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COMPLETED Phase 2

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

NCT03055806 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 239 participants
Start Date 2017-02-28
Est. Completion 2017-12-06
Phase Phase 2

Sponsor

Ixchelsis Limited

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03055806

The ClinicalTrials.gov registry entry for NCT03055806 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 239 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ixchelsis Limited, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03055806 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Arizona, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03055806?

This trial is sponsored by Ixchelsis Limited, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial