Health Condition 1: F524- Premature ejaculation
Conditions
Interventions
Intervention1: 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 lubr
Sponsors
Karex Industries Sdn. Bhd.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 areaTimepoint: 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
| Measure | Time frame |
|---|---|
| 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 candidiasisTimepoint: 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) | — |
Countries
India
Contacts
Public ContactDr M Gopinath
Sudha Hospitals,Erode,Tamil Nadu
Outcome results
None listed