Clinical trial NCT00693056: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erectile Dysfunction (ED)
Keywords: Erectile Dysfunctions
ED
Lead sponsor: Rexahn Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Scores on IIEF-EF Questionnaires and on SEP Questions II and III
timeFrame: Weeks 4 and 8
Secondary outcomes:
measure: Scores on other domains of IIEF, other questions on Subject Diaries, RigiScan measurement, and ED-QoL questionnaires
timeFrame: Weeks 4 and 8
Other outcomes:
Locations:
city: Greenbelt
country: United States
state: Maryland
city: Westampton
country: United States
state: New Jersey
city: Greer
country: United States
state: South Carolina
Study officials:
affiliation: Rexahn Pharmaceuticals, Inc.
name: Hyungjoo Hugh Lee, MS
role: STUDY_DIRECTOR
References: