Trial · NCT02232425

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

NCT02232425, Phase 2, Completed, Ixchelsis Limited; results first posted 2019-01-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE). Trials, record NCT02232425. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02232425

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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) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)
NCT number: NCT02232425
Status: Completed
Phases: Phase 2
Enrollment: 88 participants, actual
Lead sponsor: Ixchelsis Limited
Conditions: Premature Ejaculation
Interventions: IX-01, Placebo
First posted: 2014-09-05
Last updated: 2020-08-17
Results first posted: 2019-01-24

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)	Last 4 weeks of treatment compared to baseline	IX-01 versus placebo. Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred
Secondary	Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale	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 7 point scale
Secondary	Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT)	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. 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
Secondary	Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time)	Last 4 weeks of treatment compared to baseline	IX-01 versus placebo
Secondary	Mean Change in Score on Control of Timing 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 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.
Secondary	Proportion of Participants With ≥ 1 Category of Improvement in Satisfaction With Sexual Intercourse, on the Premature Ejaculation Profile (PEP) Questionnaire	Baseline to 8 weeks	Based on Premature Ejaculation Profile (PEP) 5 point scale with the scores ranging from 0 (worse answer) to 4 (best answer).
Secondary	Proportion of Participants With ≥ 1 Category of Improvement in Control Over Ejaculation During Sexual Intercourse on the Premature Ejaculation Profile (PEP) Questionnaire	Baseline to 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	Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Distress on the Premature Ejaculation Profile ( PEP) Questionnaire	Baseline to 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.
Secondary	Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Interpersonal Difficulty on the Premature Ejaculation Profile (PEP) Questionnaire	Baseline to 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.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)	Last 4 weeks of treatment compared to baseline	Efficacy data set excluding outliers	No units for fold change	GEOMETRIC_MEAN
SECONDARY	Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale	Baseline to the end of treatment (approximately 8 weeks)	Intent to treat, excluding outliers	proportion of participants	NUMBER
SECONDARY	Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT)	Last 4 weeks of treatment compared to baseline	Intent to treat, excluding outliers	Proportion of participants	NUMBER
SECONDARY	Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time)	Last 4 weeks of treatment compared to baseline	Intent to treat, excluding outliers	No units for fold change	MEAN
SECONDARY	Mean Change in Score on Control of Timing of Ejaculation	Last 4 weeks of treatment compared to baseline	Intent to treat, excluding outliers	units on a scale	MEAN
SECONDARY	Mean Change in Score on Ejaculation-related Personal Distress	Last 4 weeks of treatment compared to baseline	Intent to treat, excluding outliers	units on a scale	MEAN
SECONDARY	Proportion of Participants With ≥ 1 Category of Improvement in Satisfaction With Sexual Intercourse, on the Premature Ejaculation Profile (PEP) Questionnaire	Baseline to 8 weeks	Intent to treat, excluding outliers	adjusted proportion of participants	NUMBER
SECONDARY	Proportion of Participants With ≥ 1 Category of Improvement in Control Over Ejaculation During Sexual Intercourse on the Premature Ejaculation Profile (PEP) Questionnaire	Baseline to 8 weeks	Intent to treat, excluding outliers	adjusted proportion of participants	NUMBER
SECONDARY	Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Distress on the Premature Ejaculation Profile ( PEP) Questionnaire	Baseline to 8 weeks	Intent to treat, excluding outliers	adjusted proportion of participants	NUMBER
SECONDARY	Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Interpersonal Difficulty on the Premature Ejaculation Profile (PEP) Questionnaire	Baseline to 8 weeks	Intent to treat, excluding outliers	adjusted proportion of participants	NUMBER

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group28

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

Outcome	Group	Category	Value	Spread	Units
Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)	Drug: IX-01		2.1	95% Confidence Interval 1.5 to 3.1	No units for fold change
Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)	Placebo		1.1	95% Confidence Interval 0.7 to 1.8	No units for fold change
Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale	Drug: IX-01	Better/Much Better	0.17		proportion of participants
Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale	Placebo	Better/Much Better	0		proportion of participants
Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale	Drug: IX-01	Any Improvement	0.44		proportion of participants
Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale	Placebo	Any Improvement	0.13		proportion of participants
Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT)	Drug: IX-01		0.31	95% Confidence Interval 0.14 to 0.54	Proportion of participants
Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT)	Placebo		0.07	95% Confidence Interval 0.01 to 0.32	Proportion of participants
Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time)	Drug: IX-01		3.6	95% Confidence Interval 2.2 to 5.0	No units for fold change
Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time)	Placebo		1.8	95% Confidence Interval 0.9 to 2.7	No units for fold change

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Drug: IX-01	58
Overall Study	STARTED	Placebo	30
Overall Study	COMPLETED	Drug: IX-01	44
Overall Study	COMPLETED	Placebo	22
Overall Study	NOT COMPLETED	Drug: IX-01	14
Overall Study	NOT COMPLETED	Placebo	8

Source ClinicalTrials.gov

Adverse events48

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	Ear Pain	Ear and labyrinth disorders	Drug: IX-01	0	56
other	Ear Pain	Ear and labyrinth disorders	Placebo	1	30
other	Nausea	Gastrointestinal disorders	Drug: IX-01	2	56
other	Nausea	Gastrointestinal disorders	Placebo	1	30
other	Dry Mouth	Gastrointestinal disorders	Drug: IX-01	1	56
other	Dry Mouth	Gastrointestinal disorders	Placebo	1	30
other	Dental caries	Gastrointestinal disorders	Drug: IX-01	1	56
other	Dental caries	Gastrointestinal disorders	Placebo	0	30
other	Diarrhea	Gastrointestinal disorders	Drug: IX-01	1	56
other	Diarrhea	Gastrointestinal disorders	Placebo	0	30

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Drug: IX-01
Total, all-cause mortality	Placebo
Total, other adverse events	Drug: IX-01	12	56
Total, other adverse events	Placebo	9	30
Total, serious adverse events	Drug: IX-01	0	56
Total, serious adverse events	Placebo	0	30

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31351659	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 comparisons2

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

Comparison	Source
Drug: IX-01 vs Placebo: Incidence of Treatment-emergent Adverse Events	Trial comparisons
Drug: IX-01 vs Placebo: serious adverse events	Trial comparisons

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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