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

NCT04881877 | Completed

• 1 other identifier: Karex
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

synthetic nitrile male condom; latex graphene male condom; latex male condom

Outcome Measures

Primary Outcomes (6)

• Clinical breakage

  Clinical breakage is defined as breakage during sexual intercourse or during withdrawal of the male condom from the vagina. Clinical breakage is breakage with potential adverse clinical consequences. The clinical breakage rate is calculated by dividing the number of male condoms reported to have broken during sexual intercourse or during withdrawal by the number of male condoms used during sexual intercourse.

  3-5 months

• Non-Clinical breakage

  Defined as breakage noticed before sexual intercourse or occurring after withdrawal of the male condom from the vagina. Non-clinical breakage is breakage with no potential adverse clinical consequences. The non-clinical breakage rate is calculated by dividing the number of male condoms reported to have broken before sexual intercourse or after withdrawal by the number of male condom packages opened

  3-5 months

• Total breakage

  Total breakage is defined as the sum of all male condom breakages at any time before, during or after sexual intercourse. It includes both clinical breakages and non-clinical breakages. The total breakage rate is calculated by dividing the total number of male condoms that broke by the number of male condom packages opened.

  3-5 months

• Slippage

  Slippage is defined as an instance when a male condom slips completely off the penis during sexual intercourse or during withdrawal from the vagina. The slippage rate is calculated by dividing the number of male condoms that slipped by the number of male condoms used during sexual intercourse.

  3-5 months

• Total clinical failure

  Total clinical failure is defined as the sum of male condoms that clinically break or slip, or any additional failure modes(s) identified in the risk assessment which results in the reduction of the male condom protective function. The total clinical failure rate is calculated by dividing the number of male condoms with a clinical failure by the number of male condoms used during sexual intercourse.

  3-5 months

• Total male condom failure

  Total male condom failure is defined as a male condom for which a non-clinical breakage, clinical breakage or slippage occurs, or is associated with any additional failure modes(s) identified in the risk assessment. The male condom failure rate is calculated by dividing the number of male condoms that fail by the number of male condom packages opened

  3-5 months

Secondary Outcomes (2)

• Safety assessed by genitourinary adverse events

  3-5 months

• Acceptability assessed by the frequency of key acceptability endpoints

  3-5 months

Study Arms (3)

Synthetic nitrite Condom

EXPERIMENTAL

Participants will be randomized to condom use order. Participants will be provided with 5 synthetic nitrite condoms at the first visit and switched to 5 of either the latex graphene condom or latex condom at visit 2 and 3. All couples will use each of the 3 condom types during the study

Device: Synthetic nitrite Condom; Device: Latex and graphene Condom; Device: Standard latex condom

Latex and graphene Condom

EXPERIMENTAL

Participants will be randomized to condom use order. Participants will be provided with 5 latex graphene condoms at the first visit and switched to 5 of either the synthetic nitrite condom or latex condom at visit 2 and 3. All couples will use each of the 3 condom types during the study.

Device: Synthetic nitrite Condom; Device: Latex and graphene Condom; Device: Standard latex condom

Standard latex condom:

EXPERIMENTAL

Participants will be randomized to condom use order. Participants will be provided with 5 latex condom at the first visit and switched to 5 of either the latex graphene condom or synthetic nitrite condoms at visit 2 and 3. All couples will use each of the 3 condom types during the study.

Device: Synthetic nitrite Condom; Device: Latex and graphene Condom; Device: Standard latex condom

Interventions

Synthetic nitrite Condom DEVICE

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.

Latex and graphene Condom; Standard latex condom:; Synthetic nitrite Condom

Latex and graphene Condom DEVICE

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.

Latex and graphene Condom; Standard latex condom:; Synthetic nitrite Condom

Standard latex condom DEVICE

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

Latex and graphene Condom; Standard latex condom:; Synthetic nitrite Condom

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All couples enrolled in this research must meet the following selection criteria:
• Be between the ages of 18 and 45 years (inclusive);
• Be literate (able to read a newspaper or letter easily);
• Have been in an exclusive (monogamous) sexual relationship with partner for at least 6 months; and intend to continue to be an exclusive (monogamous) sexual relationship with partner with their spouse or partner while participating in this research study;
• Not planning a pregnancy during the time of the research study;
• Be sexually active (defined as having at least two vaginal coital acts per week and not being abstinent in the month prior to enrolment);
• Not have any genital piercings, use genital beading or any other drugs or non-study devices that can affect sexual performance;
• Not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms;
• Be without observable evidence of Sexually transmitted infections (STI) as determined through syndromic diagnosis and vaginal/penile examination;
• Not be HIV positive
• Willing to give informed consent;
• Willing to complete the male condom coital use logs;
• Willing to use the study condoms as directed;
• Willing to adhere to the follow-up schedule and all study procedures;
• Willing to provide research study staff with an address, phone number or other locator information while participating in the study; and,

Sponsors & Collaborators

• Prof Mags Beksinska: lead

Study Sites (1)

MatCH Research Unit [Maternal, Adolescent and Child Health Research Unit]

Durban, KwaZulu-Natal, 4001, South Africa

Location

Related Publications (14)

• Warren M. Condoms: the multipurpose prevention technologies that already exist. BJOG. 2014 Oct;121(Suppl 5):9-11. doi: 10.1111/1471-0528.12913. No abstract available.

  PMID: 25335833 BACKGROUND

• Martinez G, Copen CE, Abma JC. Teenagers in the United States: sexual activity, contraceptive use, and childbearing, 2006-2010 national survey of family growth. Vital Health Stat 23. 2011 Oct;(31):1-35.

  PMID: 22256688 BACKGROUND

• World Health Organization Department of Reproductive Health and Research (WHO/RHR), John Hopkins Bloomberg School of Public Health/Center for Communication Programs (CCP). Family Planning: A Global Handbook for Providers (2018 update) [Internet]. Baltimore and Geneva: CCP and WHO; 2018 [CITED 2019 June 20]. 442p. Available from http://apps.who.int/iris/bitstream/10665/260156/1/9780999203705- eng.pdf?ua=1.

  BACKGROUND

• UNFPA, Universal access to Reproductive Health: Progress and Challenges. https://www.unfpa.org/sites/default/files/pubpdf/UNFPA_Reproductive_Paper_20160120_online.pdf

  BACKGROUND

• Shisana O, Rehle T, Simbayi LC, et al. South African national HIV prevalence, incidence, behaviour and communication survey 2017: Health and wellbeing: Human Science Research Council Press; 2017.

  BACKGROUND

• Muchiri E, Odimegwu E, DeWet N. HIV risk perception and consistency in condom use among adolescents and young adults in urban Cape Town, South Africa: a cumulative risk analysis. S Afr J Infect Dis [Internet]. 2017 [cited 2019 Sep 8]; 32(3):105-110. Available from: https://doi.org/10.1080/23120053.2017.1332800

  BACKGROUND

• Beksinska M, Wong R, Smit J. Male and female condoms: Their key role in pregnancy and STI/HIV prevention. Best Pract Res Clin Obstet Gynaecol. 2020 Jul;66:55-67. doi: 10.1016/j.bpobgyn.2019.12.001. Epub 2019 Dec 14.

  PMID: 32007451 BACKGROUND

• Pumphrey RS. Allergy to Hevea latex. Clin Exp Immunol. 1994 Dec;98(3):358-60. doi: 10.1111/j.1365-2249.1994.tb05497.x. No abstract available.

  PMID: 7994899 BACKGROUND

• Bousquet J, Flahault A, Vandenplas O, Ameille J, Duron JJ, Pecquet C, Chevrie K, Annesi-Maesano I. Natural rubber latex allergy among health care workers: a systematic review of the evidence. J Allergy Clin Immunol. 2006 Aug;118(2):447-54. doi: 10.1016/j.jaci.2006.03.048. Epub 2006 Jul 3.

  PMID: 16890771 BACKGROUND

• Walsh TL, Frezieres RG, Peacock K, Nelson AL, Clark VA, Bernstein L. Evaluation of the efficacy of a nonlatex condom: results from a randomized, controlled clinical trial. Perspect Sex Reprod Health. 2003 Mar-Apr;35(2):79-86.

  PMID: 12729137 BACKGROUND

• Gallo MF, Grimes DA, Lopez LM, Schulz KF. Non-latex versus latex male condoms for contraception. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD003550. doi: 10.1002/14651858.CD003550.pub2.

  PMID: 16437459 BACKGROUND

• George G, Sisupal SB, Tomy T, Pottammal BA, Kumaran A, Suvekbala V, Gopimohan R, Sivaram S, Ragupathy L. Thermally conductive thin films derived from defect free graphene-natural rubber latex nanocomposite: Preparation and properties. Carbon N Y. 2017 Aug;119:527-534. doi: 10.1016/j.carbon.2017.04.068.

  PMID: 28775386 BACKGROUND

• ISO 29943-1:2017 Condoms - Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self-reports. https://www.iso.org/standard/62497.html

  BACKGROUND

• Steiner M, Piedrahita C, Joanis C, Glover L, Spruyt A. Condom Breakage and Slippage Rates Among Study Participants in Eight Countries. Int Fam Plan perspect 1994 ;20:55-58

  BACKGROUND

Study Officials

• Mags Beksinska, PhD

  MatCH Research Unit [Maternal, Adolescent and Child Health Research Unit]

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Analysts will be blinded until all data have been captured and the primary analysis programs have been verified. Likewise, all reasonable attempts will be made to keep other non-monitor staff blinded during the course of the study. The statistician analyzing the data will not be blinded. Due to slight differences related to colour of the study products, it will not be possible to blind participants and clinic staff associated with the project
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Executive Director

Model Details: The study is a randomized cross-over trial to evaluate the functional performance of two new male condoms compared to a control latex male condom.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 11, 2021
• Study Start: May 11, 2021
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)