Erectile Dysfunction (ED)Phase 2NCT00693056
Efficacy Study of RX-10100 to Treat Erectile Dysfunction (ED)
A Phase 2 study testing RX-10100 5mg, RX-10100 10mg and RX-10100 15mg in people with Erectile Dysfunction (ED), run by Rexahn Pharmaceuticals, Inc. at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction (ED)
- What is being tested?
- RX-10100 5mg, RX-10100 10mg and RX-10100 15mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2008to May 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 34Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Greenbelt, Maryland, 20770
Study site
Greer, South Carolina, 29651
Study site
Woodlane, New Jersey, 08060
About this 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)
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.
- Conditions
- Erectile Dysfunction (ED)
- Being tested
- Placebo, RX-10100 5mg, RX-10100 10mg, RX-10100 15mg
- Keywords
- Erectile Dysfunctions, ED
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo (w/o API)
RX-10100 5mgDrug
Also called Zoraxel
5 mg/dose of RX-10100
RX-10100 10mgDrug
Also called Zoraxel
10 mg/dose of RX-10100
RX-10100 15mgDrug
Also called Zoraxel
15 mg/dose of RX-10100
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Experimental | Not described Receives: Drug: RX-10100 5mg |
| 3 | Experimental | Not described Receives: Drug: RX-10100 10mg |
| 4 | Experimental | Not described Receives: Drug: RX-10100 15mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on IIEF-EF Questionnaires and on SEP Questions II and III
Measured: Weeks 4 and 8
Secondary outcomes (1)
Scores on other domains of IIEF, other questions on Subject Diaries, RigiScan measurement, and ED-QoL questionnaires
Measured: Weeks 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction (ED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rexahn Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hyungjoo Hugh Lee, MS, Study director, Rexahn Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693056
- Sponsor's protocol ID
- RX-10100-P2A-001
- Status last verified
- May 2009
- First submitted
- 4 Jun 2008
- Last updated
- 5 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00693056
- Acronym / sponsor ID
- RX-10100-P2A-001
- Conditions
- Erectile Dysfunction (ED)
- Keywords
- Erectile Dysfunctions, ED
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rexahn Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Experimental | Drug: RX-10100 5mg |
| 3 | Experimental | Drug: RX-10100 10mg |
| 4 | Experimental | Drug: RX-10100 15mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (34 listed)
- Following previous or current medical conditions
- Following concomitant medication
- Following abnormal laboratory values
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo (w/o API) | Drug | 1 |
| RX-10100 5mgAlso: Zoraxel5 mg/dose of RX-10100 | Drug | 2 |
| RX-10100 10mgAlso: Zoraxel10 mg/dose of RX-10100 | Drug | 3 |
| RX-10100 15mgAlso: Zoraxel15 mg/dose of RX-10100 | Drug | 4 |
Primary outcome
Scores on IIEF-EF Questionnaires and on SEP Questions II and III
Time frame: Weeks 4 and 8
1 secondary outcome
Scores on other domains of IIEF, other questions on Subject Diaries, RigiScan measurement, and ED-QoL questionnaires
Time frame: Weeks 4 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2009.
Related trials for Erectile Dysfunction (ED)
Recruiting
Embolosclerotherapy Versus Deep Dorsal Vein Revascularization in Venogenic Erectile Dysfunction
Erectile Dysfunction Due to Venous Disorder, Erectile Dysfunction (ED)
Not yet recruiting
Male Pelvic Floor Muscle Rehabilitation Exercises
Erectile Dysfunction, Urinary Incontinence
Active, not recruiting
Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED
Erectile Dysfunction
Not yet recruitingPhase 4
IPP Placement & Intracavernosal Block
Erectile Dysfunction (ED)
Not yet recruitingObservational study
Assessment of Erectile Dysfunction and Coronary Artery Disease Severity
Erectile Dysfunction and Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyungjoo Hugh Lee, MS study director
Rexahn Pharmaceuticals, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RX-10100 5mg, RX-10100 10mg and RX-10100 15mg in people with Erectile Dysfunction (ED), run by Rexahn Pharmaceuticals, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on IIEF-EF Questionnaires and on SEP Questions II and III (time frame: Weeks 4 and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2009.