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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT07236632
Eligibility Criteria:
Inclusion Criteria:
* Adult male patients aged 22 to 45 years.
* Sexually active and in a stable heterosexual relationship.
* Circumcised.
* Able to understand and comply with study procedures and follow-up visits.
* Diagnosed with lifelong drug-resistant premature ejaculation, defined as persistent ejaculation within one minute of penetration despite prior pharmacologic or behavioral therapy.
* Normal serum total testosterone, prolactin, and thyroid-stimulating hormone levels.
* Willing to provide written informed consent.
Exclusion Criteria:
* Presence or history of erectile dysfunction or other sexual or ejaculatory disorders such as retrograde ejaculation or acquired premature ejaculation.
* History of acute or chronic prostatitis.
* Any debilitating medical condition including hepatic failure, renal failure, or uncontrolled diabetes mellitus.
* Previous pelvic or spinal surgery.
* Prior chemotherapy or radiotherapy.
* Use of antipsychotic or neuroactive medications that may affect ejaculation.
* History of substance abuse or current drug dependence.
* Presence of penile prosthesis, penile deformity, or anatomic abnormalities of the glans or shaft.
* Known hypersensitivity or allergy to botulinum toxin or hyaluronic acid preparations.
* Any condition that, in the investigator's opinion, may interfere with the safety or evaluation of the study treatment.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
22 Years
Maximum Age:
45 Years
Study:
NCT07236632
Study Brief:
Protocol Section:
NCT07236632