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

Completed · Phase 2 · Has a placebo group

Conditions studied: Premature Ejaculation

In brief

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.

Key facts

Study ID

NCT03055806

Run by

Ixchelsis Limited

People needed

239

Starts

2017-02-28

Expected to finish

2017-12-06

Last updated by the study team

2019-10-07

Who can join

Age: 18 and older, up to 60. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Men aged ≥18 years and ≤60 years in stable (≥6 months) heterosexual relationship and who have lifelong PE.
• Premature ejaculation ≤1 minute on ≥75% attempts at sexual intercourse during the run-in period.
• Meets other aspects of ISSM definition.
• 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.
• Partner not planning pregnancy and willing to use contraception (unless not of childbearing potential, e.g, surgically sterilized).
• Willing to limit use of alcohol on days in which he takes study drug.
• Capable of giving written informed consent.

You may not qualify if…

• IELT value >2 minutes during the run-in period.
• <4 attempts at sexual intercourse during the run-in period.
• Any patient who rates his control of ejaculation as fair, good, or very good.
• Any patient who rates his ejaculation-related "personal distress" as "not at all" or "a little bit".
• Erectile Dysfunction.
• 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.
• History (last 6 months) of use of Botox or similar product to treat PE.
• Has received IX-01 in a previous clinical study.
• Unwilling to stop other treatments for PE (including but not limited to pharmacological, sex therapy, psychotherapy multiple condoms, and prior masturbation).
• Any other sexual disorder of patient or partner that could interfere with results.
• Any current sexually transmitted disease.
• Any major medical condition of patient that could interfere with ability to have sexual activity and/or require hospital treatment.
• Body mass index (BMI) >40 kg/m2 or weight <60 kg.
• Participation in a clinical drug study anytime during the 30 days prior to screening.
• Human immunodeficiency virus (HIV), hepatitis B.
• History of prostate disease or clinically significant prostate disease.
• History of myocardial infarction, coronary bypass surgery, coronary artery angioplasty, unstable angina, clinically evident congestive heart failure, cardiac pacemaker, or cerebrovascular accident.
• Known or suspected history of significant cardiac arrhythmias.
• History of drug-induced allergic reactions including skin reactions.
• Significant psychiatric disease and/or risk of suicidal tendency.
• History of or other evidence of recent alcohol or drug abuse.

Where it is running

• Coastal Clinical Research Inc — Mobile, Alabama, United States
• Radiant Research, Inc. - Phoenix SE — Chandler, Arizona, United States
• Desert Clinical Research, LLC - Radiant — Mesa, Arizona, United States
• Family Practice Specialists - Radiant — Phoenix, Arizona, United States
• San Diego Sexual Medicine — San Diego, California, United States
• Columbine Family Practice - Radiant — Littleton, Colorado, United States
• South Florida Medical Research Inc. — Aventura, Florida, United States
• A G A Clinical Trials — Hialeah, Florida, United States
• Clinical Research Center of Florida — Pompano Beach, Florida, 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
• Boston Clinical Trials Inc — Boston, Massachusetts, United States
• Mens Health Boston — Chestnut Hill, Massachusetts, United States
• Center For Pharmaceutical Research — Kansas City, Missouri, United States
• Clifford J Molin MD LTD - Radiant — Las Vegas, Nevada, United States
• Accumed Research Associates — Garden City, New York, United States
• Drug Trials America — Hartsdale, New York, United States
• Manhattan Medical Research — New York, New York, United States
• Radiant Research, Inc. - Akron — Akron, Ohio, United States
• Radiant Research, Inc. - Cincinnati — Cincinnati, Ohio, 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. - Anderson — Anderson, South Carolina, United States
• Radiant Research, Inc. - Greer — Greer, South Carolina, United States

Full record on ClinicalTrials.gov

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