Trial · NCT03055806

IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)

NCT03055806, Phase 2, Completed, Ixchelsis Limited; results first posted 2019-10-07

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE). Trials, record NCT03055806. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03055806

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)
NCT number: NCT03055806
Status: Completed
Phases: Phase 2
Enrollment: 239 participants, actual
Lead sponsor: Ixchelsis Limited
Conditions: Premature Ejaculation
Interventions: IX-01 400 mg, Placebo, IX-01 800 mg, IX-01 1200 mg
First posted: 2017-02-16
Last updated: 2019-10-07
Results first posted: 2019-10-07

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.
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	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.
Secondary	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.
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.	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'.
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	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'.
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	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).
Secondary	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).
Secondary	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.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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	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).	Seconds	LEAST_SQUARES_MEAN
SECONDARY	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	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).	Fold change	LEAST_SQUARES_MEAN
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	Last 4 weeks of treatment compared to baseline	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).	Proportion of participants	NUMBER
SECONDARY	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)	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).	Proportion of participants	NUMBER
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.	Baseline to the end of treatment (approximately 8 weeks)	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).	Proportion of participants	NUMBER
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	Baseline to the end of treatment (approximately 8 weeks)	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).	Proportion of participants	NUMBER
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	Baseline to the end of treatment (approximately 8 weeks)	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).	Proportion of participants	NUMBER
SECONDARY	Mean Change From Baseline in Score on Control of Ejaculation	Last 4 weeks of treatment compared to baseline	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).	score on a scale	MEAN
SECONDARY	Mean Change From Baseline in Score on Ejaculation-related Personal Distress	Last 4 weeks of treatment compared to baseline	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).	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period	Placebo	42.6	Standard Error 10.9	Seconds
Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period	IX-01 400 mg	39.7	Standard Error 10.6	Seconds
Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period	IX-01 800 mg	44.5	Standard Error 9.0	Seconds
Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period	IX-01 1200 mg	29.2	Standard Error 9.1	Seconds
Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline	Placebo	1.77	Standard Error 0.11	Fold change
Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline	IX-01 400 mg	1.56	Standard Error 0.11	Fold change
Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline	IX-01 800 mg	1.79	Standard Error 0.09	Fold change
Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline	IX-01 1200 mg	1.54	Standard Error 0.09	Fold change
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	Placebo	0.30		Proportion of participants
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	IX-01 400 mg	0.20		Proportion of participants

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	48
Overall Study	STARTED	IX-01 400 mg	48
Overall Study	STARTED	IX-01 800 mg	71
Overall Study	STARTED	IX-01 1200 mg	72
Overall Study	COMPLETED	Placebo	42
Overall Study	COMPLETED	IX-01 400 mg	41
Overall Study	COMPLETED	IX-01 800 mg	58
Overall Study	COMPLETED	IX-01 1200 mg	57
Overall Study	NOT COMPLETED	Placebo	6
Overall Study	NOT COMPLETED	IX-01 400 mg	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events212

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Dizziness	Nervous system disorders	Placebo	0	46
other	Dizziness	Nervous system disorders	IX-01 400 mg	0	48
other	Dizziness	Nervous system disorders	IX-01 800 mg	0	68
other	Dizziness	Nervous system disorders	IX-01 1200 mg	1	69
other	Headache	Nervous system disorders	Placebo	3	46
other	Headache	Nervous system disorders	IX-01 400 mg	2	48
other	Headache	Nervous system disorders	IX-01 800 mg	2	68
other	Headache	Nervous system disorders	IX-01 1200 mg	2	69
other	Hypersomnia	Nervous system disorders	Placebo	0	46
other	Hypersomnia	Nervous system disorders	IX-01 400 mg	0	48

1 to 10 of 212Source ClinicalTrials.gov

See all 212 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	46
Total, all-cause mortality	IX-01 400 mg	0	48
Total, all-cause mortality	IX-01 800 mg	0	68
Total, all-cause mortality	IX-01 1200 mg	0	69
Total, other adverse events	Placebo	12	46
Total, other adverse events	IX-01 400 mg	8	48
Total, other adverse events	IX-01 800 mg	12	68
Total, other adverse events	IX-01 1200 mg	18	69
Total, serious adverse events	Placebo	0	46
Total, serious adverse events	IX-01 400 mg	0	48

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31351660	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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