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Completed

NCT Number: NCT03055806

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

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.

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Key information

Conditions

Premature Ejaculation Behavior Coitus Ejaculatory Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Behavior Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Coastal Clinical Research Inc, Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

IX-01 400 mg

Drug

IX-01 400 mg caplet

Placebo

Drug

Placebo caplet(s)

IX-01 800 mg

Drug

IX-01 800 mg (Two 400 mg caplets)

IX-01 1200 mg

Drug

IX-01 1200 mg (Three 400 mg caplets)

Primary outcomes

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

    Time frame: 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 outcomes

  1. Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline

    Time frame: 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.

  2. 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

    Time frame: 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.

  3. Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire

    Time frame: 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.

  4. 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.

    Time frame: 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'.

  5. Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 in Ejaculation-related Personal Distress on the Premature Ejaculation Profile (PEP) Questionnaire

    Time frame: 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'.

  6. 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

    Time frame: 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).

  7. Mean Change From Baseline in Score on Control of Ejaculation

    Time frame: 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).

  8. Mean Change From Baseline in Score on Ejaculation-related Personal Distress

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ixchelsis Limited

Industry

Registry information

Official study title

A Phase 2b, 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effects of 3 Different Dose Levels of IX-01 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (PE)

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 16, 2017
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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