Phase 2
N=26
Phase 2A Clinical Trial Evaluating the Potential Activity and Safety of hMaxi-K Gene for ED
Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT02713789 ↗Enrolled (actual)
26
Serious AEs
7.7%
Results posted
Aug 2019
Primary outcome: Primary: Number of Participants With Adverse Experiences as Measured by Changes in Physical Examination of the Penis — 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection) (Drug); Placebo (PBS-20% sucrose) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Urovant Sciences GmbH
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Experiences as Measured by Changes in Physical Examination of the Penis |
0; 0; 0 | — |
| PRIMARY Number of Participants With Significant Changes in Clinical Laboratory Parameters as Measured on Interval Blood and Urine Tests |
0; 0; 0 | — |
| PRIMARY Number of Participants With Significant Changes on the Cardiogram as Measured by Significant Prolongation of QT Intervals and Cardiac Rhythm |
0; 2; 0 | — |
| SECONDARY Mean Change From Baseline in the Percentage of "Yes" Responses to Questions 2 and 3 of the Sexual Encounter Profile (SEP) at Week 24 |
-18.8; -16.7; -28.6; -3.1; 0; 0 | 0.827 |
| SECONDARY Change From Baseline in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) at Week 24 |
-0.9; -2.1; -5.3 | 0.384 |
| SECONDARY Change From Baseline in the Orgasmic Function Domain of the International Index of Erectile Function (IIEF) at Week 24 |
-1.5; 1.1; -0.3 | 0.160 |
| SECONDARY Change From Baseline in the Sexual Desire Domain of the International Index of Erectile Function (IIEF) at Week 24 |
-0.9; -1.0; 0.0 | 0.199 |
| SECONDARY Change From Baseline in the Intercourse Satisfaction Domain of the International Index of Erectile Function (IIEF) at Week 24 |
-0.1; -0.3; -2.3 | 0.449 |
| SECONDARY Change From Baseline in the Overall Sexual Satisfaction Domain of the International Index of Erectile Function (IIEF) at Week 24 |
-1.1; 0.1; -1.11 | 0.074 |
| SECONDARY Mean Change From Baseline in the Percentage of "Yes" Responses to Questions 1, 4, and 5 of the Sexual Encounter Profile (SEP) at Week 24 |
15.6; -31.0; -50.0; 12.5; 14.3; 0 | 0.136 |
Summary
To evaluate the safety and efficacy of a single intracavernous injection of hMaxi K (8000 µg and 16000 µg) or placebo upon penile rigidity or erection in males with erectile dysfunction longer than six months that is attributable to an underlying, stable medical condition.
Eligibility Criteria
Inclusion Criteria
- Eligible participants must meet the following inclusion criteria:
- Signed Informed Consent
- Be adult males over 18 years of age diagnosed with erectile dysfunction and whose ED is attributable to an underlying, stable medical condition such as hypertension and atherosclerosis, antihypertensive medication, type I and type II diabetes mellitus, pelvic surgery and pelvic radiation, cerebrovascular accidents (stroke), multiple sclerosis, and Parkinson's disease;
- Participants must have been unable to have successful sexual intercourse for 3 months prior to study entry without specific ED therapy such as Vacuum Erection device (VED), ViagraTM (sildenafil), Cialis TM (tadalafil), MuseTM (alprostadil), or intracavernous injection therapy with an erectile function domain score of IIEF 160 or diastolic >100mmHg)
- Arrhythmia
- Congestive heart failure (dyspnea on minimal exertion or while supine)
- Unstable angina (chest pain greater than three times weekly while on therapy)
- Required treatment with calcium channel, beta-blocker medication, nitrates, or anti-epileptic drugs;
- Poorly controlled diabetes mellitus as defined by HgA1c > 8.0 mg% at time of enrollment;
- Change in medication for diabetes or hypertension within 2 months of study enrollment;
- Gonadal failure (testosterone twice the upper limit of the normal reference range may be accepted with written consent of the sponsor).
- Any clinically significant ECG abnormality
NOTE: Sinus bradycardia of 50-59 bpm is permissible. Other abnormalities that can be normal variants (and considered clinically insignificant) may be permissible. However, participants with such abnormalities cannot be randomized without review of their medical history and prior written approval of the sponsor (or designee).
Data sourced from ClinicalTrials.gov (NCT02713789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.