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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
Sponsor:
Information provided by:
Rexahn Pharmaceuticals, Inc.

Study Description
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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.

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 Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Scores on IIEF-EF Questionnaires and on SEP Questions II and III [ Time Frame: Weeks 4 and 8 ]

Secondary Outcome Measures :
  1. Scores on other domains of IIEF, other questions on Subject Diaries, RigiScan measurement, and ED-QoL questionnaires [ Time Frame: Weeks 4 and 8 ]

Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Rexahn Pharmaceuticals, Inc.
Investigators
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Study Director: Hyungjoo Hugh Lee, MS Rexahn Pharmaceuticals, Inc.
More Information
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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
Keywords provided by Rexahn Pharmaceuticals, Inc.:
Erectile Dysfunctions
ED
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
 beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents