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CTRI Number  CTRI/2025/12/099116 [Registered on: 15/12/2025] Trial Registered Prospectively
Last Modified On: 28/09/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Study in male participants to assess how safe benzocaine condoms are and how well they help in controlling ejaculation. 
Scientific Title of Study   A prospective, non-randomized clinical study comparing the clinical safety, performance and ejaculatory control effect of benzocaine-containing natural rubber latex male condoms. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
DKR-PS-KRX-01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Gopinath 
Designation  Consultant Urologist 
Affiliation  Sudha Hospitals,Erode,Tamil Nadu 
Address  Ground Floor, Room No.3 162, SIMS (SUDHA) hospital, 181, Perundurai Rd, Edayankattuvalasu, Erode

Erode
TAMIL NADU
638011
India 
Phone  9894418652  
Fax    
Email  drgopinathms@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Gopinath 
Designation  Consultant Urologist 
Affiliation  Sudha Hospitals,Erode,Tamil Nadu 
Address  Ground Floor, Room No.3 162, SIMS (SUDHA) hospital, 181, Perundurai Rd, Edayankattuvalasu, Erode

Erode
TAMIL NADU
638011
India 
Phone  9894418652  
Fax    
Email  drgopinathms@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M Gopinath 
Designation  Consultant Urologist 
Affiliation  Sudha Hospitals,Erode,Tamil Nadu 
Address  Ground Floor, Room No.3 162, SIMS (SUDHA) hospital, 181, Perundurai Rd, Edayankattuvalasu, Erode

Erode
TAMIL NADU
638011
India 
Phone  9894418652  
Fax    
Email  drgopinathms@gmail.com  
 
Source of Monetary or Material Support  
Karex Industries Sdn. Bhd. PTD 7906 & 7907, Taman Pontian Jaya, Batu 34, Jalan Johor, 82000 Pontian, Johor Darul Takzim, Malaysia 
 
Primary Sponsor  
Name  Karex Industries Sdn. Bhd. 
Address  PTD 7906 & 7907, Taman Pontian Jaya, Batu 34, Jalan Johor, 82000 Pontian, Johor Darul Takzim, Malaysia 
Type of Sponsor  Other [Medical device manufacturer] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kumaraswamy  S.C.S Hospital   Ground Floor, Room No.: 2 S.C.S Hospital(Near Govt. Hospital) 466, Brough Rd, Erode Fort, Erode
Erode
TAMIL NADU 		 9842726272

drgurujierode@gmail.com 
Dr M Gopinath  Sudha Hospitals   Urology Department, Ground Floor, Room No.: 3 Sudha Hospitals 162, SIMS (SUDHA) hospital, 181, Perundurai Rd, Edayankattuvalasu, Erode
Erode
TAMIL NADU 		 9894418652

drgopinathms@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee,Sudha Hospital  Approved 
Institutional Ethics Committee,Sudha Hospital  Approved 
Institutional Ethics Committee,Sudha Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F524||Premature ejaculation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Natural Rubber Latex Male Condoms with Benzocaine Lubricant  Condom is a non-sterile, single use device made of natural rubber latex, lubricated with silicone oil and water-soluble lubricant containing benzocaine, a common over-the-counter drug. It is used for contraceptive and prophylactic purposes to help prevent pregnancy and transmission of sexually transmitted infections. In addition, the male genital desensitizer lubricant (benzocaine gel) on the condom surface in contact with the male penis that helps in temporarily prolonging the time until ejaculation. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  Participants are eligible for inclusion if all of the following criteria are met
1.Male aged 18 to 45 years, circumcised or uncircumcised.
2.In a mutually monogamous heterosexual relationship of at least 3 months duration.
3.Engaged in regular penile-vaginal sexual activity sufficient to meet protocol-defined minimum coital frequency.
4.Willing to have penile-vaginal intercourse using only study-provided condoms for the duration of the study.
5.Partner is currently using a reliable method of contraception (e.g oral contraceptive pills intrauterine device contraceptive patch or injection or either partner has undergone sterilization).
6.Willing to use only the lubricants provided by the study.
7.Willing to avoid the use of drugs medications, or non-study devices that may affect sexual performance during the study period.
8.Able to understand and follow instructions regarding correct condom usage and study protocol.
9.Willing to remove any genital piercing jewelry prior to condom use during the study period.
10.No known sexually transmitted infections STIs including HIV/AIDS at baseline.
11.Willing and able to provide informed consent, participate in interviews and complete self-administered questionnaires.
12.Available for follow-up throughout the study duration. 
 
ExclusionCriteria 
Details  Participants will be excluded from the study if any of the following conditions apply (to either participant or partner)
1.Known allergy or sensitivity to any components of the test or control condoms including natural rubber latex or benzocaine.
2.Known hypersensitivity to local anesthetics of the ester type including procaine, lidocaine, tetracaine, or other caine drugs.
3.Presence of any of the following medical conditions
i Heart arrhythmias
ii Methemoglobinemia (history or predisposition)
iii Glucose-6-phosphate dehydrogenase (G6PD) deficiency
iv Chronic Obstructive Pulmonary Disease (COPD), emphysema, or coronary artery disease
4.Pregnancy or desire to become pregnant during the study period (female partner).
5.Known sexually transmitted infection in the male or female partner at the time of enrolment
6.Male partner has known erectile dysfunction
Male partner has known ejaculatory dysfunction like delayed ejaculation (difficulty or delay to ejaculate despite adequate stimulation and arousal) retrograde ejaculation (semen flows backward into the bladder instead of out through the urethra) anorgasmia or anejaculation (complete absence of ejaculation)
7.Participants engaging in penile-oral sex or penile-anal sex during the study period
8.Participants using any oral supplements or topical treatments on the penis intended to delay ejaculation.
9.Either partner is a commercial sex worker.
10.Participants with itinerant lifestyles or occupations (e.g. migrant workers) that prevent completion of the study.
11.Use of any topical or intravaginal medication/preparation applied to the genitalia (except study-provided materials).
12.Either partner is an employee of the study sponsor or otherwise affiliated with the clinical research center. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To monitor and document discomfort potentially attributable to the benzocaine-containing condom, including:
oLocal side effects: Pain, stinging or burning sensation, constriction/tightness, tingling
oDermatological reactions: skin irritation, erythema, rash, swelling, genital itching, dryness
oSystemic reactions: dizziness, drowsiness (especially with prolonged exposure)
oPartner-related effects: numbness in partner’s genital area 		 Three follow-up visits:
1.Visit 1: After using five control condoms (A)
2.Visit 2: After using the 1st five study condoms (B or C)
3.Visit 3: After using the 2nd five study condoms (C or B) 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the incidence of adverse events, including:
oAllergic reactions: latex or benzocaine hypersensitivity, including urticaria or anaphylaxis
oMethemoglobinemia: characterized by cyanosis, difficulty breathing (e.g., blue lips)
oInfections: occurrence of post-use urinary tract infections or vulvovaginal candidiasis 		 Three follow-up visits:
1.Visit 1: After using five control condoms (A)
2.Visit 2: After using the 1st five study condoms (B or C)
3.Visit 3: After using the 2nd five study condoms (C or B) 
 
Target Sample Size   Total Sample Size="480"
Sample Size from India="480" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Primary Objective:
To evaluate the effect of benzocaine condoms (8.5% benzocaine gel) on Intravaginal Ejaculatory Latency Time (IELT).
Secondary Objectives:
•To compare the mechanical performance of benzocaine-containing condoms with standard condoms, by assessing:
1.Clinical breakage rates (condom breakage during intercourse)
2.Clinical slippage rates (condom dislodgement during intercourse)
3.Non-clinical breakage and slippage (e.g., during donning, withdrawal, or post-use inspection)
•To assess user-reported outcomes, including:
1.Overall satisfaction with the product
2.Perceived ease of use
3.Sexual experience (including sensation, arousal, and orgasm quality)
4.Willingness to continue or recommend the product
5.To explore potential clinical benefits, such as:
6.Enhanced ejaculatory control
7.Reduced performance anxiety
8.Improved partner sexual satisfaction (if assessed).

Number of subjects-
The clinical study is designed to include a total of 480 couples, with 240 couples involving circumcised males and 240 involving uncircumcised males.

Study Design-
This study is designed as a prospective, interventional, multi-centric, non-randomized, open-label, single-arm comparative clinical study designed to evaluate the effect of benzocaine-containing condoms (8.5% benzocaine gel) on intravaginal ejaculatory latency time (IELT), along with their safety, performance and user acceptability.
Heterosexual couples meeting the eligibility criteria will be enrolled upon obtaining informed consent from both the participant and their partner. Participants will be provided with a document titled ’Instructions for Participants’ (Attachment V), which outlines the instructions for use and details of the study.
Participants will have to use a total of 15 condoms, five each of Control Condom A (P53S without Benzocaine), Test Condom B (P53S with 8.5% Benzocaine) and Test Condom C (T56S with 8.5% Benzocaine). The control product will be used first, followed by the test products. There should be an interval of at least 24 hours between the use of each condom.
Participants will be instructed to measure the Intravaginal Ejaculatory Latency Time (IELT) using a stopwatch or a digital timer (e.g., a smartphone stopwatch application). The female partner shall be responsible for handling the timer. The timer should be started at the moment of vaginal penetration and stopped immediately upon ejaculation. These instructions will be explained to participants prior to study initiation to ensure consistency and reliability in data collection.
After each condom use, participants will fill the coital log which is part of the case report form using a Google Form format. Also, participants will complete an acceptability and satisfaction questionnaire to assess the clinical benefits, user experience, overall satisfaction and willingness to continue or recommend the product. After completing each set of five condoms, participants will visit the investigator. During the visit, the investigator will assess safety-related findings, and any observations will be documented and reviewed.




 
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