measurement, and ED-QoL questionnaires [ Time Frame: Weeks 4 and 8 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693056
United States, Maryland | |
Greenbelt, Maryland, United States, 20770 | |
United States, New Jersey | |
Westampton, New Jersey, United States, 08060 | |
United States, South Carolina | |
Greer, South Carolina, United States, 29651 |
Study Director: | Hyungjoo Hugh Lee, MS | Rexahn Pharmaceuticals, Inc. |
Responsible Party: | Hyungjoo Lee / Associate Director, Product Development Management, Rexahn Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00693056 |
Other Study ID Numbers: |
RX-10100-P2A-001 |
First Posted: | June 6, 2008 Key Record Dates |
Last Update Posted: | May 5, 2009 |
Last Verified: | May 2009 |
Erectile Dysfunctions ED |
Erectile Dysfunction Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders |
beta-Lactams Anti-Bacterial Agents Anti-Infective Agents |