Trial Outcomes & Findings for IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE) (NCT NCT02232425)

NCT ID: NCT02232425

Last Updated: 2020-08-17

Results Overview

IX-01 versus placebo. Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 88 participants
• Primary outcome timeframe: Last 4 weeks of treatment compared to baseline
• Results posted on: 2020-08-17

Participant Flow

Participant milestones

Measure	Drug: IX-01 Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity IX-01	Placebo Two to four capsules administered orally, 1-6 hours prior to sexual activity Placebo
Overall Study STARTED	58	30
Overall Study COMPLETED	44	22
Overall Study NOT COMPLETED	14	8

Reasons for withdrawal

Measure	Drug: IX-01 Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity IX-01	Placebo Two to four capsules administered orally, 1-6 hours prior to sexual activity Placebo
Overall Study Lost to Follow-up	6	2
Overall Study Adverse Event	2	0
Overall Study Withdrawal by Subject	5	6
Overall Study Lack of Efficacy	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Drug: IX-01 n=58 Participants Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity IX-01	Placebo n=30 Participants Two to four capsules administered orally, 1-6 hours prior to sexual activity Placebo	Total n=88 Participants Total of all reporting groups
Age, Continuous	42 years STANDARD_DEVIATION 9 • n=5 Participants	43 years STANDARD_DEVIATION 8 • n=7 Participants	43 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	30 Participants n=7 Participants	88 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=5 Participants	28 Participants n=7 Participants	76 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants	21 Participants n=7 Participants	69 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants	23 participants n=7 Participants	70 participants n=5 Participants
Region of Enrollment Australia	11 participants n=5 Participants	7 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Last 4 weeks of treatment compared to baseline

Population: Efficacy data set excluding outliers

IX-01 versus placebo. Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred

Outcome measures

Measure	Drug: IX-01 n=54 Participants Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity IX-01	Placebo n=25 Participants Two to four capsules administered orally, 1-6 hours prior to sexual activity Placebo
Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)	2.1 No units for fold change Interval 1.5 to 3.1	1.1 No units for fold change Interval 0.7 to 1.8

SECONDARY outcome

Timeframe: Baseline to the end of treatment (approximately 8 weeks)

Population: Intent to treat, excluding outliers

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

Outcome measures

Measure	Drug: IX-01 n=48 Participants Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity IX-01	Placebo n=24 Participants Two to four capsules administered orally, 1-6 hours prior to sexual activity Placebo
Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale Better/Much Better	0.17 proportion of participants	0 proportion of participants
Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale Any Improvement	0.44 proportion of participants	0.13 proportion of participants

SECONDARY outcome

Timeframe: Last 4 weeks of treatment compared to baseline

Population: Intent to treat, excluding outliers

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

Outcome measures

Measure	Drug: IX-01 n=55 Participants Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity IX-01	Placebo n=29 Participants Two to four capsules administered orally, 1-6 hours prior to sexual activity Placebo
Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT)	0.31 Proportion of participants Interval 0.14 to 0.54	0.07 Proportion of participants Interval 0.01 to 0.32

SECONDARY outcome

Timeframe: Last 4 weeks of treatment compared to baseline

Population: Intent to treat, excluding outliers

IX-01 versus placebo

Outcome measures

Measure	Drug: IX-01 n=54 Participants Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity IX-01	Placebo n=25 Participants Two to four capsules administered orally, 1-6 hours prior to sexual activity Placebo
Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time)	3.6 No units for fold change Interval 2.2 to 5.0	1.8 No units for fold change Interval 0.9 to 2.7

SECONDARY outcome

Timeframe: Last 4 weeks of treatment compared to baseline

Population: Intent to treat, excluding outliers

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)

Outcome measures

Measure	Drug: IX-01 n=54 Participants Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity IX-01	Placebo n=25 Participants Two to four capsules administered orally, 1-6 hours prior to sexual activity Placebo
Mean Change in Score on Control of Timing of Ejaculation	0.42 units on a scale Interval -0.08 to 0.93	-0.03 units on a scale Interval -0.59 to 0.53

SECONDARY outcome

Timeframe: Last 4 weeks of treatment compared to baseline

Population: Intent to treat, excluding outliers

Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.

Outcome measures

Measure	Drug: IX-01 n=54 Participants Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity IX-01	Placebo n=25 Participants Two to four capsules administered orally, 1-6 hours prior to sexual activity Placebo
Mean Change in Score on Ejaculation-related Personal Distress	0.63 units on a scale Interval 0.37 to 0.88	0.03 units on a scale Interval -0.34 to 0.4

SECONDARY outcome

Timeframe: Baseline to 8 weeks

Population: Intent to treat, excluding outliers

Based on Premature Ejaculation Profile (PEP) 5 point scale with the scores ranging from 0 (worse answer) to 4 (best answer).

Outcome measures

Measure	Drug: IX-01 n=52 Participants Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity IX-01	Placebo n=25 Participants Two to four capsules administered orally, 1-6 hours prior to sexual activity Placebo
Proportion of Participants With ≥ 1 Category of Improvement in Satisfaction With Sexual Intercourse, on the Premature Ejaculation Profile (PEP) Questionnaire	0.53 adjusted proportion of participants Interval 0.33 to 0.72	0.30 adjusted proportion of participants Interval 0.13 to 0.56

SECONDARY outcome

Timeframe: Baseline to 8 weeks

Population: Intent to treat, excluding outliers

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)

Outcome measures

Measure	Drug: IX-01 n=52 Participants Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity IX-01	Placebo n=25 Participants Two to four capsules administered orally, 1-6 hours prior to sexual activity Placebo
Proportion of Participants With ≥ 1 Category of Improvement in Control Over Ejaculation During Sexual Intercourse on the Premature Ejaculation Profile (PEP) Questionnaire	0.56 adjusted proportion of participants Interval 0.42 to 0.69	0.36 adjusted proportion of participants Interval 0.19 to 0.58

SECONDARY outcome

Timeframe: Baseline to 8 weeks

Population: Intent to treat, excluding outliers

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.

Outcome measures

Measure	Drug: IX-01 n=52 Participants Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity IX-01	Placebo n=25 Participants Two to four capsules administered orally, 1-6 hours prior to sexual activity Placebo
Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Distress on the Premature Ejaculation Profile ( PEP) Questionnaire	0.60 adjusted proportion of participants Interval 0.46 to 0.73	0.36 adjusted proportion of participants Interval 0.19 to 0.57

SECONDARY outcome

Timeframe: Baseline to 8 weeks

Population: Intent to treat, excluding outliers

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.

Outcome measures

Measure	Drug: IX-01 n=52 Participants Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity IX-01	Placebo n=25 Participants Two to four capsules administered orally, 1-6 hours prior to sexual activity Placebo
Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Interpersonal Difficulty on the Premature Ejaculation Profile (PEP) Questionnaire	0.60 adjusted proportion of participants Interval 0.45 to 0.72	0.48 adjusted proportion of participants Interval 0.29 to 0.68

SECONDARY outcome

Timeframe: Baseline to 8 weeks

Population: Intent to treat, excluding outliers

Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Each of the PEP questions is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)

Outcome measures

Measure	Drug: IX-01 n=52 Participants Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity IX-01	Placebo n=25 Participants Two to four capsules administered orally, 1-6 hours prior to sexual activity Placebo
Proportion of Participants With ≥ 2 Category Increase in Control and ≥ 1 Category Decrease in Personal Distress on a Patient Reported Outcome (PRO) Measure	0.17 proportion of participants	0 proportion of participants

SECONDARY outcome

Timeframe: Baseline to last 4 weeks on treatment

Population: Intent to treat, excluding outliers

'Baseline' time period defined as Day -28 - Day 0. 'Last 4 Weeks' time period defined as the 28 days prior to last time subject took study drug and after Day 14.

Analysis excludes two subjects from ITT population: #010-012 (placebo) and #888-018 (active). Adjusted for treatment, baseline IELT, baseline percentage, country and site.

Outcome measures

Measure	Drug: IX-01 n=54 Participants Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity IX-01	Placebo n=25 Participants Two to four capsules administered orally, 1-6 hours prior to sexual activity Placebo
Change in Percentage of Intercourse Attempts Lasting Longer Than 1 Minute From Baseline to Last 4 Weeks on Treatment	37.6 percentage of attempts Interval 17.8 to 57.3	13.5 percentage of attempts Interval -9.1 to 36.2

SECONDARY outcome

Timeframe: Start of Treatment to end of study (approximately 10 weeks)

Population: Intent to treat, excluding outliers

Number of participants with at least one treatment-emergent adverse event

Outcome measures

Measure	Drug: IX-01 n=56 Participants Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity IX-01	Placebo n=30 Participants Two to four capsules administered orally, 1-6 hours prior to sexual activity Placebo
Incidence of Treatment-emergent Adverse Events	12 participants	9 participants

Adverse Events

Drug: IX-01

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Drug: IX-01 n=56 participants at risk Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity IX-01	Placebo n=30 participants at risk Two to four capsules administered orally, 1-6 hours prior to sexual activity Placebo
Gastrointestinal disorders Nausea	3.6% 2/56 Two patients did not take any study medication hence 56 reported and not 58	3.3% 1/30 Two patients did not take any study medication hence 56 reported and not 58
Gastrointestinal disorders Dry Mouth	1.8% 1/56 Two patients did not take any study medication hence 56 reported and not 58	3.3% 1/30 Two patients did not take any study medication hence 56 reported and not 58
Gastrointestinal disorders Dental caries	1.8% 1/56 Two patients did not take any study medication hence 56 reported and not 58	0.00% 0/30 Two patients did not take any study medication hence 56 reported and not 58
Gastrointestinal disorders Diarrhea	1.8% 1/56 Two patients did not take any study medication hence 56 reported and not 58	0.00% 0/30 Two patients did not take any study medication hence 56 reported and not 58
Gastrointestinal disorders Dyspepsia	0.00% 0/56 Two patients did not take any study medication hence 56 reported and not 58	3.3% 1/30 Two patients did not take any study medication hence 56 reported and not 58
Gastrointestinal disorders Hemorrhoids	0.00% 0/56 Two patients did not take any study medication hence 56 reported and not 58	3.3% 1/30 Two patients did not take any study medication hence 56 reported and not 58
Gastrointestinal disorders Peridontal inflammation	1.8% 1/56 Two patients did not take any study medication hence 56 reported and not 58	0.00% 0/30 Two patients did not take any study medication hence 56 reported and not 58
General disorders Feeling jittery	0.00% 0/56 Two patients did not take any study medication hence 56 reported and not 58	3.3% 1/30 Two patients did not take any study medication hence 56 reported and not 58
Infections and infestations Upper respiratory tract infection	1.8% 1/56 Two patients did not take any study medication hence 56 reported and not 58	6.7% 2/30 Two patients did not take any study medication hence 56 reported and not 58
Infections and infestations Lower respiratory tract infection	0.00% 0/56 Two patients did not take any study medication hence 56 reported and not 58	3.3% 1/30 Two patients did not take any study medication hence 56 reported and not 58
Ear and labyrinth disorders Ear Pain	0.00% 0/56 Two patients did not take any study medication hence 56 reported and not 58	3.3% 1/30 Two patients did not take any study medication hence 56 reported and not 58
Infections and infestations Skin infection	1.8% 1/56 Two patients did not take any study medication hence 56 reported and not 58	0.00% 0/30 Two patients did not take any study medication hence 56 reported and not 58
Infections and infestations Tooth abscess	0.00% 0/56 Two patients did not take any study medication hence 56 reported and not 58	3.3% 1/30 Two patients did not take any study medication hence 56 reported and not 58
Injury, poisoning and procedural complications Lacerations	0.00% 0/56 Two patients did not take any study medication hence 56 reported and not 58	3.3% 1/30 Two patients did not take any study medication hence 56 reported and not 58
Investigations Gamma-glutamyltransferase increased	1.8% 1/56 Two patients did not take any study medication hence 56 reported and not 58	3.3% 1/30 Two patients did not take any study medication hence 56 reported and not 58
Investigations Hepatic enzyme increased	1.8% 1/56 Two patients did not take any study medication hence 56 reported and not 58	0.00% 0/30 Two patients did not take any study medication hence 56 reported and not 58
Investigations Laboratory test abnormal	1.8% 1/56 Two patients did not take any study medication hence 56 reported and not 58	0.00% 0/30 Two patients did not take any study medication hence 56 reported and not 58
Investigations Metabolic function test abnormal	1.8% 1/56 Two patients did not take any study medication hence 56 reported and not 58	0.00% 0/30 Two patients did not take any study medication hence 56 reported and not 58
Nervous system disorders Headache	1.8% 1/56 Two patients did not take any study medication hence 56 reported and not 58	0.00% 0/30 Two patients did not take any study medication hence 56 reported and not 58
Nervous system disorders Paraesthesia	1.8% 1/56 Two patients did not take any study medication hence 56 reported and not 58	0.00% 0/30 Two patients did not take any study medication hence 56 reported and not 58
Psychiatric disorders Libido decreased	1.8% 1/56 Two patients did not take any study medication hence 56 reported and not 58	0.00% 0/30 Two patients did not take any study medication hence 56 reported and not 58
Renal and urinary disorders Renal Colic	0.00% 0/56 Two patients did not take any study medication hence 56 reported and not 58	3.3% 1/30 Two patients did not take any study medication hence 56 reported and not 58
Respiratory, thoracic and mediastinal disorders Rhinitis, allergic	0.00% 0/56 Two patients did not take any study medication hence 56 reported and not 58	3.3% 1/30 Two patients did not take any study medication hence 56 reported and not 58
Skin and subcutaneous tissue disorders Dermatitis	1.8% 1/56 Two patients did not take any study medication hence 56 reported and not 58	0.00% 0/30 Two patients did not take any study medication hence 56 reported and not 58

Additional Information

Chief Medical Officer

Ixchelsis Limited

Phone: 44(0)1227-832760

Email: ian.osterloh@ixchelsis.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor may choose to collaborate on authorship, and sponsor's agent has 60-day review
• Publication restrictions are in place

Restriction type: OTHER