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Completed

NCT Number: NCT00693056

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

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.

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Key information

Conditions

Erectile Dysfunction (ED) Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Greenbelt, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo (w/o API)

RX-10100 5mg

Drug

5 mg/dose of RX-10100

Other names: Zoraxel

RX-10100 10mg

Drug

10 mg/dose of RX-10100

Other names: Zoraxel

RX-10100 15mg

Drug

15 mg/dose of RX-10100

Other names: Zoraxel

Primary outcomes

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

    Time frame: Weeks 4 and 8

Secondary outcomes

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

    Time frame: Weeks 4 and 8

Sponsors and collaborators

Lead sponsor

Rexahn Pharmaceuticals, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 6, 2008
Registry last updated
May 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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