Health Condition 1: N531- Ejaculatory dysfunction Health Condition 2: null- Premature Ejaculation
Conditions
Interventions
Intervention1: Dapoxetine 30 mg tablets: 1 to 3 hours before anticipated sexual intercourse for 2 weeks
Control Intervention1: Matching Placebo tablets: 1 to 3 hours before anticipated sexual intercou
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male patients of 18 to 60 years of age. 2. Stable, monogamous sexual relationship with a female partner 3. Established diagnosis of premature ejaculation (PE) 4. Informed consent
Exclusion criteria
Exclusion criteria: 1. Erectile dysfunction or other forms of sexual dysfunction. 2. Patients whose partners have problems of self-reported sexual dysfunction. 3. History of major psychiatric disorder. 4. Other significant pathological cardiac conditions 5. Concomitant treatment which is not permissible 6. History of orthostatic hypotension, seizures, lactose intolerance, hepatic or renal impairment. 7. Patients with known hypersensitivity to SSRIs. 8. Patients with any other serious concurrent illness or malignancy. 9. Patients with continuing history of alcohol and / or drug abuse. 10. Participation in another clinical trial in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the Premature Ejaculation Profile (PEP) scoreTimepoint: 0, 1 & 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change in individual measures of PEP 2. Patient rating of severity of PE 3. Patients global impression of changeTimepoint: 0, 1 & 2 weeks | — |
Countries
India
Contacts
Public ContactDr Ravindra Mittal
Cadila Healthcare Ltd.
Outcome results
None listed