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Functional Performance and Acceptability Study of Synthetic Nitrile, and Latex Graphene, Compared to Standard Latex Male Condom

NCT04881877 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2022-03-02

No results posted yet for this study

Summary

Two new male condoms have been developed - one made of synthetic nitrile and the other made of latex graphene. Both new condoms are of the same design as a standard latex male condom. The aim of this study is to evaluate the functional performance of two new male condoms compared to a control latex male condom. Couples enrolled in the study will be asked to use five latex graphene, five synthetic nitrile and five latex male condoms in a randomized type order. Function, safety, and acceptability will be assessed at three follow-up visits approximately one month apart after enrolment.

Conditions

  • Functional Performance

Interventions

DEVICE

Synthetic nitrite Condom

The condoms is composed of a synthetic nitrile rubber latex and 170 mm in length and is 53mm wide. It has a teat ended shape and bead retention mechanism at the top. It is pre-lubricated with silicone oil. It has a shelf-life of 5 years and clear and colourless. It is manufactured by Karex Industries. It is currently experimental.

DEVICE

Latex and graphene Condom

The condom is composed of a natural rubber latex with graphene. It is 170 mm in length and is 53mm wide. It has a teat ended shape and bead retention mechanism at the top. It is pre-lubricated with silicone oil. It has a shelf-life of 5 years and is greyish in colour. It is manufactured by Karex Industries. It is currently experimental.

DEVICE

Standard latex condom

The condoms is composed of a natural rubber latex. It is 180 mm in length and is 53mm wide. It has a teat ended shape and bead retention mechanism at the top. It is pre-lubricated with silicone oil. It has a shelf-life of 5 years and is natural in colour. It is manufactured by Karex Industries. It has World Health Organisation (WHO)/UNFPA, India Drug Control Authority, Conformitè Europëenne (CE) Mark of the European Union, South African Bureau of Standards and US FDA approval

Sponsors & Collaborators

  • Prof Mags Beksinska

    lead OTHER

Principal Investigators

  • Mags Beksinska, PhD · MatCH Research Unit [Maternal, Adolescent and Child Health Research Unit]

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-11
Primary Completion
2022-02-18
Completion
2022-02-18

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04881877 on ClinicalTrials.gov