Clinical trial NCT03055806: IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Premature Ejaculation
Keywords: Sex
Sexual Dysfunction
IX-01
Lead sponsor: Ixchelsis Limited
Sponsor class: INDUSTRY
First posted: 2017-02-16
Enrollment: 239
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period
timeFrame: Last 4 weeks of treatment compared to baseline
Secondary outcomes:
measure: Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline
timeFrame: Last 4 weeks of treatment compared to baseline
measure: 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
timeFrame: Last 4 weeks of treatment compared to baseline
measure: Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire
timeFrame: Baseline to the end of treatment (approximately 8 weeks)
measure: 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.
timeFrame: Baseline to the end of treatment (approximately 8 weeks)
measure: Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 in Ejaculation-related Personal Distress on the Premature Ejaculation Profile (PEP) Questionnaire
timeFrame: Baseline to the end of treatment (approximately 8 weeks)
measure: 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
timeFrame: Baseline to the end of treatment (approximately 8 weeks)
measure: Mean Change From Baseline in Score on Control of Ejaculation
timeFrame: Last 4 weeks of treatment compared to baseline
measure: Mean Change From Baseline in Score on Ejaculation-related Personal Distress
timeFrame: Last 4 weeks of treatment compared to baseline
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research Inc
state: Alabama
city: Chandler
country: United States
facility: Radiant Research, Inc. - Phoenix SE
state: Arizona
city: Mesa
country: United States
facility: Desert Clinical Research, LLC - Radiant
state: Arizona
city: Phoenix
country: United States
facility: Family Practice Specialists - Radiant
state: Arizona
city: San Diego
country: United States
facility: San Diego Sexual Medicine
state: California
city: Littleton
country: United States
facility: Columbine Family Practice - Radiant
state: Colorado
city: Aventura
country: United States
facility: South Florida Medical Research Inc.
state: Florida
city: Hialeah
country: United States
facility: A G A Clinical Trials
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: West Palm Beach
country: United States
facility: Center for Marital and Sexual Health of South Florida
state: Florida
city: Roswell
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Boston
country: United States
facility: Boston Clinical Trials Inc
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Mens Health Boston
state: Massachusetts
city: Kansas City
country: United States
facility: Center For Pharmaceutical Research
state: Missouri
city: Las Vegas
country: United States
facility: Clifford J Molin MD LTD - Radiant
state: Nevada
city: Garden City
country: United States
facility: Accumed Research Associates
state: New York
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: New York
country: United States
facility: Manhattan Medical Research
state: New York
city: Akron
country: United States
facility: Radiant Research, Inc. - Akron
state: Ohio
city: Cincinnati
country: United States
facility: Radiant Research, Inc. - Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Radiant Research, Inc. - Columbus
state: Ohio
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of Southeastern Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Miriam Hospital / The Men's Health Center
state: Rhode Island
city: Anderson
country: United States
facility: Radiant Research, Inc. - Anderson
state: South Carolina
city: Greer
country: United States
facility: Radiant Research, Inc. - Greer
state: South Carolina
city: Dallas
country: United States
facility: Radiant Research, Inc. - Dallas
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas Incorporated
state: Texas
city: San Antonio
country: United States
facility: Radiant Research Inc - San Antonio
state: Texas
city: Murray
country: United States
facility: Radiant Research, Inc. - Salt Lake City
state: Utah
Study officials:
References:
citation: Althof S, Osterloh IH, Muirhead GJ, George K, Girard N; PEDRIX Multi-Centre Study Group. The Oxytocin Antagonist Cligosiban Fails to Prolong Intravaginal Ejaculatory Latency in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Phase IIb trial (PEDRIX). J Sex Med. 2019 Aug;16(8):1188-1198. doi: 10.1016/j.jsxm.2019.05.015.