NCT03055806

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

Completed Phase 2 Results posted Last updated 7 October 2019

What this trial tests

Phase 2 trial testing IX-01 400 mg in Premature Ejaculation in 239 participants. Completed in 6 December 2017.

Timeline

28 February 2017

Primary endpoint
17 November 2017

6 December 2017

Quick facts

Lead sponsor	Ixchelsis Limited
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	239
Start date	28 February 2017
Primary completion	17 November 2017
Estimated completion	6 December 2017
Sites	29 locations across United States

Drugs / interventions tested

• IX-01 400 mg — full drug profile →
• Placebo
• IX-01 800 mg — full drug profile →
• IX-01 1200 mg — full drug profile →

Conditions studied

• Premature Ejaculation — all drugs for Premature Ejaculation →

Sponsor

Ixchelsis Limited — full company profile →

Who can join

Adults 18 to 60, male only, with Premature Ejaculation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period Primary · 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.

Group	Value	95% CI
Placebo	42.6	± 10.9
IX-01 400 mg	39.7	± 10.6
IX-01 800 mg	44.5	± 9.0
IX-01 1200 mg	29.2	± 9.1

Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline Secondary · 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.

Group	Value	95% CI
Placebo	1.77	± 0.11
IX-01 400 mg	1.56	± 0.11
IX-01 800 mg	1.79	± 0.09
IX-01 1200 mg	1.54	± 0.09

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 Secondary · 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.

Group	Value	95% CI
Placebo	0.30
IX-01 400 mg	0.20
IX-01 800 mg	0.26
IX-01 1200 mg	0.20

Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire Secondary · 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.

Better

Group	Value	95% CI
Placebo	0.12
IX-01 400 mg	0.05
IX-01 800 mg	0.07
IX-01 1200 mg	0.07

Much better

Group	Value	95% CI
Placebo	0
IX-01 400 mg	0.02
IX-01 800 mg	0.12
IX-01 1200 mg	0

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. Secondary · 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'.

Group	Value	95% CI
Placebo	0.35
IX-01 400 mg	0.18
IX-01 800 mg	0.33
IX-01 1200 mg	0.18

Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 in Ejaculation-related Personal Distress on the Premature Ejaculation Profile (PEP) Questionnaire Secondary · 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'.

Group	Value	95% CI
Placebo	0.37
IX-01 400 mg	0.25
IX-01 800 mg	0.39
IX-01 1200 mg	0.23

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 Secondary · 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).

Group	Value	95% CI
Placebo	0.13
IX-01 400 mg	0.11
IX-01 800 mg	0.25
IX-01 1200 mg	0.08

Mean Change From Baseline in Score on Control of Ejaculation Secondary · 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).

Group	Value	95% CI
Placebo	0.55	± 0.938
IX-01 400 mg	0.46	± 0.837
IX-01 800 mg	0.58	± 0.868
IX-01 1200 mg	0.32	± 0.619

Mean Change From Baseline in Score on Ejaculation-related Personal Distress Secondary · 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.

Group	Value	95% CI
Placebo	0.73	± 1.139
IX-01 400 mg	0.38	± 1.036
IX-01 800 mg	0.58	± 0.933
IX-01 1200 mg	0.51	± 0.898

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/46 (0%)

Deaths: 0/46

IX-01 400 mg

Serious: 0/48 (0%)

Deaths: 0/48

IX-01 800 mg

Serious: 0/68 (0%)

Deaths: 0/68

IX-01 1200 mg

Serious: 0/69 (0%)

Deaths: 0/69

Other adverse events (53 terms — click to expand)

Reaction	System	Placebo	IX-01 400 mg	IX-01 800 mg	IX-01 1200 mg
Headache	Nervous system disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Hypersomnia	Nervous system disorders	—	—	—	—
Memory impairment	Nervous system disorders	—	—	—	—
Parosmia	Nervous system disorders	—	—	—	—
Poor quality sleep	Nervous system disorders	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—
Tinea cruris	Infections and infestations	—	—	—	—
Abnormal dreams	Psychiatric disorders	—	—	—	—
Depressed mood	Psychiatric disorders	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Libido decreased	Psychiatric disorders	—	—	—	—
Libido increased	Psychiatric disorders	—	—	—	—
Blood potassium increased	Investigations	—	—	—	—
Blood pressure increased	Investigations	—	—	—	—
Haematocrit increased	Investigations	—	—	—	—
Neutrophil count increased	Investigations	—	—	—	—
Red blood cell count increased	Investigations	—	—	—	—
Red blood cells urine positive	Investigations	—	—	—	—
Weight decreased	Investigations	—	—	—	—
White blood cell count increased	Investigations	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Faeces discoloured	Gastrointestinal disorders	—	—	—	—
Concussion	Injury, poisoning and procedural complications	—	—	—	—
Laceration	Injury, poisoning and procedural complications	—	—	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—	—	—
Skin abrasion	Injury, poisoning and procedural complications	—	—	—	—
Stress fracture	Injury, poisoning and procedural complications	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Joint hyperextension	Musculoskeletal and connective tissue disorders	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—

Data from ClinicalTrials.gov NCT03055806 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.