A study comparing the benefits and adverse effects of two drugs (Clomipramine versus Dapoxetine) in treating married heterosexual men who present who ejaculate too soo

Phase 3

• Conditions: Health Condition 1: null- Premature Ejaculation

• Registration Number: CTRI/2017/09/009691
• Lead Sponsor: Christian Medical College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Married male

Has active and stable sexual relationship with wife

Age â?? 21 to 64 years

Meets DSM-5 criteria for premature ejaculation after screening

Heterosexual orientation

Speaks either of these languages â?? Hindi, Bengali, English, Tamil, Telugu, Malayalam

Agrees to have sexual intercourse at least once a week (or at least six times) over the study period

Agrees not to use study medicines more than once a day

Exclusion Criteria

Comorbid major mental illness (Psychosis, Bipolar affective disorder, Major Depressive Disorder, Obsessive compulsive disorder);

Active psychoactive substance use in dependence pattern (other than Nicotine);

Uncontrolled or Untreated medical comorbidities (Diabetes, Hypertension, Hypothyroidism, Cardiac illness, renal disease);

Current use of antipsychotic and antidepressant drugs, herbal medicines, phosphodiesterase type 5 inhibitors (for example, sildenafil);

Use of either Dapoxetine or Clomipramine in the past;

Any potential neurological, urological, or endocrine cause of PE;

Scoring 3 or 4 on first two domains, 0 or 1 on the third domain, and 0 on the fourth domain of the Premature Ejaculation Profile (PEP);

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Premature Ejaculation Profile (PEP) Scores on each domain plus Index score <br/ ><br>2. Clinical global impression of change (CGI - C)Timepoint: 1. At the end of 6 weeks <br/ ><br>2. Every week till 6 weeks

Secondary Outcome Measures

Name	Time	Method
Antidepressant Side Effects Checklist (ASEC)Timepoint: 1. At the end of 6 weeks <br/ ><br>2. Every week till 6 weeks;Discontinuation rates and reasons for discontinuationTimepoint: 1. At the end of 6 weeks <br/ ><br>2. Every week till 6 weeks