Premature Ejaculation
Conditions
Keywords
Sex, Sexual Dysfunction, IX-01
Brief summary
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.
Interventions
DRUGIX-01 400 mg
IX-01 400 mg caplet
DRUGPlacebo
Placebo caplet(s)
DRUGIX-01 800 mg
IX-01 800 mg (Two 400 mg caplets)
DRUGIX-01 1200 mg
IX-01 1200 mg (Three 400 mg caplets)
Sponsors
Ixchelsis Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Men aged ≥18 years and ≤60 years in stable (≥6 months) heterosexual relationship and who have lifelong PE. 2. Premature ejaculation ≤1 minute on ≥75% attempts at sexual intercourse during the run-in period. 3. Meets other aspects of ISSM definition. 4. Patient and partner willing to attempt intercourse at least 4 times during the run-in period and at least 8 additional times during the double-blind part of the study. 5. Partner not planning pregnancy and willing to use contraception (unless not of childbearing potential, e.g, surgically sterilized). 6. Willing to limit use of alcohol on days in which he takes study drug. 7. Capable of giving written informed consent.
Exclusion criteria
1. IELT value \>2 minutes during the run-in period. 2. \<4 attempts at sexual intercourse during the run-in period. 3. Any patient who rates his control of ejaculation as fair, good, or very good. 4. Any patient who rates his ejaculation-related personal distress as not at all or a little bit. 5. Erectile Dysfunction. 6. Concomitant use of phosphodiesterase type 5 (PDE5) inhibitors, selective serotonin reuptake inhibitor (SSRIs)/selective serotonin norepinephrine reuptake inhibitor (SSNRIs), monoamine oxidase inhibitors, alpha blockers, 5-alpha reductase inhibitors, topical anesthetics, and/or tramadol. 7. History (last 6 months) of use of Botox or similar product to treat PE. 8. Has received IX-01 in a previous clinical study. 9. Unwilling to stop other treatments for PE (including but not limited to pharmacological, sex therapy, psychotherapy multiple condoms, and prior masturbation). 10. Any other sexual disorder of patient or partner that could interfere with results. 11. Any current sexually transmitted disease. 12. Any major medical condition of patient that could interfere with ability to have sexual activity and/or require hospital treatment. 13. Body mass index (BMI) \>40 kg/m2 or weight \<60 kg. 14. Participation in a clinical drug study anytime during the 30 days prior to screening. 15. Human immunodeficiency virus (HIV), hepatitis B. 16. History of prostate disease or clinically significant prostate disease. 17. History of myocardial infarction, coronary bypass surgery, coronary artery angioplasty, unstable angina, clinically evident congestive heart failure, cardiac pacemaker, or cerebrovascular accident. 18. Known or suspected history of significant cardiac arrhythmias. 19. History of drug-induced allergic reactions including skin reactions. 20. Significant psychiatric disease and/or risk of suicidal tendency. 21. History of or other evidence of recent alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period | Last 4 weeks of treatment compared to baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Last 4 weeks of treatment compared to 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. |
| Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire | Baseline to the end of treatment (approximately 8 weeks) | 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 Patients Achieving Mean Change in Category of ≥1 or ≥2 on Control of Timing of Ejaculation on the Premature Ejaculation Profile (PEP) Questionnaire. | Baseline to the end of treatment (approximately 8 weeks) | 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'. |
| Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline | Last 4 weeks of treatment compared to 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. |
| 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 | Baseline to the end of treatment (approximately 8 weeks) | 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). |
| Mean Change From Baseline in Score on Control of Ejaculation | Last 4 weeks of treatment compared to baseline | 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). |
| Mean Change From Baseline in Score on Ejaculation-related Personal Distress | Last 4 weeks of treatment compared to baseline | Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement. |
| Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 in Ejaculation-related Personal Distress on the Premature Ejaculation Profile (PEP) Questionnaire | Baseline to the end of treatment (approximately 8 weeks) | 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'. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity | 46 |
| IX-01 400 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 | 48 |
| IX-01 800 mg 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 | 68 |
| IX-01 1200 mg 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 | 69 |
| Total | 231 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 3 | 6 | 7 |
| Overall Study | Partner not willing to try intercourse | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal of consent to continue drug | 1 | 1 | 2 | 0 |
| Overall Study | Withdrawal of consent to continue study | 2 | 3 | 4 | 6 |
Baseline characteristics
| Characteristic | Total | IX-01 1200 mg | IX-01 800 mg | IX-01 400 mg | Placebo |
|---|---|---|---|---|---|
| Age, Continuous | 41.6 years STANDARD_DEVIATION 9.29 | 43.8 years STANDARD_DEVIATION 8.63 | 40.1 years STANDARD_DEVIATION 9.78 | 41.8 years STANDARD_DEVIATION 9.28 | 40.2 years STANDARD_DEVIATION 9.13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 42 Participants | 19 Participants | 11 Participants | 5 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 189 Participants | 50 Participants | 57 Participants | 43 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 7 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black or African American | 27 Participants | 8 Participants | 7 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 6 Participants | 2 Participants | 0 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 190 Participants | 57 Participants | 58 Participants | 35 Participants | 40 Participants |
| Region of Enrollment United States | 231 participants | 69 participants | 68 participants | 48 participants | 46 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 231 Participants | 69 Participants | 68 Participants | 48 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 48 | 0 / 68 | 0 / 69 |
| other Total, other adverse events | 12 / 46 | 8 / 48 | 12 / 68 | 18 / 69 |
| serious Total, serious adverse events | 0 / 46 | 0 / 48 | 0 / 68 | 0 / 69 |
Outcome results
Primary
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
Population: Results presented for modified Intent to treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period | 42.6 Seconds | Standard Error 10.9 |
| IX-01 400 mg | Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period | 39.7 Seconds | Standard Error 10.6 |
| IX-01 800 mg | Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period | 44.5 Seconds | Standard Error 9 |
| IX-01 1200 mg | Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period | 29.2 Seconds | Standard Error 9.1 |
Secondary
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
Population: Results presented for modified Intent to treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline | 1.77 Fold change | Standard Error 0.11 |
| IX-01 400 mg | Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline | 1.56 Fold change | Standard Error 0.11 |
| IX-01 800 mg | Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline | 1.79 Fold change | Standard Error 0.09 |
| IX-01 1200 mg | Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline | 1.54 Fold change | Standard Error 0.09 |
Secondary
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
Population: Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Score on Control of Ejaculation | 0.55 score on a scale | Standard Deviation 0.938 |
| IX-01 400 mg | Mean Change From Baseline in Score on Control of Ejaculation | 0.46 score on a scale | Standard Deviation 0.837 |
| IX-01 800 mg | Mean Change From Baseline in Score on Control of Ejaculation | 0.58 score on a scale | Standard Deviation 0.868 |
| IX-01 1200 mg | Mean Change From Baseline in Score on Control of Ejaculation | 0.32 score on a scale | Standard Deviation 0.619 |
Secondary
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
Population: Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Score on Ejaculation-related Personal Distress | 0.73 score on a scale | Standard Deviation 1.139 |
| IX-01 400 mg | Mean Change From Baseline in Score on Ejaculation-related Personal Distress | 0.38 score on a scale | Standard Deviation 1.036 |
| IX-01 800 mg | Mean Change From Baseline in Score on Ejaculation-related Personal Distress | 0.58 score on a scale | Standard Deviation 0.933 |
| IX-01 1200 mg | Mean Change From Baseline in Score on Ejaculation-related Personal Distress | 0.51 score on a scale | Standard Deviation 0.898 |
Secondary
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)
Population: Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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 Proportion of participants |
| IX-01 400 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 | 0.11 Proportion of participants |
| IX-01 800 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 | 0.25 Proportion of participants |
| 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 | 0.08 Proportion of participants |
Secondary
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)
Population: Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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 Proportion of participants |
| IX-01 400 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 | 0.25 Proportion of participants |
| IX-01 800 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 | 0.39 Proportion of participants |
| 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 | 0.23 Proportion of participants |
Secondary
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)
Population: Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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 Proportion of participants |
| IX-01 400 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. | 0.18 Proportion of participants |
| IX-01 800 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. | 0.33 Proportion of participants |
| 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. | 0.18 Proportion of participants |
Secondary
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)
Population: Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire | Better | 0.12 Proportion of participants |
| Placebo | Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire | Much better | 0 Proportion of participants |
| IX-01 400 mg | Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire | Much better | 0.02 Proportion of participants |
| IX-01 400 mg | Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire | Better | 0.05 Proportion of participants |
| IX-01 800 mg | Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire | Better | 0.07 Proportion of participants |
| IX-01 800 mg | Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire | Much better | 0.12 Proportion of participants |
| IX-01 1200 mg | Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire | Better | 0.07 Proportion of participants |
| IX-01 1200 mg | Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire | Much better | 0 Proportion of participants |
Secondary
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
Population: Results presented for modified Intent to treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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 Proportion of participants |
| IX-01 400 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 | 0.20 Proportion of participants |
| IX-01 800 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 | 0.26 Proportion of participants |
| 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 | 0.20 Proportion of participants |