search
Back to results

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

Primary Purpose

Erectile Dysfunction (ED)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
RX-10100 5mg
RX-10100 10mg
RX-10100 15mg
Sponsored by
Rexahn Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction (ED) focused on measuring Erectile Dysfunctions, ED

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Scores on IIEF-EF Questionnaires and on SEP Questions II and III

Secondary Outcome Measures

Scores on other domains of IIEF, other questions on Subject Diaries, RigiScan measurement, and ED-QoL questionnaires

Full Information

First Posted
June 4, 2008
Last Updated
May 4, 2009
Sponsor
Rexahn Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00693056
Brief Title
Efficacy Study of RX-10100 to Treat Erectile Dysfunction (ED)
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 Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rexahn Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction (ED)
Keywords
Erectile Dysfunctions, ED

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyungjoo Hugh Lee, MS
Organizational Affiliation
Rexahn Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
City
Westampton
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs