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Premature ejaculation (PE) is a common disease in the andrology clinic. Currently, the effectiveness and outcome differences of drug treatment still need to be studied and demonstrated. Premature ejaculation concurrent with erectile dysfunction (ED) is common in outpatient clinics. The preferred treatment plan for these patients still needs to be further studied and explored, and the difference in the efficacy of different treatment regiments remain to be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tadalafil combined with dapoxetine | Experimental |
| |
| tadalafil mono group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapoxetine | Drug | 30 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 8 weeks Tadalafil 5 mg tablets every day for 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change of Premature Ejaculation Profile (PEP) at week 8 | The PEP is a 4-question PRO that asks a respondent about his subjective sense of control over ejaculation, distress related to PE, interpersonal difficulty and satisfaction with sexual intercourse. | Baseline, Week 8 |
| The change of International Index of Erectile Function -5(IIEF-5) at week 8 | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions | To observe the safety of the two regiments in PE concurrent with ED patients | Baseline, Week 8 |
| The change of Erection Hardness Score (EHS) | Erection Hardness Score as a self-reporting measure that scored erection hardness on a 4 point scale. The aim was to help men, their partners and doctors diagnose erectile dysfunction. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D061686 | Premature Ejaculation |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C080598 | dapoxetine |
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Tadalafil | Drug | 5 mg tablets every day for 8 weeks |
|
| Tadalafil | Drug | 5 mg tablets every day for 8 weeks |
|
| Baseline, Week 8 |
| Clinical Global Impression of Change (GICC) | Clinical Global Impression is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. | Baseline, Week 8 |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |