Health Condition 1: null- Premature Ejaculation
Conditions
Interventions
Intervention1: Tab. Clomipramine Hydrochloride and Psychoeducation: Oral clomipramine (25 mg daily for 1st week and 25-50 mg for subsequent 5 weeks, depending on participantsâ?? preference).
Psycho-e
Sponsors
Christian Medical College
Eligibility
Inclusion criteria
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
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);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Premature Ejaculation Profile (PEP) Scores on each domain plus Index score 2. Clinical global impression of change (CGI - C)Timepoint: 1. At the end of 6 weeks 2. Every week till 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Antidepressant Side Effects Checklist (ASEC)Timepoint: 1. At the end of 6 weeks 2. Every week till 6 weeks;Discontinuation rates and reasons for discontinuationTimepoint: 1. At the end of 6 weeks 2. Every week till 6 weeks | — |
Countries
India
Contacts
Public ContactDr Saumil Dholakia
Christian Medical College
Outcome results
None listed