Health Condition 1: N528- Other male erectile dysfunction
Conditions
Interventions
Intervention1: LipidUp-PE: Daily 2 sachets mix in 200ml of water
Control Intervention1: Placebo: Daily 2 sachets mix in 200ml of water
Sponsors
MMC Pharmaceuticals Ltd
SRM Medical College Hospital and Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: Subjects meeting with diagnostic criteria for Premature Ejaculation (PE score greater than or equal to 11). Subjects must be in a stable, monogamous, sexual relationship with the same partner for at least 6 months and plan to maintain this relationship for the duration of the trial. Subjects with intravaginal ejaculatory latency time (IELT) of � 2 minutes. Subjects who are willing to sign informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: ïâ??§Subjects with genital anatomical deformities including but not limited to penile deformities. ïâ??§Use of any investigational drug within the past month ïâ??§Subjects with major psychiatric illness or previous suicidal attempts. ïâ??§Subjects with history of epilepsy ïâ??§Subjects with alcohol abuse, dependence, smoking addiction, and on any other drugs which can interfere with ejaculation can be excluded ïâ??§Subjects with significant and uncontrolled hematological /metabolic/ endocrinologial/ respiratory/ cardiovascular/ neurological/psychiatric/liver/ gastrointestinal/kidney diseases or other significant pathological conditions which is judged by Investigator may affect subject participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of LipidUp-PE on Serotonin (5-hydroxytryptamine, 5-HT) in subjects with premature ejaculation.Timepoint: First response rate can be measured at 1st week from the day of the therapy for 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of LipidUp-PE on IntravaginalEjaculatory Latency Time (IELT) and Premature Ejaculation Diagnostic Tool (PEDT) scores in subjects with premature ejaculation.Timepoint: At Initial and after 12th Week | — |
Countries
India
Contacts
Public ContactDr RC Satish Kumar
SRM Institute of Science and Technology
Outcome results
None listed