Health Condition 1: N531- Ejaculatory dysfunction
Conditions
Interventions
None listed
Sponsors
Pontika Aerotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Informed consent for subjects and partners 2.Men 20-60 years of age 3.Stable monogamous relation at least for 6 months 4.Premature Ejaculation Diagnosis Tool (PEDT) score of less than 9. 5.At least 6 months of premature ejaculation History 6.IELT (Intravaginal ejaculation latency time) of 2 min and more than 75% of evaluable events during 4 week screening period
Exclusion criteria
Exclusion criteria: 1.History of medical or psychiatric illness 2.Erectile dysfunction (21 International Index of Erectile Function-Erectile Function (IIEF-EF) domain score) or other forms of sexual dysfunction 3.Partner sexual dysfunction 4.Known hypersensitivity to the ingredients of the test product. 5.Any known, clinically significant, systemic disease in addition to the trial indication that might negatively impact the study outcome. 6.History of drug or alcohol abuse during the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Intravaginal ejaculation latency time (IELT) 2. Sexual satisfaction will be assessed using a Likert scale. 3. PEDT and AIPE score before and after the treatment of 4 weeks. Timepoint: Baseline and 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical safety assessments, including weight, blood pressure, pulse and adverse eventsTimepoint: Baseline and 4 weeks | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Grace Trinity Hospital
Outcome results
None listed