Erectile DysfunctionPhase 2NCT02713789
Phase 2A Clinical Trial Evaluating the Potential Activity and Safety of hMaxi-K Gene for ED
A Phase 2 study testing hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection) in people with Erectile Dysfunction, run by Urovant Sciences GmbH at 1 site in Kuwait.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteKuwait
- Study dates
- Apr 2015to 24 Aug 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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<21 at screening and baseline;
- Have been unable to tolerate, do not wish to continue, or have had unsuccessful results with, prior therapy for ED, e.g., ViagraTM, intracavernous injection therapy, MuseTM, or VED;
- If diabetic, documentation of HgA1c less than or equal to 8.0% prior to enrollment;
Show all 15Show fewer
- If receiving medication for hypertension, documentation of blood pressure has been stable on the same medication for at least 2 months prior to enrollment;
- Be heterosexual and in a stable, monogamous relationship of at least six months duration;
- Agree to attempt intercourse with their partner at least four times per month while participating in the study;
- Agree not to use other treatments for ED while participating in this study;
- Have screening laboratory values and ECG that are within the normal range. See exclusion criterion below.
- A prior penile prosthetic implant;
- Have a normal physical examination of the penis;
- If participant had a radical prostatectomy a PSA <0.4 for at least one year documented by 2 measurements during the preceding year;
- Be literate, able to give written informed consent, and comply with all study procedures and requirements.
Who cannot join
- A history of sickle-cell disease, sickle cell trait, or any other medical condition that, in the judgment of the investigator, would contraindicate the administration of study medication or interfere with the study evaluations;
- In the judgment of the investigator any condition that would interfere with participation in the study (including geographical inaccessibility), that would contraindicate the administration of study medication or interfere with the study evaluations.
- Had within six months prior to enrollment any of the following:
- Myocardial infarction
- Cerebrovascular accident
- Uncontrolled hypertension (systolic >160 or diastolic >100mmHg)
Show all 22Show fewer
- 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 < 200 ng/dl) not treated with hormone replacement;
- History of malignancy except non-melanomatous skin cancers;
- A life expectancy of less than 12 months;
- An indwelling urethral catheter;
- A prior penile prosthetic implant;
- Received an investigational drug, investigational therapy, or other form of ED therapy, including approved treatments, within the past 30 days;
- Peyronie's disease;
- Any screening laboratory values outside of the normal laboratory range as defined by the central laboratory normal ranges and in the judgment of the investigator is considered clinically significant (hepatic biochemical markers [AST, ALT, GGT, alkaline phosphatase, and bilirubin] > 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Parallel Design, Randomized, Phase 2A Clinical Trial Evaluating the Potential Activity and Safety of hMaxi-K Gene Transfer in Males With Erectile Dysfunction
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.
Read the detailed description
This study is a double-blind, placebo controlled, parallel design, Phase 2A study evaluating the potential activity and safety of a single administration of hMaxi-K (8000 or 16000 µg) or placebo (PBS sucrose 20%) injected into the corpus cavernosum of the penis in men who have been unable to tolerate, do not wish to continue, or have had unsuccessful results with, prior therapy for ED.
The study population is men with erectile dysfunction attributable to an underlying, stable medical condition but who are otherwise in good health. The target population is men with erectile dysfunction and those who have been unable to tolerate, do not wish to continue, or have had unsuccessful results with, prior therapy for ED and with an erectile function domain score of IIEF < 21 at screening and baseline.
Following screening and study drug administration at Week 0 (Visit 2 [V2]), eligible participants will be evaluated at Weeks 1 (V3), 4 (V4), 8 (V5), 12 (V6), and 24 (V7). At each study visit, participants will have a physical examination including examination of the penis (all visits), vital signs, electrocardiogram (ECG) (all visits). Laboratory evaluations including chemistry and hematology will be done at V1, V3, V4, V6, and V7. Urinalysis will be done V1, V2 (prior to dosing), V3, V4, V6, and V7. Endocrine parameters and PTT, PT, sed rate and CRP will be evaluated at V1, V3, and V7. The participant will complete the erectile function domain of the IIEF and Sexual Encounter Profile (SEP) at screening/baseline and at V2, (SEP and IIEF at V2 prior to dosing) V3, V4, V5, V6, and V7. In all participants, plasma specimens will be collected to assay for the presence of hSlo DNA by PCR (V2-V7). These will be kept frozen at -20°C or less at the site for eventual assay by Sponsor.
The primary efficacy outcome measures will include the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), Questions 2 and 3 from SEP. The IIEF EF domain has a 30-point total score, where higher scores reflect better erectile function. SEP is a diary in which participants record each sexual attempt made throughout the study. The two questions from the Sexual Encounter Profile (SEP) deal with the ability to achieve vaginal penetration (SEP2), and the ability to maintain an erection long enough for successful intercourse (SEP3). The erectile function domain category of the IIEF will be used to evaluate the change in erectile status from baseline following administration of hMaxi-K. Change from baseline on the six questions of the IIEF's Erectile function domain category at every visit after administration of study drug will be calculated and compared among the two dose and one placebo groups.
Safety will be assessed by analysis of adverse experiences, and abnormal findings on clinical laboratory tests, electrocardiogram, and physical examinations.
6 months per participant (approximately 2 years to enroll all participants)
A total of 35 participants were planned to be enrolled; N=11 on 8000 µg; N=11 on 16000 µg; N=13 on placebo.
Both the safety data and data to assess activity will be presented as means and standard deviations or medians and ranges as appropriate for continuous data, and analyzed using either paired t- or Wilcox on Sign Rank tests for within group changes, and with mixed effects or marginal models to determine differences in trends among the three cohorts over time. Incidence of adverse events will be presented as relative frequencies within groups.
- Conditions
- Erectile Dysfunction
- Being tested
- hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection), Placebo (PBS-20% sucrose)
- Keywords
- 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.
hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection)Drug
Also called hMaxi-K, URO-902
Placebo (PBS-20% sucrose)Drug
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| hMaxi-K | Active comparator | Single Treatment/ two escalating dose levels (8000 µg and 16,000 µg injection). In each dose level, 11 participants will receive hMaxi-K and 6 will receive placebo (only one injection per each participant) Receives: Drug: hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection) |
| Placebo (PBS-20% sucrose) | Placebo comparator | PBS-20% sucrose administered during two single treatment dose levels (8000 µg and 16000 µg) by injection (only one injection per each participant) Receives: Drug: Placebo (PBS-20% sucrose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Experiences as Measured by Changes in Physical Examination of the Penis
Physical examination of the penis included inspection and palpation.
Measured: up to Week 24 ± 3 days
Number of Participants With Significant Changes in Clinical Laboratory Parameters as Measured on Interval Blood and Urine Tests
Clinical significance was determined by the Investigator using central laboratory values.
Measured: up to Week 24 ± 3 days
Number of Participants With Significant Changes on the Cardiogram as Measured by Significant Prolongation of QT Intervals and Cardiac Rhythm
Clinical significance was determined by the Investigator using central laboratory values.
Measured: up to Week 24 ± 3 days
Secondary outcomes (7)
Mean Change From Baseline in the Percentage of "Yes" Responses to Questions 2 and 3 of the Sexual Encounter Profile (SEP) at Week 24
SEP is a diary in which participants record each sexual attempt made throughout the study and is composed of 5 questions assessing sexual function. Two questions from the SEP deal with the ability to achieve vaginal penetration (Question 2: Were you able to insert your penis into your partner's vagina?), and the ability to maintain an erection (Question 3: Did your erection last long enough for you to have successful intercourse?). The number of "yes" response to each question in the SEP was computed as (Sum of all "yes" responses to respective SEP question /Total number of responses to that SEP question)*100. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Week 24
Change From Baseline in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) at Week 24
The IIEF is a validated, self-administered questionnaire that is a valid measure of male erectile dysfunction. The test contains 15 questions in 5 domains: (1) Erectile duration/function (questions [Q] 01 to 05 and 15); (2) Orgasmic function (questions 09 and 10); (3) Sexual desire (questions 11 and 12); (4) Intercourse satisfaction (questions 06, 07, and 08); (5) Overall sexual satisfaction (questions 13 and 14). The EF domain has been validated to assess erectile changes only. The domain-specific scores were calculated as the sum of the scores of the questions in the respective domain; thus, the total score of the EF domain was the sum of the 6 questions. Score range: 0 to 5 (Q01 to Q05), 1 to 5 (Q15). Total score: 1 to 30. Higher scores reflect better erectile function. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
Measured: Baseline; Week 24
Change From Baseline in the Orgasmic Function Domain of the International Index of Erectile Function (IIEF) at Week 24
The IIEF is a validated, self-administered questionnaire that is a valid measure of male erectile dysfunction. The test contains 15 questions in 5 domains: (1) Erectile duration/function (questions 01 to 05 and 15); (2) Orgasmic function (questions 09 and 10); (3) Sexual desire (questions 11 and 12); (4) Intercourse satisfaction (questions 06, 07, and 08); (5) Overall sexual satisfaction (questions 13 and 14). The domain-specific scores were calculated as the sum of the scores of the questions in the respective domain; thus, the total score of the Orgasmic Function domain was the sum of 2 questions. Score range: 0 to 5 (Q09 and Q10). Total score: 0 to 10. Higher scores reflect better erectile function. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
Measured: Baseline; Week 24
Change From Baseline in the Sexual Desire Domain of the International Index of Erectile Function (IIEF) at Week 24
The IIEF is a validated, self-administered questionnaire that is a valid measure of male erectile dysfunction. The test contains 15 questions in 5 domains: (1) Erectile duration/function (questions 01 to 05 and 15); (2) Orgasmic function (questions 09 and 10); (3) Sexual desire (questions 11 and 12); (4) Intercourse satisfaction (questions 06, 07, and 08); (5) Overall sexual satisfaction (questions 13 and 14). The domain-specific scores were calculated as the sum of the scores of the questions in the respective domain; thus, the total score of the Sexual Desire domain was the sum of 2 questions. Score range: 1 to 5 (Q11 and Q12). Total score: 2 to 10. Higher scores reflect better erectile function. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
Measured: Baseline; Week 24
Change From Baseline in the Intercourse Satisfaction Domain of the International Index of Erectile Function (IIEF) at Week 24
The IIEF is a validated, self-administered questionnaire that is a valid measure of male erectile dysfunction. The test contains 15 questions in 5 domains: (1) Erectile duration/function (questions 01 to 05 and 15); (2) Orgasmic function (questions 09 and 10); (3) Sexual desire (questions 11 and 12); (4) Intercourse satisfaction (questions 06, 07, and 08); (5) Overall sexual satisfaction (questions 13 and 14). The domain-specific scores were calculated as the sum of the scores of the questions in the respective domain; thus, the total score of the Intercourse Satisfaction domain was the sum of 3 questions. Score range: 0 to 5 (Q06 through Q8). Total score: 0 to 15. Higher scores reflect better erectile function. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
Measured: Baseline; Week 24
Change From Baseline in the Overall Sexual Satisfaction Domain of the International Index of Erectile Function (IIEF) at Week 24
The IIEF is a validated, self-administered questionnaire that is a valid measure of male erectile dysfunction. The test contains 15 questions in 5 domains: (1) Erectile duration/function (questions 01 to 05 and 15); (2) Orgasmic function (questions 09 and 10); (3) Sexual desire (questions 11 and 12); (4) Intercourse satisfaction (questions 06, 07, and 08); (5) Overall sexual satisfaction (questions 13 and 14). The domain-specific scores were calculated as the sum of the scores of the questions in the respective domain; thus, the total score of the Overall Sexual Satisfaction domain was the sum of 2 questions. Score range: 1 to 5 (Q13 and Q14). Total score: 2 to 10. Higher scores reflect better erectile function. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
Measured: Baseline; Week 24
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
SEP is a diary in which participants record each sexual attempt made throughout the study and is composed of 5 questions assessing sexual function. Question 1: Were you able to achieve at least some erection?; Question 4: Were you satisfied with the hardness of your erection?; Question 5: Overall, were you satisfied with the sexual experience? The number of "yes" response to each question in the SEP was computed as (Sum of all "yes" responses to respective SEP question /Total number of responses to that SEP question)*100. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startApr 2015
- Primary completion24 Aug 2017
- Study completion24 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erectile DysfunctionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urovant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dasman Diabetes Institute, Ion Channel Innovations
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713789
- Sponsor's protocol ID
- ION04-ED
- Status last verified
- Jul 2019
- First submitted
- 1 Mar 2016
- Last updated
- 8 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Parallel Design, Randomized, Phase 2A Clinical Trial Evaluating the Potential Activity and Safety of hMaxi-K Gene Transfer in Males With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT02713789
- Acronym / sponsor ID
- ION04-ED
- Conditions
- Erectile Dysfunction
- Keywords
- ED
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Urovant Sciences GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Dasman Diabetes Institute, Ion Channel Innovations
- Study start
- Apr 2015
- Primary completion
- 24 Aug 2017 (actual)
- Study completion
- 24 Aug 2017 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Posted 8 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a double-blind, placebo controlled, parallel design, Phase 2A study evaluating the potential activity and safety of a single administration of hMaxi-K (8000 or 16000 µg) or placebo (PBS sucrose 20%) injected into the corpus cavernosum of the penis in men who have been unable to tolerate, do not wish to continue, or have had unsuccessful results with, prior therapy for ED.
The study population is men with erectile dysfunction attributable to an underlying, stable medical condition but who are otherwise in good health. The target population is men with erectile dysfunction and those who have been unable to tolerate, do not wish to continue, or have had unsuccessful results with, prior therapy for ED and with an erectile function domain score of IIEF < 21 at screening and baseline.
Following screening and study drug administration at Week 0 (Visit 2 [V2]), eligible participants will be evaluated at Weeks 1 (V3), 4 (V4), 8 (V5), 12 (V6), and 24 (V7). At each study visit, participants will have a physical examination including examination of the penis (all visits), vital signs, electrocardiogram (ECG) (all visits). Laboratory evaluations including chemistry and hematology will be done at V1, V3, V4, V6, and V7. Urinalysis will be done V1, V2 (prior to dosing), V3, V4, V6, and V7. Endocrine parameters and PTT, PT, sed rate and CRP will be evaluated at V1, V3, and V7. The participant will complete the erectile function domain of the IIEF and Sexual Encounter Profile (SEP) at screening/baseline and at V2, (SEP and IIEF at V2 prior to dosing) V3, V4, V5, V6, and V7. In all participants, plasma specimens will be collected to assay for the presence of hSlo DNA by PCR (V2-V7). These will be kept frozen at -20°C or less at the site for eventual assay by Sponsor.
The primary efficacy outcome measures will include the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), Questions 2 and 3 from SEP. The IIEF EF domain has a 30-point total score, where higher scores reflect better erectile function. SEP is a diary in which participants record each sexual attempt made throughout the study. The two questions from the Sexual Encounter Profile (SEP) deal with the ability to achieve vaginal penetration (SEP2), and the ability to maintain an erection long enough for successful intercourse (SEP3). The erectile function domain category of the IIEF will be used to evaluate the change in erectile status from baseline following administration of hMaxi-K. Change from baseline on the six questions of the IIEF's Erectile function domain category at every visit after administration of study drug will be calculated and compared among the two dose and one placebo groups.
Safety will be assessed by analysis of adverse experiences, and abnormal findings on clinical laboratory tests, electrocardiogram, and physical examinations.
6 months per participant (approximately 2 years to enroll all participants)
A total of 35 participants were planned to be enrolled; N=11 on 8000 µg; N=11 on 16000 µg; N=13 on placebo.
Both the safety data and data to assess activity will be presented as means and standard deviations or medians and ranges as appropriate for continuous data, and analyzed using either paired t- or Wilcox on Sign Rank tests for within group changes, and with mixed effects or marginal models to determine differences in trends among the three cohorts over time. Incidence of adverse events will be presented as relative frequencies within groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hMaxi-K | Active comparator | Drug: hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection)Single Treatment/ two escalating dose levels (8000 µg and 16,000 µg injection). In each dose level, 11 participants will receive hMaxi-K and 6 will receive placebo (only one injection per each participant) |
| Placebo (PBS-20% sucrose) | Placebo comparator | Drug: Placebo (PBS-20% sucrose)PBS-20% sucrose administered during two single treatment dose levels (8000 µg and 16000 µg) by injection (only one injection per each participant) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Eligible participants must meet the following inclusion criteria:
Key exclusion criteria (22 listed)
- A history of sickle-cell disease, sickle cell trait, or any other medical condition that, in the judgment of the investigator, would contraindicate the administration of study medication or interfere with the study evaluations;
- In the judgment of the investigator any condition that would interfere with participation in the study (including geographical inaccessibility), that would contraindicate the administration of study medication or interfere with the study evaluations.
- Had within six months prior to enrollment any of the following:
- 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;
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 |
|---|---|---|
| hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection)Also: hMaxi-K, URO-902 | Drug | hMaxi-K |
| Placebo (PBS-20% sucrose)Also: Placebo | Drug | Placebo (PBS-20% sucrose) |
Primary outcome
Number of Participants With Adverse Experiences as Measured by Changes in Physical Examination of the Penis
Time frame: up to Week 24 ± 3 days
Physical examination of the penis included inspection and palpation.
Number of Participants With Significant Changes in Clinical Laboratory Parameters as Measured on Interval Blood and Urine Tests
Time frame: up to Week 24 ± 3 days
Clinical significance was determined by the Investigator using central laboratory values.
Number of Participants With Significant Changes on the Cardiogram as Measured by Significant Prolongation of QT Intervals and Cardiac Rhythm
Time frame: up to Week 24 ± 3 days
Clinical significance was determined by the Investigator using central laboratory values.
7 secondary outcomes
Mean Change From Baseline in the Percentage of "Yes" Responses to Questions 2 and 3 of the Sexual Encounter Profile (SEP) at Week 24
Time frame: Baseline; Week 24
Change From Baseline in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) at Week 24
Time frame: Baseline; Week 24
Change From Baseline in the Orgasmic Function Domain of the International Index of Erectile Function (IIEF) at Week 24
Time frame: Baseline; Week 24
Change From Baseline in the Sexual Desire Domain of the International Index of Erectile Function (IIEF) at Week 24
Time frame: Baseline; Week 24
Change From Baseline in the Intercourse Satisfaction Domain of the International Index of Erectile Function (IIEF) at Week 24
Time frame: Baseline; Week 24
Change From Baseline in the Overall Sexual Satisfaction Domain of the International Index of Erectile Function (IIEF) at Week 24
Time frame: Baseline; Week 24
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
Time frame: Baseline; Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection) in people with Erectile Dysfunction, run by Urovant Sciences GmbH at 1 site in Kuwait.
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 15 inclusion and 22 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 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. 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?
Yes. Results are posted in the registry (first posted 8 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Experiences as Measured by Changes in Physical Examination of the Penis (time frame: up to Week 24 ± 3 days). The study lists 3 primary outcomes in all. 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 8 Aug 2019.