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IX-01

Phase 2

Premature Ejaculation | Small molecule | Other |Icon Plc|Last Updated: Aug 17, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

IX-01 · 1 trial · 1 indication

Phase 2 1
NCT02232425IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)Premature Ejaculation
COMPLETED88 Analytics
PHASE2COMPLETED
IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)
Premature EjaculationUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)
Last 4 weeks of treatment compared to baseline

IX-01 versus placebo. Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred

Secondary Endpoints

Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale
Baseline to the end of treatment (approximately 8 weeks)
Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT)
Last 4 weeks of treatment compared to baseline
Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time)
Last 4 weeks of treatment compared to baseline
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Drug: IX-01EXPERIMENTALTwo to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity
PlaceboPLACEBO_COMPARATORTwo to four capsules administered orally, 1-6 hours prior to sexual activity

Interventions

NameTypeDescription
IX-01DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexMALE
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * In stable (≥ 6 months) heterosexual relationship * Have life-long (primary) premature ejaculation * Have premature ejaculation confirmed by Intravaginal Ejaculatory Latency Time (IELT) less than or equal to (≤) 1 minute on ≥ 75% attempts at sexual intercourse * Meet other aspe...

Countries:United StatesAustralia
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Frequently asked questions about IX-01

What is IX-01 used for?

IX-01 is an investigational small molecule being developed for the treatment of premature ejaculation. It is currently in Phase 2 clinical development and has been studied in a completed clinical trial to evaluate its effect on intravaginal ejaculatory latency time and patient-reported outcomes in men with this condition.

Who is developing IX-01?

IX-01 is being developed by Icon Plc, a company listed on the stock exchange under the ticker ICLR. The drug is currently in Phase 2 clinical development for the treatment of premature ejaculation.

What phase is IX-01 in?

IX-01 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy for the treatment of premature ejaculation.

What clinical trials is IX-01 in?

IX-01 has been studied in one completed clinical trial with the identifier NCT02232425. This Phase 2 trial evaluated the effect of IX-01 on intravaginal ejaculatory latency time and patient-reported outcomes in men with premature ejaculation. The trial enrolled 88 participants and was conducted in the United States and Australia.

Is IX-01 the same as any other drug?

No alternative names for IX-01 have been reported. The drug is known only by its development code IX-01 and is being studied for the treatment of premature ejaculation.