A Phase 2 interventional study of IX-01 400 mg and Placebo in Premature Ejaculation, sponsored by Ixchelsis Limited. Completed at 29 sites in United States. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-10-07.
Sponsored by Ixchelsis Limited · Phase 2, Interventional, and Treatment
A Phase 2b, 8-week, double-blind, placebo-controlled, parallel group study to evaluate the effect of 3 different dose levels of IX-01 on IELT and patient-reported outcome in men with lifelong PE.
Men with self-reported lifelong PE (International Society for Sexual Medicine (ISSM) definition) and in stable heterosexual relationship will undergo a 4-week run-in period during which they will be asked to attempt intercourse at least 4 times. Men with IELT ≤ 1 minute on at least 75% of attempts at intercourse during the no-treatment run-in period will be randomized for the double-blind phase of the study.
In the double-blind phase of the study, men will be asked to take study drug 1 to 6 hours prior to sexual activity. Men and partners will be asked to attempt intercourse a minimum of 8 times during the 8 week double-blind study treatment. The patient or partner will record the IELT on each occasion by use of a stopwatch.
106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
This study's enrollment of 239 is above 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.
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.
1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Drug: IX-01 1200 mg
Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Drug: Placebo
800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Drug: Placebo · Drug: IX-01 800 mg
400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Drug: IX-01 400 mg · Drug: Placebo
IX-01 400 mg caplet
Placebo caplet(s)
IX-01 800 mg (Two 400 mg caplets)
IX-01 1200 mg (Three 400 mg caplets)
Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period
Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was recorded by the patient or partner using the stopwatch provided.
Time frame: Last 4 weeks of treatment compared to baseline
Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline
Intravaginal Ejaculatory Latency Time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was recorded using the stopwatch provided.
Time frame: Last 4 weeks of treatment compared to baseline
Proportion of Patients With ≥2.5-fold Increase in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period Compared With Baseline
Intravaginal Ejaculatory Latency Time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was measured using the stopwatch provided.
Time frame: Last 4 weeks of treatment compared to baseline
Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire
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 scale.
Time frame: Baseline to the end of treatment (approximately 8 weeks)
Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 on Control of Timing of Ejaculation 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). A mean change in category of ≥1 or ≥2 corresponds to improving control from 'very poor' to 'fair', 'good', or 'very good'; or from 'poor' to 'fair', 'good', or 'very good'.
Time frame: Baseline to the end of treatment (approximately 8 weeks)
Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 in Ejaculation-related Personal 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. A change in category of ≥1 or ≥2 corresponds to improving distress from 'extremely' to 'moderately', 'a little bit' or 'not at all'; or from 'quite a bit' to 'moderately', 'a little bit' or 'not at all'; or from 'moderately' to 'a little bit' or 'not at all'.
Time frame: Baseline to the end of treatment (approximately 8 weeks)
Proportion of Patients Achieving Change in Category of ≥2 on Control of Timing of Ejaculation and Achieving Change in Category of ≥1 in Ejaculation-related Personal Distress at End of Treatment
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 the end of treatment (approximately 8 weeks)
Mean Change From Baseline in Score on Control 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 From Baseline 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
| Milestone | Placebo | IX-01 400 mg | IX-01 800 mg | IX-01 1200 mg |
|---|---|---|---|---|
| Started | 48 | 48 | 71 | 72 |
| Completed | 42 | 41 | 58 | 57 |
| Not completed | 6 | 7 | 13 | 15 |
| Withdrew: Adverse event | 0 | 0 | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 3 | 6 | 7 |
| Withdrew: Physician decision | 1 | 0 | 0 | 1 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal of consent to continue drug | 1 | 1 | 2 | 0 |
| Withdrew: Withdrawal of consent to continue study | 2 | 3 | 4 | 6 |
| Withdrew: Partner not willing to try intercourse | 1 | 0 | 0 | 0 |
Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was recorded by the patient or partner using the stopwatch provided.
| Seconds | Placebo | IX-01 400 mg | IX-01 800 mg | IX-01 1200 mg |
|---|---|---|---|---|
| Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period | 42.6 ± 10.9 | 39.7 ± 10.6 | 44.5 ± 9.0 | 29.2 ± 9.1 |
Intravaginal Ejaculatory Latency Time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was recorded using the stopwatch provided.
| Fold change | Placebo | IX-01 400 mg | IX-01 800 mg | IX-01 1200 mg |
|---|---|---|---|---|
| Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline | 1.77 ± 0.11 | 1.56 ± 0.11 | 1.79 ± 0.09 | 1.54 ± 0.09 |
Intravaginal Ejaculatory Latency Time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was measured using the stopwatch provided.
| Proportion of participants | Placebo | IX-01 400 mg | IX-01 800 mg | IX-01 1200 mg |
|---|---|---|---|---|
| Proportion of Patients With ≥2.5-fold Increase in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period Compared With Baseline | 0.30 | 0.20 | 0.26 | 0.20 |
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 scale.
| Proportion of participants | Placebo | IX-01 400 mg | IX-01 800 mg | IX-01 1200 mg |
|---|---|---|---|---|
| Better | 0.12 | 0.05 | 0.07 | 0.07 |
| Much better | 0 | 0.02 | 0.12 | 0 |
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). A mean change in category of ≥1 or ≥2 corresponds to improving control from 'very poor' to 'fair', 'good', or 'very good'; or from 'poor' to 'fair', 'good', or 'very good'.
| Proportion of participants | Placebo | IX-01 400 mg | IX-01 800 mg | IX-01 1200 mg |
|---|---|---|---|---|
| Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 on Control of Timing of Ejaculation on the Premature Ejaculation Profile (PEP) Questionnaire. | 0.35 | 0.18 | 0.33 | 0.18 |
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. A change in category of ≥1 or ≥2 corresponds to improving distress from 'extremely' to 'moderately', 'a little bit' or 'not at all'; or from 'quite a bit' to 'moderately', 'a little bit' or 'not at all'; or from 'moderately' to 'a little bit' or 'not at all'.
| Proportion of participants | Placebo | IX-01 400 mg | IX-01 800 mg | IX-01 1200 mg |
|---|---|---|---|---|
| Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 in Ejaculation-related Personal Distress on the Premature Ejaculation Profile (PEP) Questionnaire | 0.37 | 0.25 | 0.39 | 0.23 |
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).
| Proportion of participants | Placebo | IX-01 400 mg | IX-01 800 mg | IX-01 1200 mg |
|---|---|---|---|---|
| Proportion of Patients Achieving Change in Category of ≥2 on Control of Timing of Ejaculation and Achieving Change in Category of ≥1 in Ejaculation-related Personal Distress at End of Treatment | 0.13 | 0.11 | 0.25 | 0.08 |
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).
| score on a scale | Placebo | IX-01 400 mg | IX-01 800 mg | IX-01 1200 mg |
|---|---|---|---|---|
| Mean Change From Baseline in Score on Control of Ejaculation | 0.55 ± 0.938 | 0.46 ± 0.837 | 0.58 ± 0.868 | 0.32 ± 0.619 |
Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.
| score on a scale | Placebo | IX-01 400 mg | IX-01 800 mg | IX-01 1200 mg |
|---|---|---|---|---|
| Mean Change From Baseline in Score on Ejaculation-related Personal Distress | 0.73 ± 1.139 | 0.38 ± 1.036 | 0.58 ± 0.933 | 0.51 ± 0.898 |
Collected over Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/46 (0%) | 0/46 (0%) | 12/46 (26.1%) |
| IX-01 400 mg | 0/48 (0%) | 0/48 (0%) | 8/48 (16.7%) |
| IX-01 800 mg | 0/68 (0%) | 0/68 (0%) | 12/68 (17.6%) |
| IX-01 1200 mg | 0/69 (0%) | 0/69 (0%) | 18/69 (26.1%) |
| Event | Placebo | IX-01 400 mg | IX-01 800 mg | IX-01 1200 mg |
|---|---|---|---|---|
| HeadacheNervous system disorders | 3/46 | 2/48 | 2/68 | 2/69 |
| Upper respiratory tract infectionInfections and infestations | 2/46 | 0/48 | 1/68 | 0/69 |
| NasopharyngitisInfections and infestations | 1/46 | 1/48 | 1/68 | 2/69 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/46 | 0/48 | 0/68 | 2/69 |
| ParosmiaNervous system disorders | 1/46 | 0/48 | 0/68 | 0/69 |
| Abnormal dreamsPsychiatric disorders | 1/46 | 0/48 | 0/68 | 1/69 |
| Depressed moodPsychiatric disorders | 1/46 | 0/48 | 0/68 | 0/69 |
| Blood pressure increasedInvestigations | 1/46 | 0/48 | 0/68 | 0/69 |
| ConcussionInjury, poisoning and procedural complications | 1/46 | 0/48 | 0/68 | 0/69 |
| Skin abrasionInjury, poisoning and procedural complications | 1/46 | 0/48 | 0/68 | 0/69 |
| Age, Continuous(years) | Placebo | IX-01 400 mg | IX-01 800 mg | IX-01 1200 mg | Total |
|---|---|---|---|---|---|
| Mean | 40.2 ± 9.13 | 41.8 ± 9.28 | 40.1 ± 9.78 | 43.8 ± 8.63 | 41.6 ± 9.29 |
| Sex: Female, Male(Participants) | Placebo | IX-01 400 mg | IX-01 800 mg | IX-01 1200 mg | Total |
|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 |
| Male | 46 | 48 | 68 | 69 | 231 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | IX-01 400 mg | IX-01 800 mg | IX-01 1200 mg | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 7 | 5 | 11 | 19 | 42 |
| Not Hispanic or Latino | 39 | 43 | 57 | 50 | 189 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Placebo | IX-01 400 mg | IX-01 800 mg | IX-01 1200 mg | Total |
|---|---|---|---|---|---|
| Race — White | 40 | 35 | 58 | 57 | 190 |
| Race — Black or African American | 4 | 8 | 7 | 8 | 27 |
| Race — Asian | 1 | 2 | 2 | 2 | 7 |
| Race — American Indian or Alaska Native | 0 | 0 | 1 | 0 | 1 |
| Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Race — Other | 1 | 3 | 0 | 2 | 6 |
| Region of Enrollment(participants) | Placebo | IX-01 400 mg | IX-01 800 mg | IX-01 1200 mg | Total |
|---|---|---|---|---|---|
| United States | 46 | 48 | 68 | 69 | 231 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: IX-01
Ixchelsis Limited