IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)
NCT ID: NCT03055806
Last Updated: 2019-10-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
239 participants
INTERVENTIONAL
2017-02-28
2017-12-06
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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 1200 mg
IX-01 1200 mg (Three 400 mg caplets)
Placebo
Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Placebo
Placebo caplet(s)
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
Placebo
Placebo caplet(s)
IX-01 800 mg
IX-01 800 mg (Two 400 mg caplets)
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
IX-01 400 mg caplet
Placebo
Placebo caplet(s)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
60 Years
MALE
No
Sponsors
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Ixchelsis Limited
INDUSTRY
Responsible Party
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Locations
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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
Radiant Research, Inc. - Dallas
Dallas, Texas, United States
Clinical Trials of Texas Incorporated
San Antonio, Texas, United States
Radiant Research Inc - San Antonio
San Antonio, Texas, United States
Radiant Research, Inc. - Salt Lake City
Murray, Utah, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IX-0105
Identifier Type: -
Identifier Source: org_study_id
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