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

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ClinicalTrials.gov Identifier: NCT03055806
Recruitment Status : Completed
First Posted : February 16, 2017
Results First Posted : October 7, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Ixchelsis Limited

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.


Condition or disease Intervention/treatment Phase
Premature Ejaculation Drug: IX-01 400 mg Drug: Placebo Drug: IX-01 800 mg Drug: IX-01 1200 mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : February 28, 2017
Actual Primary Completion Date : November 17, 2017
Actual Study Completion Date : December 6, 2017

Arm Intervention/treatment
Experimental: 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
Drug: IX-01 1200 mg
IX-01 1200 mg (Three 400 mg caplets)

Placebo Comparator: Placebo
Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Drug: Placebo
Placebo caplet(s)

Experimental: 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
Drug: Placebo
Placebo caplet(s)

Drug: IX-01 800 mg
IX-01 800 mg (Two 400 mg caplets)

Experimental: 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
Drug: IX-01 400 mg
IX-01 400 mg caplet

Drug: Placebo
Placebo caplet(s)




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men aged ≥18 years and ≤60 years in stable (≥6 months) heterosexual relationship and who have lifelong PE.
  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:

  1. IELT value >2 minutes during the run-in period.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055806


Locations
Show Show 29 study locations
Sponsors and Collaborators
Ixchelsis Limited
  Study Documents (Full-Text)

Documents provided by Ixchelsis Limited:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ixchelsis Limited
ClinicalTrials.gov Identifier: NCT03055806    
Other Study ID Numbers: IX-0105
First Posted: February 16, 2017    Key Record Dates
Results First Posted: October 7, 2019
Last Update Posted: October 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ixchelsis Limited:
Sex
Sexual Dysfunction
IX-01
Additional relevant MeSH terms:
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Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders