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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 - 5 months

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

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include elderly individuals above the age of eighty-five?

"Participants in this trial must be of age and under 45 years old."

Answered by AI

Is it possible for me to qualify and join this experimental investigation?

"Those eligible for this study must be afflicted with a sexually transmitted infection and aged between 18-45. The trial has been approved to recruit 600 individuals in total."

Answered by AI

How extensive is the participant pool of this experiment?

"Affirmative, clinicaltrials.gov has the most recent information on this medical study. It was first published on October 1st 2023 and last updated 9 days later. To complete the trial 600 patients must be recruited from 3 distinct research sites."

Answered by AI

Is enrollment in this trial currently available to qualifying participants?

"Affirmative. According to clinicaltrials.gov, this medical trial commenced on October 1st 2023 and it is currently seeking 600 volunteers from 3 different sites for recruitment purposes."

Answered by AI

What are the key aims of this research initiative?

"The primary result of the study, which will be tracked over a period lasting 3 to 5 months, is Clinical Slippage. As secondary outcomes, Acceptability (including comfort in use, fitting and removal ease as well as product attribute preferences,) Non-Clinical Breakage (breakages that don't have any adverse clinical consequences) and Non-Clinical Slip page(slippages along the shaft of the penis during sexual intercourse without completely falling off ) should all be evaluated through Likert scores ranging from 1 to 5 compared across condom types."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Synthetic Nitrile Male Condom Compared to Standard Latex Male Condom

2023. "Evaluation of Synthetic Nitrile Male Condom Compared to Standard Latex Male Condom". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06079060.