17 completed, 5 unknown, 1 recruiting. 12 Phase 3, 4 Phase 1, 2 Not applicable, 2 Phase 2, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 12 | Completed 10, Recruiting 1, Unknown 1 |
| Phase 1 | 4 | Completed 3, Unknown 1 |
| Not applicable | 2 | Completed 1, Unknown 1 |
| Phase 2 | 2 | Completed 2 |
| Phase 4 | 2 | Completed 1, Unknown 1 |
Follow dapoxetine: new trials by email Literature Review of dapoxetine trials Research Report on dapoxetine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| On-demand Silodosin 4mg vs Dapoxetine 60mg in Treatment of Primary Premature Ejaculation sildosin 4mg, dapoxetine 60mg - Premature (Early) Ejaculation | Phase 2 / Phase 3 | Completed | Benha University | 95 | 2024-03-01 | 2025-07-23 |
| The Safety of Dapoxetine/Tadalafil Combination Therapy Dapoxetine/Tadalafil 30/20 mg film coated tablet - Premature Ejaculation, Erectile Dysfunction | Phase 4 | Unknown | Neutec Ar-Ge San ve Tic A.Ş | 40 | 2022-12-31 | 2022-05-17 |
| Effectiveness and Safety of TENS Therapy for Premature Ejaculation Tens therapy, Dapoxetine placebo, Standard treatment (dapoxetine 30 mg as needed) - Premature Ejaculation, Sex Disorder | Phase 3 | Recruiting | Boston Medical Group | 129 | 2022-06-15 | 2024-05-22 |
| Observational Study of Pharmacological Treatment for Premature Ejaculation Concurrent With Erectile Dysfunction Dapoxetine, Tadalafil - Premature Ejaculation, Erectile Dysfunction | Phase 3 | Unknown | Yan-Ping Huang | 150 | 2020-06-03 | 2020-04-24 |
| 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 Multi-Vitamin Tablets, Dapoxetine, Dapoxetine and folic acid. - Premature Ejaculation | Phase 3 | Completed | Sohag University | 120 | 2019-02-10 | 2019-09-11 |
| Investigation of the Changes of Brain Structure and Function in Premature Ejaculation Patients and the Effects of Dapoxetine on Central Neural Activity in Premature Ejaculation Patients Dapoxetine Hydrochloride Tablet, Placebo Tablet - Premature Ejaculation | Not applicable | Unknown | Xidian University | 100 | 2018-07-10 | 2018-08-24 |
| Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation Dapoxetine - Premature Ejaculation | Unknown | Pusan National University Hospital | 200 | 2017-01-01 | 2017-01-12 | |
| The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy Dapoxetine/Sildenafil 30/50 mg film coated tablet - Premature Ejaculation, Erectile Dysfunction | Phase 4 | Completed | Neutec Ar-Ge San ve Tic A.Ş | 75 | 2016-10-01 | 2019-05-20 |
| The Impact and Benefit of Physical Activity on Premature Ejaculation physical activity, dapoxetine 30 mg on demand - Premature Ejaculation | Not applicable | Completed | Ankara Training and Research Hospital | 120 | 2015-01-01 | 2017-09-29 |
| Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 100mg Dapoxetine 30mg, Mirodenafil 100mg - Drug Interaction Potentiation | Phase 1 | Completed | SK Chemicals Co., Ltd. | 36 | 2014-11-01 | 2015-06-30 |
| Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 50mg Dapoxetine 30mg tablet, Mirodenafil 50mg tablet - Drug Interaction Potentiation | Phase 1 | Completed | SK Chemicals Co., Ltd. | 36 | 2013-10-01 | 2015-06-30 |
| Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine Dapoxetine, Udenafil, Udenafil+Dapoxetine - Healthy Male Subjects | Phase 1 | Unknown | Dong-A Pharmaceutical Co., Ltd. | 24 | 2013-09-01 | 2013-08-26 |
| Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044 dapoxetine - Premature Ejaculation | Phase 1 / Phase 2 | Completed | Yuhan Corporation | 24 | 2011-02-01 | 2012-08-01 |
| The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy Dapoxetine - Sexual Dysfunction, Physiological | Phase 3 | Completed | Janssen Research & Development, LLC | 285 | 2010-05-22 | 2024-11-19 |
| Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction Placebo, Dapoxetine, PDE5I (phosphodiesterase-5 inhibitor) - Erectile Dysfunction, Sexual Dysfunction | Phase 3 | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 495 | 2010-04-01 | 2013-01-24 |
| PRILIGY Usage Patterns in Selected Populations PRILIGY (dapoxetine hydrochloride) - Sexual Dysfunction, Physiological | Completed | Janssen Research & Development, LLC | 3000 | 2010-01-01 | 2014-04-08 | |
| An Observational Study of Men With Premature Ejaculation Who Are Treated With Dapoxetine Hydrochloride or Alternate Care Defined as Any Treatment Other Than Dapoxetine Hydrochloride Dapoxetine hydrochloride, Alternate care/non-dapoxetine hydrochloride treatment(s) - Sexual Dysfunction, Physiological, Ejaculation | Completed | Janssen Research & Development, LLC | 10027 | 2009-09-01 | 2013-11-26 | |
| A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation Dapoxetine - Erectile Dysfunction | Phase 3 | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 1067 | 2005-03-01 | 2011-06-08 |
| A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation dapoxetine - Erectile Dysfunction | Phase 3 | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 1116 | 2004-12-01 | 2011-06-08 |
| A Study of Withdrawal Effects With Dapoxetine in the Treatment of Premature Ejaculation Dapoxetine - Sexual Dysfunction, Ejaculation | Phase 3 | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 199 | 2004-11-01 | 2011-06-08 |
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Premature Ejaculation (20) · Sexual Dysfunction, Physiological (11) · Erectile Dysfunction (7) · Coitus (6) · Sexual Dysfunctions, Psychological (6) · Premature Birth (1)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (4) · Alza Corporation, DE, USA (3) · Janssen Research & Development, LLC (3) · Neutec Ar-Ge San ve Tic A.Ş (2) · SK Chemicals Co., Ltd. (2) · Ankara Training and Research Hospital (1) · Benha University (1) · Boston Medical Group (1) · Dong-A Pharmaceutical Co., Ltd. (1) · Pusan National University Hospital (1) · Sohag University (1) · Xidian University (1) · Yan-Ping Huang (1) · Yuhan Corporation (1)
South Korea (5) · Australia (2) · Egypt (2) · Mexico (2) · Turkey (Türkiye) (2) · Argentina (1) · Austria (1) · Belgium (1) · Canada (1) · China (1) · Finland (1) · France (1) · Germany (1) · Malaysia (1) · Poland (1)
Jae-Wook Ko, MD, PhD (1) · Jorge Barba, MD (1) · Kyun-Seop Bae, M.D., Ph.D. (1) · Min-Gul Kim, MD, PhD (1) · Mohammed Abu El-Hamd, MD (1)
PMID 21059176, PMID 16962882, PMID 20412423, PMID 19195772, PMID 19878447, PMID 20367770, PMID 23845016, PMID 30705437
2009 (1)