This study evaluates the effectiveness and safety of a product in helping men with premature ejaculation last longer during intercourse.

Phase 2/3

Not yet recruiting

• Conditions: Ejaculatory dysfunction. Ayurveda Condition: SUKRAGATAVATAH,

• Registration Number: CTRI/2025/03/082740
• Lead Sponsor: Pontika Aerotech Limited

Brief Summary

The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study.

25 subjects diagnosed with Premature Ejaculation and satisfying selection criteria, will be enrolled in the study in a single group.

Test Group– **NATUREASE SPRAY**: 25 subjects : For 4 weeks. Massage 2-6 sprays into the head and shaft of the penis depending on your sensitivity. Apply minimum of ten minutes before intercourse over a period of 4 weeks as per requirement.

Subjects will be asked to visit clinical facility/institution for their follow up at week, 2 and 4 weeks for assessment of outcome parameters.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-30
• Last Update Posted: 2025-06-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Male
• Target Recruitment: 25

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Intravaginal ejaculation latency time (IELT)	Baseline and 4 weeks
2. Sexual satisfaction will be assessed using a Likert scale.	Baseline and 4 weeks
3. PEDT and AIPE score before and after the treatment of 4 weeks.	Baseline and 4 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical safety assessments, including weight, blood pressure, pulse and adverse events	Baseline and 4 weeks

Trial Locations

Locations (2)

Grace Trinity Hospital; 🇮🇳 Vellore, TAMIL NADU, India

PM Medical Centre; 🇮🇳 Vellore, TAMIL NADU, India

Grace Trinity Hospital

🇮🇳Vellore, TAMIL NADU, India

Dr Ramesh Kanna

Principal investigator

09677786774

srkguruvarshan@gmail.com