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Sponsored by: |
Rexahn Pharmaceuticals, Inc. |
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Information provided by: | Rexahn Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00693056 |
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: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 40 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator |
Drug: Placebo
Placebo (w/o API)
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2: Experimental |
Drug: RX-10100 5mg
5 mg/dose of RX-10100
|
3: Experimental |
Drug: RX-10100 10mg
10 mg/dose of RX-10100
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4: Experimental |
Drug: RX-10100 15mg
15 mg/dose of RX-10100
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Following previous or current medical conditions
Following concomitant medication
Following abnormal laboratory values
Contact: Hyungjoo (Hugh) Lee, MS | 240-268-5300 ext 315 | leehj@rexahn.com |
United States, Maryland | |
Recruiting | |
Greenbelt, Maryland, United States, 20770 | |
United States, New Jersey | |
Recruiting | |
Westampton, New Jersey, United States, 08060 | |
United States, South Carolina | |
Recruiting | |
Greer, South Carolina, United States, 29651 |
Study Director: | Hyungjoo Lee, MS | Rexahn Pharmaceuticals, Inc. |
Responsible Party: | Rexahn Pharmaceuticals, Inc. ( Hyungjoo Lee / Associate Director, Product Development Management ) |
Study ID Numbers: | RX-10100-P2A-001 |
Study First Received: | June 4, 2008 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00693056 |
Health Authority: | United States: Food and Drug Administration |
Erectile Dysfunctions ED |
Sexual Dysfunctions, Psychological Sexual Dysfunction, Physiological Mental Disorders Genital Diseases, Male Erectile Dysfunction |
Sexual and Gender Disorders |