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

NCT02232425 | Completed Phase 2 Results

• 1 other identifier: IX-0103
• Study Type: interventional
• Target: 88
• Locations: 2 countries
• Sites: 10

Brief Summary

The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong premature ejaculation.

Conditions

Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

• Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)

  IX-01 versus placebo. Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred

  Last 4 weeks of treatment compared to baseline

Secondary Outcomes (12)

• Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale

  Baseline to the end of treatment (approximately 8 weeks)

• Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT)

  Last 4 weeks of treatment compared to baseline

• Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time)

  Last 4 weeks of treatment compared to baseline

• Mean Change in Score on Control of Timing of Ejaculation

  Last 4 weeks of treatment compared to baseline

• Mean Change in Score on Ejaculation-related Personal Distress

  Last 4 weeks of treatment compared to baseline

Study Arms (2)

Drug: IX-01

EXPERIMENTAL

Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity

Drug: IX-01

Placebo

PLACEBO COMPARATOR

Two to four capsules administered orally, 1-6 hours prior to sexual activity

Drug: Placebo

Interventions

IX-01 DRUG

Drug: IX-01

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• In stable (≥ 6 months) heterosexual relationship
• Have life-long (primary) premature ejaculation
• Have premature ejaculation confirmed by Intravaginal Ejaculatory Latency Time (IELT) less than or equal to (≤) 1 minute on ≥ 75% attempts at sexual intercourse
• Meet other aspects of the International Society for Sexual Medicine (ISSM) definition for lifelong premature ejaculation (PE), including inability to delay ejaculation on all or nearly all vaginal penetrations and negative personal consequences such as distress, bother and frustration
• Willing to attempt intercourse at least 4 times during run-in period and at least 8 more times during double-blind part of the study
• Not planning pregnancy with his partner and he is willing to use contraception (unless not of child-bearing potential, e.g., surgically sterilised)
• Willing to limit use of alcohol on days in which they take study drug (not more than three drinks, where one drink is defined as a 12 ounce (oz), 360 milliliter (mL) bottle of beer, a 5 oz (150 mL) glass of wine, or a 1½ oz (45 mL distilled spirits)
• Capable of giving written informed consent

You may not qualify if:

• An Intravaginal Ejaculatory Latency Time (IELT) value ≥ 2 minutes during run-in period
• Less than (\<) 4 attempts at sexual intercourse during run-in (screening may be extended or patient may be rescreened if there are extenuating circumstances)
• A rating of control of ejaculation as fair, good, or very good on the Premature Ejaculation Profile (PEP) questionnaire prior to study
• Co-existing Erectile Dysfunction - International Index of Erectile Dysfunction (IIEF) erectile function domain \< 22 during run-in
• Concomitant use of Phosphodiesterase 5 (PDE5) inhibitors, intracavernosal injections, penile implants, Selective Serotonin Reuptake Inhibitors (SSRI's) or Serotonin-Norepinephrine Reuptake Inhibitors (SSNRI's), tricyclic antidepressants (for example (e.g.) clomipramine), monoamine oxidase inhibitors, alpha blockers, 5 alpha reductase inhibitors (including propecia for hair loss), topical anaesthetics, and/or tramadol
• History (last 6 months) of use of Botox or similar product to treat premature ejaculation
• Unwilling to stop other treatments for premature ejaculation (including but not limited to pharmacological, herbal, multiple condoms, psychosexual treatment, prior masturbation)
• Other sexual disorder of patient or partner that could interfere with results
• Current active sexually transmitted disease
• 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
• Participation in a clinical drug trial anytime during the 30 days prior to screening
• Human Immunodeficiency Virus (HIV) or hepatitis B
• History of 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

Sponsors & Collaborators

• Ixchelsis Limited: lead
• Carelon Research: collaborator
• Novotech (Australia) Pty Limited: collaborator
• ICON plc: collaborator
• PHT Corporation: collaborator

Study Sites (10)

San Diego Sexual Medicine

San Diego, California, 92120, United States

Location

South Florida Medical Research Inc.

Aventura, Florida, 33180, United States

Location

Center for Marital and Sexual Health of South Florida

West Palm Beach, Florida, 33401, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Cooper Research Institute

Camden, New Jersey, 08103, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

Urologic Consultants of Southeastern Pennsylvania

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Miriam Hospital / The Men's Health Center

Providence, Rhode Island, 02906, United States

Location

Australian Centre for Sexual Health

Saint Leonards, New South Wales, 2065, Australia

Location

Keogh Institute for Medical Research

Nedlands, Western Australia, 6009, Australia

Location

Related Publications (1)

• McMahon C, Althof S, Rosen R, Giuliano F, Miner M, Osterloh IH, Muirhead GJ, Harty B; PEPIX Multi-Centre Study Group. The Oxytocin Antagonist Cligosiban Prolongs Intravaginal Ejaculatory Latency and Improves Patient-Reported Outcomes in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Trial (PEPIX). J Sex Med. 2019 Aug;16(8):1178-1187. doi: 10.1016/j.jsxm.2019.05.016.

  PMID: 31351659 DERIVED

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Ixchelsis Limited

ian.osterloh@ixchelsis.com

44(0)1227-832760

Study Officials

• Email Katie.George@Ixchelsis.com

  Ixchelsis Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 5, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: August 17, 2020
• Results First Posted: January 24, 2019

Record last verified: 2020-08

Locations

US (8); AU (2)