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

• Sponsor: Ixchelsis Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03055806
• Collaborator: (none)
• Enrollment: 239
• Locations: 29
• Arms: 4
• Actual Duration (Months): 9.2
• Patients Per Site: 8.2
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Ejaculation	Drug: IX-01 400 mg; Drug: Placebo; Drug: IX-01 800 mg; Drug: IX-01 1200 mg	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 239 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2b, 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effects of 3 Different Dose Levels of IX-01 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (PE)
• Actual Study Start Date: Feb 28, 2017
• Actual Primary Completion Date: Nov 17, 2017
• Actual Study Completion Date: Dec 6, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: IX-01 1200 mg; IX-01 1200 mg (Three 400 mg caplets)
Placebo Comparator: Placebo Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	Drug: Placebo; Placebo caplet(s)
Experimental: 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	Drug: Placebo; Placebo caplet(s); Drug: IX-01 800 mg; IX-01 800 mg (Two 400 mg caplets)
Experimental: 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	Drug: IX-01 400 mg; IX-01 400 mg caplet; Drug: Placebo; Placebo caplet(s)

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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'.

5. 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'.

6. 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).

7. 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).

8. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coastal Clinical Research Inc	Mobile	Alabama	United States	36608
2	Radiant Research, Inc. - Phoenix SE	Chandler	Arizona	United States	85224
3	Desert Clinical Research, LLC - Radiant	Mesa	Arizona	United States	85213
4	Family Practice Specialists - Radiant	Phoenix	Arizona	United States	85018
5	San Diego Sexual Medicine	San Diego	California	United States	92120
6	Columbine Family Practice - Radiant	Littleton	Colorado	United States	80128
7	South Florida Medical Research Inc.	Aventura	Florida	United States	33180
8	A G A Clinical Trials	Hialeah	Florida	United States	33012
9	Clinical Research Center of Florida	Pompano Beach	Florida	United States	33060
10	Center for Marital and Sexual Health of South Florida	West Palm Beach	Florida	United States	33401
11	Northwest Behavioral Research Center	Roswell	Georgia	United States	30076
12	Boston Clinical Trials Inc	Boston	Massachusetts	United States	02131
13	Mens Health Boston	Chestnut Hill	Massachusetts	United States	02467
14	Center For Pharmaceutical Research	Kansas City	Missouri	United States	64114
15	Clifford J Molin MD LTD - Radiant	Las Vegas	Nevada	United States	89128
16	Accumed Research Associates	Garden City	New York	United States	11530-1664
17	Drug Trials America	Hartsdale	New York	United States	10530
18	Manhattan Medical Research	New York	New York	United States	10016
19	Radiant Research, Inc. - Akron	Akron	Ohio	United States	44311
20	Radiant Research, Inc. - Cincinnati	Cincinnati	Ohio	United States	45236
21	Radiant Research, Inc. - Columbus	Columbus	Ohio	United States	43212
22	Urologic Consultants of Southeastern Pennsylvania	Bala-Cynwyd	Pennsylvania	United States	19004
23	Miriam Hospital / The Men's Health Center	Providence	Rhode Island	United States	02906
24	Radiant Research, Inc. - Anderson	Anderson	South Carolina	United States	29621
25	Radiant Research, Inc. - Greer	Greer	South Carolina	United States	29650
26	Radiant Research, Inc. - Dallas	Dallas	Texas	United States	75231
27	Clinical Trials of Texas Incorporated	San Antonio	Texas	United States	78229
28	Radiant Research Inc - San Antonio	San Antonio	Texas	United States	78229
29	Radiant Research, Inc. - Salt Lake City	Murray	Utah	United States	84123

Sponsors and Collaborators

• Ixchelsis Limited

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 16, 2017

More Information

Publications

None provided.

• Responsible Party: Ixchelsis Limited
• ClinicalTrials.gov Identifier: NCT03055806
• Other Study ID Numbers: IX-0105
• First Posted: Feb 16, 2017
• Last Update Posted: Oct 7, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ixchelsis Limited: Sex; Sexual Dysfunction; IX-01
• Additional relevant MeSH terms: Premature Birth; Premature Ejaculation

Study Results

Participant Flow

Arm/Group Title	Placebo	IX-01 400 mg	IX-01 800 mg	IX-01 1200 mg
Arm/Group Description	Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	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	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	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
Period Title: Overall Study
STARTED	48	48	71	72
COMPLETED	42	41	58	57
NOT COMPLETED	6	7	13	15

Baseline Characteristics

Arm/Group Title	Placebo	IX-01 400 mg	IX-01 800 mg	IX-01 1200 mg	Total
Arm/Group Description	Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	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	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	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	Total of all reporting groups
Overall Participants	46	48	68	69	231
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.2 (9.13)	41.8 (9.28)	40.1 (9.78)	43.8 (8.63)	41.6 (9.29)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%
Male	46 100%	48 100%	68 100%	69 100%	231 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 15.2%	5 10.4%	11 16.2%	19 27.5%	42 18.2%
Not Hispanic or Latino	39 84.8%	43 89.6%	57 83.8%	50 72.5%	189 81.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	40 87%	35 72.9%	58 85.3%	57 82.6%	190 82.3%
Black or African American	4 8.7%	8 16.7%	7 10.3%	8 11.6%	27 11.7%
Asian	1 2.2%	2 4.2%	2 2.9%	2 2.9%	7 3%
American Indian or Alaska Native	0 0%	0 0%	1 1.5%	0 0%	1 0.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Other	1 2.2%	3 6.3%	0 0%	2 2.9%	6 2.6%
Region of Enrollment (participants) [Number]
United States	46 100%	48 100%	68 100%	69 100%	231 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Placebo	IX-01 400 mg	IX-01 800 mg	IX-01 1200 mg
Arm/Group Description	Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	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	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	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
Measure Participants	46	46	65	64
Least Squares Mean (Standard Error) [Seconds]	42.6 (10.9)	39.7 (10.6)	44.5 (9.0)	29.2 (9.1)

2. Secondary Outcome

Title	Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Placebo	IX-01 400 mg	IX-01 800 mg	IX-01 1200 mg
Arm/Group Description	Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	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	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	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
Measure Participants	46	46	65	64
Least Squares Mean (Standard Error) [Fold change]	1.77 (0.11)	1.56 (0.11)	1.79 (0.09)	1.54 (0.09)

3. Secondary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Placebo	IX-01 400 mg	IX-01 800 mg	IX-01 1200 mg
Arm/Group Description	Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	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	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	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
Measure Participants	46	46	65	64
Number [Proportion of participants]	0.30 0.7%	0.20 0.4%	0.26 0.4%	0.20 0.3%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Placebo	IX-01 400 mg	IX-01 800 mg	IX-01 1200 mg
Arm/Group Description	Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	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	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	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
Measure Participants	46	46	65	64
Better	0.12 0.3%	0.05 0.1%	0.07 0.1%	0.07 0.1%
Much better	0 0%	0.02 0%	0.12 0.2%	0 0%

5. Secondary Outcome

Title	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.
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Placebo	IX-01 400 mg	IX-01 800 mg	IX-01 1200 mg
Arm/Group Description	Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	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	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	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
Measure Participants	43	44	61	62
Number [Proportion of participants]	0.35 0.8%	0.18 0.4%	0.33 0.5%	0.18 0.3%

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Placebo	IX-01 400 mg	IX-01 800 mg	IX-01 1200 mg
Arm/Group Description	Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	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	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	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
Measure Participants	43	44	61	62
Number [Proportion of participants]	0.37 0.8%	0.25 0.5%	0.39 0.6%	0.23 0.3%

7. Secondary Outcome

Title	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
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Placebo	IX-01 400 mg	IX-01 800 mg	IX-01 1200 mg
Arm/Group Description	Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	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	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	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
Measure Participants	46	46	65	64
Number [Proportion of participants]	0.13 0.3%	0.11 0.2%	0.25 0.4%	0.08 0.1%

8. Secondary Outcome

Title	Mean Change From Baseline in Score on Control of Ejaculation
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Placebo	IX-01 400 mg	IX-01 800 mg	IX-01 1200 mg
Arm/Group Description	Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	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	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	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
Measure Participants	46	46	65	64
Mean (Standard Deviation) [score on a scale]	0.55 (0.938)	0.46 (0.837)	0.58 (0.868)	0.32 (0.619)

9. Secondary Outcome

Title	Mean Change From Baseline in Score on Ejaculation-related Personal Distress
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Placebo	IX-01 400 mg	IX-01 800 mg	IX-01 1200 mg
Arm/Group Description	Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	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	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	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
Measure Participants	46	46	65	64
Mean (Standard Deviation) [score on a scale]	0.73 (1.139)	0.38 (1.036)	0.58 (0.933)	0.51 (0.898)

Adverse Events

Time Frame	Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Arm/Group Title	Placebo		IX-01 400 mg		IX-01 800 mg		IX-01 1200 mg
Arm/Group Description	Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity		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		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		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
All Cause Mortality
	Placebo		IX-01 400 mg		IX-01 800 mg		IX-01 1200 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/48 (0%)		0/68 (0%)		0/69 (0%)
Serious Adverse Events
	Placebo		IX-01 400 mg		IX-01 800 mg		IX-01 1200 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/48 (0%)		0/68 (0%)		0/69 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		IX-01 400 mg		IX-01 800 mg		IX-01 1200 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/46 (26.1%)		8/48 (16.7%)		12/68 (17.6%)		18/69 (26.1%)
Cardiac disorders
Angina pectoris	0/46 (0%)		0/48 (0%)		1/68 (1.5%)		0/69 (0%)
Gastrointestinal disorders
Abdominal pain	0/46 (0%)		0/48 (0%)		1/68 (1.5%)		0/69 (0%)
Abdominal pain upper	0/46 (0%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
Dry mouth	0/46 (0%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
Dyspepsia	0/46 (0%)		1/48 (2.1%)		0/68 (0%)		0/69 (0%)
Faeces discoloured	0/46 (0%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
General disorders
Asthenia	0/46 (0%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
Energy increased	0/46 (0%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
Fatigue	0/46 (0%)		1/48 (2.1%)		0/68 (0%)		0/69 (0%)
Pyrexia	0/46 (0%)		1/48 (2.1%)		0/68 (0%)		0/69 (0%)
Hepatobiliary disorders
Cholelithiasis	0/46 (0%)		0/48 (0%)		1/68 (1.5%)		0/69 (0%)
Infections and infestations
Bronchitis	0/46 (0%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
Gastroenteritis	0/46 (0%)		0/48 (0%)		1/68 (1.5%)		0/69 (0%)
Nasopharyngitis	1/46 (2.2%)		1/48 (2.1%)		1/68 (1.5%)		2/69 (2.9%)
Otitis media	0/46 (0%)		1/48 (2.1%)		0/68 (0%)		0/69 (0%)
Tinea cruris	0/46 (0%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
Upper respiratory tract infection	2/46 (4.3%)		0/48 (0%)		1/68 (1.5%)		0/69 (0%)
Injury, poisoning and procedural complications
Concussion	1/46 (2.2%)		0/48 (0%)		0/68 (0%)		0/69 (0%)
Laceration	0/46 (0%)		0/48 (0%)		1/68 (1.5%)		1/69 (1.4%)
Ligament sprain	0/46 (0%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
Skin abrasion	1/46 (2.2%)		0/48 (0%)		0/68 (0%)		0/69 (0%)
Stress fracture	0/46 (0%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
Investigations
Blood potassium increased	0/46 (0%)		0/48 (0%)		1/68 (1.5%)		0/69 (0%)
Blood pressure increased	1/46 (2.2%)		0/48 (0%)		0/68 (0%)		0/69 (0%)
Haematocrit increased	0/46 (0%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
Neutrophil count increased	0/46 (0%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
Red blood cell count increased	0/46 (0%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
Red blood cells urine positive	0/46 (0%)		1/48 (2.1%)		0/68 (0%)		0/69 (0%)
Weight decreased	0/46 (0%)		0/48 (0%)		1/68 (1.5%)		0/69 (0%)
White blood cell count increased	0/46 (0%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
Metabolism and nutrition disorders
Diabetes mellitus	1/46 (2.2%)		0/48 (0%)		0/68 (0%)		0/69 (0%)
Hyperkalaemia	0/46 (0%)		0/48 (0%)		1/68 (1.5%)		0/69 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/46 (0%)		0/48 (0%)		1/68 (1.5%)		0/69 (0%)
Back pain	1/46 (2.2%)		0/48 (0%)		1/68 (1.5%)		0/69 (0%)
Joint hyperextension	0/46 (0%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
Myalgia	1/46 (2.2%)		0/48 (0%)		0/68 (0%)		0/69 (0%)
Nervous system disorders
Dizziness	0/46 (0%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
Headache	3/46 (6.5%)		2/48 (4.2%)		2/68 (2.9%)		2/69 (2.9%)
Hypersomnia	0/46 (0%)		0/48 (0%)		1/68 (1.5%)		0/69 (0%)
Memory impairment	0/46 (0%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
Parosmia	1/46 (2.2%)		0/48 (0%)		0/68 (0%)		0/69 (0%)
Poor quality sleep	0/46 (0%)		1/48 (2.1%)		0/68 (0%)		0/69 (0%)
Psychiatric disorders
Abnormal dreams	1/46 (2.2%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
Depressed mood	1/46 (2.2%)		0/48 (0%)		0/68 (0%)		0/69 (0%)
Insomnia	0/46 (0%)		1/48 (2.1%)		1/68 (1.5%)		0/69 (0%)
Libido decreased	0/46 (0%)		1/48 (2.1%)		1/68 (1.5%)		0/69 (0%)
Libido increased	0/46 (0%)		1/48 (2.1%)		0/68 (0%)		0/69 (0%)
Reproductive system and breast disorders
Erectile dysfunction	1/46 (2.2%)		0/48 (0%)		1/68 (1.5%)		1/69 (1.4%)
Respiratory, thoracic and mediastinal disorders
Nasal congestion	0/46 (0%)		0/48 (0%)		1/68 (1.5%)		0/69 (0%)
Oropharyngeal pain	0/46 (0%)		0/48 (0%)		0/68 (0%)		2/69 (2.9%)
Rhinitis allergic	0/46 (0%)		0/48 (0%)		0/68 (0%)		1/69 (1.4%)
Skin and subcutaneous tissue disorders
Rash maculo-papular	0/46 (0%)		0/48 (0%)		1/68 (1.5%)		0/69 (0%)
Vascular disorders
Hypertension	0/46 (0%)		0/48 (0%)		1/68 (1.5%)		1/69 (1.4%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor may chose to collaborate on authorship, and sponsor's agent has 60-day review.