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Barrier Method

Synthetic Nitrile Condom for Preventing Sexually Transmitted Infections

N/A
Recruiting
Led By Mags Beksinska, PhD
Research Sponsored by Karex Industries Sdn. Bhd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 - 5 months
Awards & highlights

Study Summary

This trial compares two types of condoms to see which one is more effective.

Who is the study for?
This trial is for couples aged 18-45 in a monogamous relationship, sexually active, and not planning pregnancy. Men must be able to ejaculate during sex and hold the condom after intercourse. Women should use non-barrier contraception or men be vasectomized. Participants can't have STIs, genital piercings/beading, latex/nitrile allergies, sexual performance issues or work for the study's institutions.Check my eligibility
What is being tested?
The study compares synthetic nitrile condoms with standard latex condoms over ten uses each by random assignment in a cross-over design. Couples will switch between condom types halfway through the trial to assess differences in performance and safety.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to either latex or synthetic nitrile materials used in the condoms or irritation from lubricants provided with the products.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 - 5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 - 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical breakage
Clinical failure
Clinical slippage
Secondary outcome measures
Acceptability i.e Comfort in use, ease of fitting and removal, like or dislike of product attributes, adequacy and feel of lubrication.
Genital discomfort
Non-Clinical breakage
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Synthetic Nitrile Condom (61mm)Experimental Treatment1 Intervention
61mm width synthetic Nitrile condoms
Group II: Control Latex CondomActive Control1 Intervention
61mm width Natural Rubber Latex condoms

Find a Location

Who is running the clinical trial?

Karex Industries Sdn. Bhd.Lead Sponsor
1 Previous Clinical Trials
600 Total Patients Enrolled
Essential Access HealthOTHER
6 Previous Clinical Trials
2,270 Total Patients Enrolled
Sigma3 Services SARLUNKNOWN
1 Previous Clinical Trials
600 Total Patients Enrolled
~379 spots leftby May 2025
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