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

Premature Ejaculation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055806
• Other study ID #: IX-0105
• Status: Completed
• Phase: Phase 2
• Start date: February 28, 2017
• Est. completion date: December 6, 2017

Study information

• Verified date: March 2019
• Source: Ixchelsis Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: December 6, 2017
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

Drug:
• IX-01 400 mg
IX-01 400 mg caplet
• Placebo
Placebo caplet(s)
• IX-01 800 mg
IX-01 800 mg (Two 400 mg caplets)
• IX-01 1200 mg
IX-01 1200 mg (Three 400 mg caplets)

Locations

Country	Name	City	State
United States	Radiant Research, Inc. - Akron	Akron	Ohio
United States	Radiant Research, Inc. - Anderson	Anderson	South Carolina
United States	South Florida Medical Research Inc.	Aventura	Florida
United States	Urologic Consultants of Southeastern Pennsylvania	Bala-Cynwyd	Pennsylvania
United States	Boston Clinical Trials Inc	Boston	Massachusetts
United States	Radiant Research, Inc. - Phoenix SE	Chandler	Arizona
United States	Mens Health Boston	Chestnut Hill	Massachusetts
United States	Radiant Research, Inc. - Cincinnati	Cincinnati	Ohio
United States	Radiant Research, Inc. - Columbus	Columbus	Ohio
United States	Radiant Research, Inc. - Dallas	Dallas	Texas
United States	Accumed Research Associates	Garden City	New York
United States	Radiant Research, Inc. - Greer	Greer	South Carolina
United States	Drug Trials America	Hartsdale	New York
United States	A G A Clinical Trials	Hialeah	Florida
United States	Center For Pharmaceutical Research	Kansas City	Missouri
United States	Clifford J Molin MD LTD - Radiant	Las Vegas	Nevada
United States	Columbine Family Practice - Radiant	Littleton	Colorado
United States	Desert Clinical Research, LLC - Radiant	Mesa	Arizona
United States	Coastal Clinical Research Inc	Mobile	Alabama
United States	Radiant Research, Inc. - Salt Lake City	Murray	Utah
United States	Manhattan Medical Research	New York	New York
United States	Family Practice Specialists - Radiant	Phoenix	Arizona
United States	Clinical Research Center of Florida	Pompano Beach	Florida
United States	Miriam Hospital / The Men's Health Center	Providence	Rhode Island
United States	Northwest Behavioral Research Center	Roswell	Georgia
United States	Clinical Trials of Texas Incorporated	San Antonio	Texas
United States	Radiant Research Inc - San Antonio	San Antonio	Texas
United States	San Diego Sexual Medicine	San Diego	California
United States	Center for Marital and Sexual Health of South Florida	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ixchelsis Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period	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.	Last 4 weeks of treatment compared to baseline
Secondary	Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With 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.	Last 4 weeks of treatment compared to baseline
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	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.	Last 4 weeks of treatment compared to baseline
Secondary	Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire	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.	Baseline to the end of treatment (approximately 8 weeks)
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.	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'.	Baseline to the end of treatment (approximately 8 weeks)
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	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'.	Baseline to the end of treatment (approximately 8 weeks)
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	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).	Baseline to the end of treatment (approximately 8 weeks)
Secondary	Mean Change From Baseline in Score on Control of Ejaculation	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).	Last 4 weeks of treatment compared to baseline
Secondary	Mean Change From Baseline in Score on Ejaculation-related Personal Distress	Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.	Last 4 weeks of treatment compared to baseline