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

This study has been completed.

Sponsor:

Information provided by:

Rexahn Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00693056

First received: June 4, 2008

Last updated: May 4, 2009

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

June 4, 2008

Last Updated Date

May 4, 2009

Start Date ^ICMJE

June 2008

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00693056 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Erectile Dysfunction (ED)

Intervention ^ICMJE

Drug: Placebo
Placebo (w/o API)
Drug: RX-10100 5mg
5 mg/dose of RX-10100

Other Name: Zoraxel
Drug: RX-10100 10mg
10 mg/dose of RX-10100

Other Name: Zoraxel
Drug: RX-10100 15mg
15 mg/dose of RX-10100

Other Name: Zoraxel

Study Arm (s)

Placebo Comparator: 1
Intervention: Drug: Placebo
Experimental: 2
Intervention: Drug: RX-10100 5mg
Experimental: 3
Intervention: Drug: RX-10100 10mg
Experimental: 4
Intervention: Drug: RX-10100 15mg

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

May 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00693056

Other Study ID Numbers ^ICMJE

RX-10100-P2A-001

Has Data Monitoring Committee

Responsible Party

Hyungjoo Lee / Associate Director, Product Development Management, Rexahn Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

Rexahn Pharmaceuticals, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Hyungjoo Hugh Lee, MS

Rexahn Pharmaceuticals, Inc.

Information Provided By

Rexahn Pharmaceuticals, Inc.

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top