A clinical trial to study the effects of Dapoxetine tablets in patients suffering from premature ejaculatio
- Conditions
- Health Condition 1: N531- Ejaculatory dysfunctionHealth Condition 2: null- Premature Ejaculation
- Registration Number
- CTRI/2010/091/001118
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change in the Premature Ejaculation Profile (PEP) scoreTimepoint: 0, 1 & 2 weeks
- Secondary Outcome Measures
Name Time Method 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