IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)
Public ClinicalTrials.gov record NCT03055806. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2b, 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effects of 3 Different Dose Levels of IX-01 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (PE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03055806
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 239 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2017 (Actual)
- Primary completion
- Nov 17, 2017 (Actual)
- Completion
- Dec 6, 2017 (Actual)
- Last update posted
- Oct 7, 2019
2017
United States locations
- U.S. sites
- 29
- U.S. states
- 16
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Coastal Clinical Research Inc | Mobile | Alabama | 36608 | — |
| Radiant Research, Inc. - Phoenix SE | Chandler | Arizona | 85224 | — |
| Desert Clinical Research, LLC - Radiant | Mesa | Arizona | 85213 | — |
| Family Practice Specialists - Radiant | Phoenix | Arizona | 85018 | — |
| San Diego Sexual Medicine | San Diego | California | 92120 | — |
| Columbine Family Practice - Radiant | Littleton | Colorado | 80128 | — |
| South Florida Medical Research Inc. | Aventura | Florida | 33180 | — |
| A G A Clinical Trials | Hialeah | Florida | 33012 | — |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | — |
| Center for Marital and Sexual Health of South Florida | West Palm Beach | Florida | 33401 | — |
| Northwest Behavioral Research Center | Roswell | Georgia | 30076 | — |
| Boston Clinical Trials Inc | Boston | Massachusetts | 02131 | — |
| Mens Health Boston | Chestnut Hill | Massachusetts | 02467 | — |
| Center For Pharmaceutical Research | Kansas City | Missouri | 64114 | — |
| Clifford J Molin MD LTD - Radiant | Las Vegas | Nevada | 89128 | — |
| Accumed Research Associates | Garden City | New York | 11530-1664 | — |
| Drug Trials America | Hartsdale | New York | 10530 | — |
| Manhattan Medical Research | New York | New York | 10016 | — |
| Radiant Research, Inc. - Akron | Akron | Ohio | 44311 | — |
| Radiant Research, Inc. - Cincinnati | Cincinnati | Ohio | 45236 | — |
| Radiant Research, Inc. - Columbus | Columbus | Ohio | 43212 | — |
| Urologic Consultants of Southeastern Pennsylvania | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Miriam Hospital / The Men's Health Center | Providence | Rhode Island | 02906 | — |
| Radiant Research, Inc. - Anderson | Anderson | South Carolina | 29621 | — |
| Radiant Research, Inc. - Greer | Greer | South Carolina | 29650 | — |
| Radiant Research, Inc. - Dallas | Dallas | Texas | 75231 | — |
| Clinical Trials of Texas Incorporated | San Antonio | Texas | 78229 | — |
| Radiant Research Inc - San Antonio | San Antonio | Texas | 78229 | — |
| Radiant Research, Inc. - Salt Lake City | Murray | Utah | 84123 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03055806, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 7, 2019 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03055806 live on ClinicalTrials.gov.