A Phase 2 interventional study of IX-01 and Placebo in Premature Ejaculation, sponsored by Ixchelsis Limited. Completed at 10 sites in 2 countries. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-08-17.
Sponsored by Ixchelsis Limited · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong premature ejaculation.
106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
This study's enrollment of 88 is close to the median of 84 across 89 interventional studies indexed under Premature Ejaculation.
Browse Premature Ejaculation studies →Ixchelsis Limited is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity
Drug: IX-01
Two to four capsules administered orally, 1-6 hours prior to sexual activity
Drug: Placebo
Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)
IX-01 versus placebo. Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred
Time frame: Last 4 weeks of treatment compared to baseline
Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale
7 point scale ranging from much worse (-3) to much better (3). The proportion refers to the proportion of patients who had the best 2 possible responses \[better(2) or much better (3)\] on this 7 point scale
Time frame: Baseline to the end of treatment (approximately 8 weeks)
Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT)
Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred. Outcome measured proportion of patients with at least a 2.5-fold increase in geometric mean IELT over the last 4 weeks of treatment as compared to baseline. Proportion of participants adjusted for baseline IELT, country and site
Time frame: Last 4 weeks of treatment compared to baseline
Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time)
IX-01 versus placebo
Time frame: Last 4 weeks of treatment compared to baseline
Mean Change in Score on Control of Timing of Ejaculation
Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP question on control of timing is scored on a 5 point scale with the scores ranging from very poor (this is the worst answer) scored as 0 to very good (this is the best answer scored as 4)
Time frame: Last 4 weeks of treatment compared to baseline
Mean Change in Score on Ejaculation-related Personal Distress
Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.
Time frame: Last 4 weeks of treatment compared to baseline
Proportion of Participants With ≥ 1 Category of Improvement in Satisfaction With Sexual Intercourse, on the Premature Ejaculation Profile (PEP) Questionnaire
Based on Premature Ejaculation Profile (PEP) 5 point scale with the scores ranging from 0 (worse answer) to 4 (best answer).
Time frame: Baseline to 8 weeks
Proportion of Participants With ≥ 1 Category of Improvement in Control Over Ejaculation During Sexual Intercourse on the Premature Ejaculation Profile (PEP) Questionnaire
Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)
Time frame: Baseline to 8 weeks
Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Distress on the Premature Ejaculation Profile ( PEP) Questionnaire
Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.
Time frame: Baseline to 8 weeks
Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Interpersonal Difficulty on the Premature Ejaculation Profile (PEP) Questionnaire
Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.
Time frame: Baseline to 8 weeks
Proportion of Participants With ≥ 2 Category Increase in Control and ≥ 1 Category Decrease in Personal Distress on a Patient Reported Outcome (PRO) Measure
Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Each of the PEP questions is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)
Time frame: Baseline to 8 weeks
Change in Percentage of Intercourse Attempts Lasting Longer Than 1 Minute From Baseline to Last 4 Weeks on Treatment
'Baseline' time period defined as Day -28 - Day 0. 'Last 4 Weeks' time period defined as the 28 days prior to last time subject took study drug and after Day 14. Analysis excludes two subjects from ITT population: #010-012 (placebo) and #888-018 (active). Adjusted for treatment, baseline IELT, baseline percentage, country and site.
Time frame: Baseline to last 4 weeks on treatment
Incidence of Treatment-emergent Adverse Events
Number of participants with at least one treatment-emergent adverse event
Time frame: Start of Treatment to end of study (approximately 10 weeks)
| Milestone | Drug: IX-01 | Placebo |
|---|---|---|
| Started | 58 | 30 |
| Completed | 44 | 22 |
| Not completed | 14 | 8 |
| Withdrew: Lost to follow-up | 6 | 2 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Withdrawal by subject | 5 | 6 |
| Withdrew: Lack of efficacy | 1 | 0 |
IX-01 versus placebo. Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred
| No units for fold change | Drug: IX-01 | Placebo |
|---|---|---|
| Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | 2.1 (1.5 to 3.1) | 1.1 (0.7 to 1.8) |
7 point scale ranging from much worse (-3) to much better (3). The proportion refers to the proportion of patients who had the best 2 possible responses \[better(2) or much better (3)\] on this 7 point scale
| proportion of participants | Drug: IX-01 | Placebo |
|---|---|---|
| Better/Much Better | 0.17 | 0 |
| Any Improvement | 0.44 | 0.13 |
Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred. Outcome measured proportion of patients with at least a 2.5-fold increase in geometric mean IELT over the last 4 weeks of treatment as compared to baseline. Proportion of participants adjusted for baseline IELT, country and site
| Proportion of participants | Drug: IX-01 | Placebo |
|---|---|---|
| Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT) | 0.31 (0.14 to 0.54) | 0.07 (0.01 to 0.32) |
IX-01 versus placebo
| No units for fold change | Drug: IX-01 | Placebo |
|---|---|---|
| Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time) | 3.6 (2.2 to 5.0) | 1.8 (0.9 to 2.7) |
Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP question on control of timing is scored on a 5 point scale with the scores ranging from very poor (this is the worst answer) scored as 0 to very good (this is the best answer scored as 4)
| units on a scale | Drug: IX-01 | Placebo |
|---|---|---|
| Mean Change in Score on Control of Timing of Ejaculation | 0.42 (-0.08 to 0.93) | -0.03 (-0.59 to 0.53) |
Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.
| units on a scale | Drug: IX-01 | Placebo |
|---|---|---|
| Mean Change in Score on Ejaculation-related Personal Distress | 0.63 (0.37 to 0.88) | 0.03 (-0.34 to 0.40) |
Based on Premature Ejaculation Profile (PEP) 5 point scale with the scores ranging from 0 (worse answer) to 4 (best answer).
| adjusted proportion of participants | Drug: IX-01 | Placebo |
|---|---|---|
| Proportion of Participants With ≥ 1 Category of Improvement in Satisfaction With Sexual Intercourse, on the Premature Ejaculation Profile (PEP) Questionnaire | 0.53 (0.33 to 0.72) | 0.30 (0.13 to 0.56) |
Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)
| adjusted proportion of participants | Drug: IX-01 | Placebo |
|---|---|---|
| Proportion of Participants With ≥ 1 Category of Improvement in Control Over Ejaculation During Sexual Intercourse on the Premature Ejaculation Profile (PEP) Questionnaire | 0.56 (0.42 to 0.69) | 0.36 (0.19 to 0.58) |
Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.
| adjusted proportion of participants | Drug: IX-01 | Placebo |
|---|---|---|
| Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Distress on the Premature Ejaculation Profile ( PEP) Questionnaire | 0.60 (0.46 to 0.73) | 0.36 (0.19 to 0.57) |
Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.
| adjusted proportion of participants | Drug: IX-01 | Placebo |
|---|---|---|
| Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Interpersonal Difficulty on the Premature Ejaculation Profile (PEP) Questionnaire | 0.60 (0.45 to 0.72) | 0.48 (0.29 to 0.68) |
Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Each of the PEP questions is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)
| proportion of participants | Drug: IX-01 | Placebo |
|---|---|---|
| Proportion of Participants With ≥ 2 Category Increase in Control and ≥ 1 Category Decrease in Personal Distress on a Patient Reported Outcome (PRO) Measure | 0.17 | 0 |
'Baseline' time period defined as Day -28 - Day 0. 'Last 4 Weeks' time period defined as the 28 days prior to last time subject took study drug and after Day 14. Analysis excludes two subjects from ITT population: #010-012 (placebo) and #888-018 (active). Adjusted for treatment, baseline IELT, baseline percentage, country and site.
| percentage of attempts | Drug: IX-01 | Placebo |
|---|---|---|
| Change in Percentage of Intercourse Attempts Lasting Longer Than 1 Minute From Baseline to Last 4 Weeks on Treatment | 37.6 (17.8 to 57.3) | 13.5 (-9.1 to 36.2) |
Number of participants with at least one treatment-emergent adverse event
| participants | Drug: IX-01 | Placebo |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events | 12 | 9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Drug: IX-01 | — | 0/56 (0%) | 12/56 (21.4%) |
| Placebo | — | 0/30 (0%) | 9/30 (30%) |
| Event | Drug: IX-01 | Placebo |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 1/56 | 2/30 |
| NauseaGastrointestinal disorders | 2/56 | 1/30 |
| Ear PainEar and labyrinth disorders | 0/56 | 1/30 |
| Dry MouthGastrointestinal disorders | 1/56 | 1/30 |
| DyspepsiaGastrointestinal disorders | 0/56 | 1/30 |
| HemorrhoidsGastrointestinal disorders | 0/56 | 1/30 |
| Feeling jitteryGeneral disorders | 0/56 | 1/30 |
| Lower respiratory tract infectionInfections and infestations | 0/56 | 1/30 |
| Tooth abscessInfections and infestations | 0/56 | 1/30 |
| LacerationsInjury, poisoning and procedural complications | 0/56 | 1/30 |
| Age, Continuous(years) | Drug: IX-01 | Placebo | Total |
|---|---|---|---|
| Mean | 42 ± 9 | 43 ± 8 | 43 ± 9 |
| Sex: Female, Male(Participants) | Drug: IX-01 | Placebo | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 58 | 30 | 88 |
| Ethnicity (NIH/OMB)(Participants) | Drug: IX-01 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 2 | 12 |
| Not Hispanic or Latino | 48 | 28 | 76 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Drug: IX-01 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 2 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 5 | 11 |
| White | 48 | 21 | 69 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Drug: IX-01 | Placebo | Total |
|---|---|---|---|
| United States | 47 | 23 | 70 |
| Australia | 11 | 7 | 18 |
The record gives a start of Sep 2014, a primary completion of Oct 2015 and a completion of Oct 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2019, 3 years 3 months after primary completion. A results delay was requested in Sep 2016.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: IX-01
Ixchelsis Limited