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

NCT03055806 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IX-0105
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 29

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.

Conditions

Premature Ejaculation

Keywords

Sex; Sexual Dysfunction; IX-01

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period

  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.

  Last 4 weeks of treatment compared to baseline

Secondary Outcomes (8)

• 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

• 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

• 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)

• 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)

• 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)

Study Arms (4)

IX-01 1200 mg

EXPERIMENTAL

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

Drug: IX-01 1200 mg

Placebo

PLACEBO COMPARATOR

Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity

Drug: Placebo

IX-01 800 mg

EXPERIMENTAL

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

Drug: Placebo; Drug: IX-01 800 mg

IX-01 400 mg

EXPERIMENTAL

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

Drug: IX-01 400 mg; Drug: Placebo

Interventions

IX-01 400 mg DRUG

IX-01 400 mg caplet

IX-01 400 mg

Placebo DRUG

Placebo caplet(s)

IX-01 400 mg; IX-01 800 mg; Placebo

IX-01 800 mg DRUG

IX-01 800 mg (Two 400 mg caplets)

IX-01 800 mg

IX-01 1200 mg DRUG

IX-01 1200 mg (Three 400 mg caplets)

IX-01 1200 mg

Eligibility Criteria

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

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.

Sponsors & Collaborators

• Ixchelsis Limited: lead

Study Sites (29)

Coastal Clinical Research Inc

Mobile, Alabama, 36608, United States

Location

Radiant Research, Inc. - Phoenix SE

Chandler, Arizona, 85224, United States

Location

Desert Clinical Research, LLC - Radiant

Mesa, Arizona, 85213, United States

Location

Family Practice Specialists - Radiant

Phoenix, Arizona, 85018, United States

Location

San Diego Sexual Medicine

San Diego, California, 92120, United States

Location

Columbine Family Practice - Radiant

Littleton, Colorado, 80128, United States

Location

South Florida Medical Research Inc.

Aventura, Florida, 33180, United States

Location

A G A Clinical Trials

Hialeah, Florida, 33012, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Center for Marital and Sexual Health of South Florida

West Palm Beach, Florida, 33401, United States

Location

Northwest Behavioral Research Center

Roswell, Georgia, 30076, United States

Location

Boston Clinical Trials Inc

Boston, Massachusetts, 02131, United States

Location

Mens Health Boston

Chestnut Hill, Massachusetts, 02467, United States

Location

Center For Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Clifford J Molin MD LTD - Radiant

Las Vegas, Nevada, 89128, United States

Location

Accumed Research Associates

Garden City, New York, 11530-1664, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

Radiant Research, Inc. - Akron

Akron, Ohio, 44311, United States

Location

Radiant Research, Inc. - Cincinnati

Cincinnati, Ohio, 45236, United States

Location

Radiant Research, Inc. - Columbus

Columbus, Ohio, 43212, 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

Radiant Research, Inc. - Anderson

Anderson, South Carolina, 29621, United States

Location

Radiant Research, Inc. - Greer

Greer, South Carolina, 29650, United States

Location

Radiant Research, Inc. - Dallas

Dallas, Texas, 75231, United States

Location

Clinical Trials of Texas Incorporated

San Antonio, Texas, 78229, United States

Location

Radiant Research Inc - San Antonio

San Antonio, Texas, 78229, United States

Location

Radiant Research, Inc. - Salt Lake City

Murray, Utah, 84123, United States

Location

Related Publications (1)

• 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.

  PMID: 31351660 DERIVED

MeSH Terms

Conditions

Premature Ejaculation; Coitus; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Ixchelsis Limited

ian.osterloh@ixchelsis.com

44 (0) 1227-832760

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: February 14, 2017
• First Posted: February 16, 2017
• Study Start: February 28, 2017
• Primary Completion: November 17, 2017
• Study Completion: December 6, 2017
• Last Updated: October 7, 2019
• Results First Posted: October 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (29)