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NCT04085354: PE
Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation
Phase 3 trial testing Multi-Vitamin Tablets in Premature Ejaculation in 120 participants. Completed in 29 August 2019.
1 June 2019
Quick facts
| Lead sponsor | Sohag University |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 10 February 2019 |
| Primary completion | 1 June 2019 |
| Estimated completion | 29 August 2019 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Multi-Vitamin Tablets — full drug profile →
- Dapoxetine (DAPOXETINE) — full drug profile →
- Dapoxetine and folic acid. — full drug profile →
- Dapoxetine and vitamin B12 — full drug profile →
Conditions studied
- Premature Ejaculation — all drugs for Premature Ejaculation →
Sponsor
Sohag University
Who can join
Adults 20 to 50, male only, with Premature Ejaculation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will aim to assess of the clinical efficacy and safety of dapoxetine, combined dapoxetine with folic acid and combined dapoxetine with vitamin B12 in treatment of patients with premature ejaculation: A randomized placebo-controlled clinical trial.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04085354
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Premature Ejaculation
Currently open trials in the same condition.
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- NCT07434271 — Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outc · Phase 2 · recruiting
- NCT06570135 — Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial · NA · recruiting
- NCT06851598 — Safety and Efficacy of Botulinum Toxin-A Injection Into Ischiocavernosus Muscle for Premature Ejaculation · Phase 2, PHASE3 · active not recruiting
- NCT06605469 — Ejaculatory and Orgasmic Dysfunction Registry · recruiting
Other Sohag University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04085354 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sohag University
- Last refreshed: 11 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04085354.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing