Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT07047404
Eligibility Criteria:
Inclusion Criteria:
* Males aged 18 to 50 years old (both inclusive)
* Diagnosis of primary (lifelong) PE according to the investigator
* Intravaginal Ejaculatory Latency Time (IELT) estimated by the patient around one (1) minute at screening
* Confirmation at randomization visit that at least 3 timed sexual intercourses with each IELT below 90 seconds occurred during the baseline period
* Patient must be able to provide an informed consent and voluntarily express a willingness to participate in this study, and must sign and date an informed consent prior to any study specific procedure
* Capability to participate in all study tests according to the investigator
Exclusion Criteria:
* Diagnosis of acquired PE, pseudo-PE or natural variable PE
* History of clinically significant abnormalities comprising cardiovascular (including especially prolonged QTc (\>450 ms) and high degree (second and third) atrio-ventricular blocks)), hematological, neurological, and endocrine diseases
* Current therapy with any treatment which may impact PE from 4 weeks prior to the screening visit
* Current therapy with any treatment displaying dopamine D3 receptor agonist properties from 4 weeks prior to the screening visit
* Concomitant intake of psychoactive / chem-sex substances
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07047404
Study Brief:
Protocol Section:
NCT07047404