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

Browse trials for

• Premature Birth 2,545
• Premature Ejaculation 100

Study arms

• Experimental
  Drug: IX-01

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

  Drug: IX-01

• Placebo comparator
  Placebo

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

  Drug: Placebo

Interventions

• DrugIX-01
• DrugPlacebo

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

   Time frame: Last 4 weeks of treatment compared to baseline

Secondary outcomes

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

   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 7 point scale

   Time frame: Baseline to the end of treatment (approximately 8 weeks)

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

   Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred. Outcome measured proportion of patients with at least a 2.5-fold increase in geometric mean IELT over the last 4 weeks of treatment as compared to baseline. Proportion of participants adjusted for baseline IELT, country and site

   Time frame: Last 4 weeks of treatment compared to baseline

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

   IX-01 versus placebo

   Time frame: Last 4 weeks of treatment compared to baseline

4. Mean Change in Score on Control of Timing of Ejaculation

   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)

   Time frame: Last 4 weeks of treatment compared to baseline

5. Mean Change in Score on Ejaculation-related Personal Distress

   Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.

   Time frame: Last 4 weeks of treatment compared to baseline

6. Proportion of Participants With ≥ 1 Category of Improvement in Satisfaction With Sexual Intercourse, on the Premature Ejaculation Profile (PEP) Questionnaire

   Based on Premature Ejaculation Profile (PEP) 5 point scale with the scores ranging from 0 (worse answer) to 4 (best answer).

   Time frame: Baseline to 8 weeks

7. Proportion of Participants With ≥ 1 Category of Improvement in Control Over Ejaculation During Sexual Intercourse on the Premature Ejaculation Profile (PEP) Questionnaire

   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)

   Time frame: Baseline to 8 weeks

8. Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Distress on the Premature Ejaculation Profile ( PEP) Questionnaire

   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.

   Time frame: Baseline to 8 weeks

9. Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Interpersonal Difficulty on the Premature Ejaculation Profile (PEP) Questionnaire

   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.

   Time frame: Baseline to 8 weeks

10. Proportion of Participants With ≥ 2 Category Increase in Control and ≥ 1 Category Decrease in Personal Distress on a Patient Reported Outcome (PRO) Measure

    Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Each of the PEP questions is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)

    Time frame: Baseline to 8 weeks

11. Change in Percentage of Intercourse Attempts Lasting Longer Than 1 Minute From Baseline to Last 4 Weeks on Treatment

    'Baseline' time period defined as Day -28 - Day 0. 'Last 4 Weeks' time period defined as the 28 days prior to last time subject took study drug and after Day 14. Analysis excludes two subjects from ITT population: #010-012 (placebo) and #888-018 (active). Adjusted for treatment, baseline IELT, baseline percentage, country and site.

    Time frame: Baseline to last 4 weeks on treatment

12. Incidence of Treatment-emergent Adverse Events

    Number of participants with at least one treatment-emergent adverse event

    Time frame: Start of Treatment to end of study (approximately 10 weeks)

Baseline characteristics

Publications

• 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. PubMed 31351659 ↗