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NCT03055806 · ClinicalTrials.gov registry record · Phase 2
IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)
A Phase 2 study of Premature Ejaculation, sponsored by Ixchelsis Limited.
- Completed
- Registry status
- Phase 2
- Development phase
- 239
- Enrollment target
- 20
- Study locations
NCT03055806: Completed Phase 2 study of Premature Ejaculation, sponsored by Ixchelsis Limited.
NCT03055806 is a Phase 2 study of Premature Ejaculation that has completed, run by Ixchelsis Limited. The registered enrollment target is 239 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03055806, a Phase 2 study of Premature Ejaculation, has completed, sponsored by Ixchelsis Limited.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 239 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG IX-01 400 mg
- DRUG IX-01 800 mg
- DRUG IX-01 1200 mg
Study Locations (20)
Florida
- South Florida Medical Research Inc. - Aventura
- A G A Clinical Trials - Hialeah
- Clinical Research Center of Florida - Pompano Beach
- Center for Marital and Sexual Health of South Florida - West Palm Beach
Arizona
- Radiant Research, Inc. - Phoenix SE - Chandler
- Desert Clinical Research, LLC - Radiant - Mesa
- Family Practice Specialists - Radiant - Phoenix
New York
- Accumed Research Associates - Garden City
- Drug Trials America - Hartsdale
- Manhattan Medical Research - New York
Massachusetts
- Boston Clinical Trials Inc - Boston
- Mens Health Boston - Chestnut Hill
Ohio
- Radiant Research, Inc. - Akron - Akron
- Radiant Research, Inc. - Cincinnati - Cincinnati
Alabama
- Coastal Clinical Research Inc - Mobile
California
- San Diego Sexual Medicine - San Diego
Colorado
- Columbine Family Practice - Radiant - Littleton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239 participants |
| Start Date | 2017-02-28 |
| Est. Completion | 2017-12-06 |
| Phase | Phase 2 |
What the finished NCT03055806 record still lists
NCT03055806 is an interventional study that assigns participants to a tested intervention. The registered 239 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher).
The record links to 1 condition, with Premature Ejaculation appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT03055806 names 20 study sites across 11 states, led by Florida, Arizona, New York.
Frequently Asked Questions
What is clinical trial NCT03055806 about?
NCT03055806 is a clinical study titled "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...
What is the current status of trial NCT03055806?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 239 participants. The study started on 2017-02-28. Estimated completion is 2017-12-06.
What conditions does trial NCT03055806 study?
This clinical trial studies the following conditions: Premature Ejaculation.
What interventions are being tested in trial NCT03055806?
The interventions under investigation include: Placebo (DRUG), IX-01 400 mg (DRUG), IX-01 800 mg (DRUG), IX-01 1200 mg (DRUG).
Who is sponsoring clinical trial NCT03055806?
This trial is sponsored by Ixchelsis Limited, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03055806 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03055806's enrollment target sits among peer trials
239 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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