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Barrier Method

Synthetic Nitrile vs Latex Condoms for STI Prevention

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 how well 3 types of male condoms protect against pregnancy.

Who is the study for?

Couples aged 18-45, in a monogamous relationship for at least 3 months, who are sexually active and agree to use only study condoms and lubricant. Excludes those with allergies to latex or nitrile, STI symptoms or HIV positive status, pregnant women or those wanting pregnancy soon, participants in other condom studies, employees of the trial's institutions, sex workers, men with sexual dysfunction and individuals with genital piercings.Check my eligibility

What is being tested?

The trial is testing two sizes of synthetic nitrile male condoms against a standard latex condom. Participants will use each type over three periods while reporting on their performance during intercourse. The study aims to assess how well these new condoms work compared to the traditional ones.See study design

What are the potential side effects?

Potential side effects may include allergic reactions if sensitivity to materials exists (though people with known allergies are excluded), discomfort during use depending on individual fit and preference for material type.

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

Genital discomfort

Non-Clinical breakage

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Synthetic Nitrile Condoms (56mm)Experimental Treatment1 Intervention

56mm width synthetic nitrile condoms

Group II: Synthetic Nitrile Condoms (53mm)Experimental Treatment1 Intervention

53mm width synthetic nitrile condoms

Group III: Control Latex CondomActive Control1 Intervention

Commercial natural rubber latex condom

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

University of Witwatersrand, South AfricaOTHER

98 Previous Clinical Trials

9,943,736 Total Patients Enrolled

Essential Access HealthOTHER

6 Previous Clinical Trials

2,270 Total Patients Enrolled

Media Library

Control Latex Condom (Barrier Method) Clinical Trial Eligibility Overview. Trial Name: NCT05912283 — N/A

Sexually Transmitted Infections Research Study Groups: Synthetic Nitrile Condoms (56mm), Control Latex Condom, Synthetic Nitrile Condoms (53mm)

Sexually Transmitted Infections Clinical Trial 2023: Control Latex Condom Highlights & Side Effects. Trial Name: NCT05912283 — N/A

Control Latex Condom (Barrier Method) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05912283 — N/A

Frequently Asked Questions

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

What is the intended purpose of this medical experiment?

"This trial will be assessing the efficacy of clinical breakage over a period ranging from 3 to 5 months. Secondary metrics such as acceptability, non-clinical breakage and non-clinical slippage are also being tracked for statistical analysis. These parameters consist of comfort in use, ease of insertion/removal, like or dislike of product attributes, lubrication adequacy and feel etc., plus quantifying any possible breakages before sexual intercourse or after withdrawal from vagina and partial slipping during sexual intercourse respectively."

Answered by AI

What is the total number of participants that have been enrolled in this research?

"Affirmative. According to clinicaltrials.gov, this medical study - first posted on June 2nd 2023 - is currently recruiting patients with 600 participants required from 3 different sites."

Answered by AI

What qualifications are required to join this medical study?

"Patients that wish to join this clinical trial must have a sexually transmitted infection and be in the age range of 18-45. In total, 600 participants are being accepted."

Answered by AI

Does this research initiative accept participants aged 55 and above?

"This research study is actively seeking volunteers aged 18 to 45."

Answered by AI

Are there any remaining vacancies for participants in this experiment?

"As reported on clinicaltrials.gov, this trial is still recruiting patients. It was first announced on June 2nd 2023 and the information has been updated as recently as June 12th of that same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom

2023. "Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05912283.