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

Phase 2

Completed

• Conditions: Premature Ejaculation
• Interventions: Drug: Placebo; Drug: IX-01 1200 mg; Drug: IX-01 400 mg; Drug: IX-01 800 mg

• Registration Number: NCT03055806
• Lead Sponsor: Ixchelsis Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-14
• Study First Posted: 2017-02-16
• Study Start: 2017-02-28
• Primary Completion: 2017-11-17
• Study Completion: 2017-12-06
• Status Verified: 2019-03
• Disposition First Submitted: 2019-03-10
• Disposition First Submitted QC: 2019-04-24
• Disposition First Posted: 2019-04-30
• Results First Submitted: 2019-09-13
• Results First Submitted QC: 2019-09-13
• Last Update Submitted: 2019-09-13
• Results First Posted: 2019-10-07
• Last Update Posted: 2019-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 239

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
IX-01 800 mg	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
IX-01 800 mg	Placebo	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
IX-01 1200 mg	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
IX-01 400 mg	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
IX-01 400 mg	Placebo	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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'.
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.
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.
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.
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.
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'.
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).
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).

Trial Locations

Locations (29)

Boston Clinical Trials Inc; 🇺🇸 Boston, Massachusetts, United States

Radiant Research, Inc. - Anderson; 🇺🇸 Anderson, South Carolina, United States

Coastal Clinical Research Inc; 🇺🇸 Mobile, Alabama, United States

Clinical Research Center of Florida; 🇺🇸 Pompano Beach, Florida, United States

A G A Clinical Trials; 🇺🇸 Hialeah, Florida, United States

South Florida Medical Research Inc.; 🇺🇸 Aventura, Florida, United States

Columbine Family Practice - Radiant; 🇺🇸 Littleton, Colorado, United States

Mens Health Boston; 🇺🇸 Chestnut Hill, Massachusetts, United States

Center for Marital and Sexual Health of South Florida; 🇺🇸 West Palm Beach, Florida, United States

Northwest Behavioral Research Center; 🇺🇸 Roswell, Georgia, United States

Accumed Research Associates; 🇺🇸 Garden City, New York, United States

Radiant Research, Inc. - Akron; 🇺🇸 Akron, Ohio, United States

Drug Trials America; 🇺🇸 Hartsdale, New York, United States

Manhattan Medical Research; 🇺🇸 New York, New York, United States

Radiant Research, Inc. - Columbus; 🇺🇸 Columbus, Ohio, United States

Urologic Consultants of Southeastern Pennsylvania; 🇺🇸 Bala-Cynwyd, Pennsylvania, United States

Miriam Hospital / The Men's Health Center; 🇺🇸 Providence, Rhode Island, United States

Radiant Research, Inc. - Dallas; 🇺🇸 Dallas, Texas, United States

Radiant Research, Inc. - Salt Lake City; 🇺🇸 Murray, Utah, United States

San Diego Sexual Medicine; 🇺🇸 San Diego, California, United States

Clifford J Molin MD LTD - Radiant; 🇺🇸 Las Vegas, Nevada, United States

Radiant Research, Inc. - Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Clinical Trials of Texas Incorporated; 🇺🇸 San Antonio, Texas, United States

Radiant Research Inc - San Antonio; 🇺🇸 San Antonio, Texas, United States

Family Practice Specialists - Radiant; 🇺🇸 Phoenix, Arizona, United States

Radiant Research, Inc. - Phoenix SE; 🇺🇸 Chandler, Arizona, United States

Radiant Research, Inc. - Greer; 🇺🇸 Greer, South Carolina, United States

Desert Clinical Research, LLC - Radiant; 🇺🇸 Mesa, Arizona, United States

Center For Pharmaceutical Research; 🇺🇸 Kansas City, Missouri, United States