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

Ixchelsis

Status and phase: Completed; Phase 2

Conditions: Premature Ejaculation

Treatments: Drug: IX-01 800 mg; Drug: Placebo; Drug: IX-01 400 mg; Drug: IX-01 1200 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03055806

IX-0105

Details and patient eligibility

About

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.

Enrollment: 239 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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239 participants in 4 patient groups, including a placebo group

IX-01 1200 mg

Experimental group

Description:

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

Treatment:

Drug: IX-01 1200 mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

IX-01 800 mg

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: IX-01 800 mg

IX-01 400 mg

Experimental group

Description:

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

Treatment:

Drug: IX-01 400 mg

Drug: Placebo