Health Condition 1: null- Premature Ejaculation
Conditions
Interventions
Intervention1: OLNP-05: One capsule of 500mg Twice daily
Control Intervention1: Placebo: One capsule of 500mg Twice daily
Sponsors
Olene Life Sciences Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male subjects, aged >= 21 years to 2. Subject having a monogamous, heterosexual relationship and expected/planned to maintain this relationship for the duration of study 3. Subjects having baseline Intravaginal Ejaculatory Latency Time (IELT) of 4. Subjects meeting with diagnostic criteria for premature ejaculation (PEP score >=11) 5. Subject and his partner agreeing to attempt sexual intercourse 2 times/ week and to use stopwatch during the intercourse 6. Subject willing to give written informed consent and willing to comply with trial protocol
Exclusion criteria
Exclusion criteria: 1. Previous events or other conditions that may affect premature ejaculation/erectile dysfunction, including but not limited to spinal trauma or pelvic surgery 2. Subjects with genital anatomical deformities including but not limited to penile deformities 3. Subjects for whom sexual activity is inadvisable because of their underlying disease status. 4. Sexual dysfunction in female partner, painful intercourse, partners with decreased interest in intercourse or other forms of sexual dysfunction. 5. Subjects with significant and uncontrolled hematological /metabolic/ endocrinologial/ respiratory/ cardiovascular/ neurological/psychiatric/liver/ gastrointestinal/kidney diseases or other significant pathological conditions which as judged by Invesutigator may affect subject participation in the study 6. Any concomitant treatment which is not permissible 7. Continuing history of alcohol and / or drug abuse 8. Recent participation in another clinical trial or receive some other drug during the study besides that in the protocol that known to alter the pharmacokinetics/pharmacodynamic profile of the study drug. 9. Subject having a known allergy to any of the ingredients of investigational prodcut 10. Any other condition that in the opinion of the Investigator does not justify the subjectâ??s participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change from baseline in Intravaginal Ejaculatory Latency Time (IELT)Timepoint: Screening visit, Visit 3 (Day 28) and Visit 4 (Day 56) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global impression- Improvement from visit-3 to visit 4Timepoint: Visit 3 (Day 28) and Visit 4 (Day 56);Mean change from baseline in Improvement in individual parameters of premature ejaculation profile (PEP) scoresTimepoint: Screening visit, Visit 3 (Day 28) and Visit 4 (Day 56);Mean change in PEP Index score (Mean of all four measures)Timepoint: Screening visit, Visit 3 (Day 28) and Visit 4 (Day 56) | — |
Countries
India
Contacts
Public ContactMr Sanjib panda
Olene Life Sciences Private Limited
Outcome results
None listed