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

Sponsor:	Rexahn Pharmaceuticals, Inc.
Information provided by:	Rexahn Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00693056

Purpose

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	Intervention	Phase
Erectile Dysfunction (ED)	Drug: Placebo Drug: RX-10100 5mg Drug: RX-10100 10mg Drug: RX-10100 15mg	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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)

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

U.S. FDA Resources

Further study details as provided by Rexahn Pharmaceuticals, Inc.:

Primary Outcome Measures:

Scores on IIEF-EF Questionnaires and on SEP Questions II and III [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Scores on other domains of IIEF, other questions on Subject Diaries, RigiScan measurement, and ED-QoL questionnaires [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2008
Study Completion Date:	May 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693056

Locations

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

Study Director:

Hyungjoo Hugh Lee, MS

Rexahn Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Hyungjoo Lee / Associate Director, Product Development Management, Rexahn Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00693056 History of Changes
Other Study ID Numbers:	RX-10100-P2A-001
Study First Received:	June 4, 2008
Last Updated:	May 4, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Rexahn Pharmaceuticals, Inc.:

Erectile Dysfunctions
ED

Additional relevant MeSH terms:

Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male

Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012