Trial | NCT00693056  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    clavulanate ...

  • Study Participants

    40
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.
Study Started
Jun 30
2008
Primary Completion
Mar 31
2009
Study Completion
May 31
2009
Last Update
May 05
2009
Estimate

Drug Placebo

Placebo (w/o API)

Drug RX-10100 5mg

5 mg/dose of RX-10100

  • Other names: Zoraxel

Drug RX-10100 10mg

10 mg/dose of RX-10100

  • Other names: Zoraxel

Drug RX-10100 15mg

15 mg/dose of RX-10100

  • Other names: Zoraxel

1 Placebo Comparator

2 Experimental

3 Experimental

4 Experimental

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
No Results Posted