Functional PerformanceNCT04881877
Functional Performance and Acceptability Study of Synthetic Nitrile, and Latex Graphene, Compared to Standard Latex Male Condom
A study testing Synthetic nitrite Condom, Latex and graphene Condom and Standard latex condom in people with Functional Performance, run by Prof Mags Beksinska at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Performance
- What is being tested?
- Synthetic nitrite Condom, Latex and graphene Condom and Standard latex condom
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteSouth Africa
- Study dates
- 11 May 2021to 18 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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);
Show all 22Show fewer
- 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,
- Willing to participate in the study for the duration of 15 condom uses (approximately 3- 5 months.
- Willing to have fingerprint scan to check for co-enrolment in other research projects Female partner only: -
- Using hormonal or other non-barrier contraception (e.g. Oral Contraceptives (OC), injectable, implant, Intra Uterine Device (IUD), or have had a tubal sterilization);
- Must not be pregnant (as determined by pregnancy testing)
- Not be menopausal (defined as 12 months without menstruation);
- Not have had a hysterectomy; Male partner only: -
- Not have known erectile or ejaculatory dysfunction.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
MatCH Research Unit [Maternal, Adolescent and Child Health Research Unit]
Durban, KwaZulu-Natal, 4001
About this study
Official title: A Functional Performance and Acceptability Study of a Synthetic Nitrile Male Condom, and a Latex Graphene Male Condom Compared to a Standard Latex Male Condom
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.
Read the detailed description
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.
Purpose: The aim of the study is to evaluate the functional performance of two new male condoms compared to a control latex male condom.
Study design: The study is a randomized three-period cross-over trial of two new male condoms and a control latex male condom. The study will enrol 240 couples, anticipating that at least 200 couples will complete the study. Each couple 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. Couples will complete a Condom Log at their homes which gathers data on experience after use of each condom.
Primary Objective: To ascertain the functional performance of a latex graphene and a synthetic nitrile compared to a control latex male condom. Primary endpoints will be total clinical failure and total condom failure.
Secondary Objectives: Acceptability and safety data (as determined by the number of adverse events) occurring with each male condom type.
Population: The target population will be 240 urban, sexually-active couples who are experienced users of male condoms. Recruitment will be from the Commercial City MatCH Research Unit (MRU) site and other workplace sites in the eThekwini District.
Men and women will be told about the study. If a man/woman expresses interest in participating, they will be given the study information sheet to read, which will describe the study requirements and their potential role/partners potential in the study. If they agree to take part in the research, they will be asked to give the information sheet to their partner. If both partners in the couple are willing to participate, they will be invited to visit the enrolment site or the MRU Commercial City site and asked to provide written informed consent. Both partners will be screened to ensure they meet the requirements for study participation.
A physical examination will be undertaken to exclude visible symptoms of sexually transmitted infections. If symptoms are observed the participant will be referred to a Department of Health clinic or their doctor for treatment. A urine pregnancy test will be conducted at screening to exclude pregnancy. Both partners in the couple will need to provide the study with a copy of HIV results which are not older than 2 months. If HIV testing results are not available, voluntary HIV counselling and testing will be offered and conducted by study staff.
The consent process and all checklists, condom use logs and surveys used in the research will be written and conducted in a language that is understandable to the participant, and all relevant documents will be translated into isiZulu. Enrolled participants will be asked to use five latex graphene, five synthetic nitrile and five latex male condoms. They will be asked to return for follow-up after using five of each type of device.
At enrolment, baseline data will be gathered on participant demographics and past male condom use via the baseline questionnaire using a dildo model, the study staff will demonstrate male condom fitting and train the participants in the proper use of their first assigned male condom. Further, they will re-emphasize the instructions on how to complete the condom use log. Couples will be given one condom log to complete together. Couples will be told that they do not have to use the study male condoms during consecutive acts of intercourse. They will also be counselled on Pre Exposure Prophylaxis (PrEP) and referred to a local facility that provides PrEP should they wish to initiate PrEP. The study staff will discuss with the couple an approximate timeframe for use of all five condoms and a suitable follow-up date will be scheduled. This date will be noted on an appointment slip. Couples will be encouraged to come back if their condoms are finished before the due date and will be given the research study contact details to call for any appointment changes.
During the first follow-up visit, couples will be interviewed about their first assigned condom type and they will receive their next condom packet within their second assigned (randomized) use sequence. In the second follow-up visit, couples will be interviewed about their second assigned condom type and they will receive their next condom packet within their third assigned (randomized) use sequence.
In the third follow-up visit, couples will be interviewed about their third assigned condom type and will be discontinued from study participation. Data on device function, safety and acceptability for each condom type will be collected during follow-up visits.
- Conditions
- Functional Performance
- Being tested
- Synthetic nitrite Condom, Latex and graphene Condom, Standard latex condom
- Keywords
- synthetic nitrile male condom, latex graphene male condom, latex male condom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synthetic nitrite CondomDevice
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 CondomDevice
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.
Standard latex condomDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Device: Synthetic nitrite Condom; Device: Latex and graphene Condom; Device: Standard latex condom |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3-5 months
Secondary outcomes (2)
Safety assessed by genitourinary adverse events
Proportion of participants with symptoms of and proportion of male condom uses with reports of genitourinary irritation during or immediately after any of the five separate uses will be calculated. Medical and serious adverse events will be classified by relatedness, expectedness and severity
Measured: 3-5 months
Acceptability assessed by the frequency of key acceptability endpoints
Frequency of key acceptability endpoints will be calculated and include: comfort in use; ease of insertion and removal; like or dislike of product attributes; adequacy and feel of lubrication and sensitivity and stimulation
Measured: 3-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start11 May 2021
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Functional PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof Mags Beksinska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof Mags Beksinska, University of Witwatersrand, South Africa
- Investigators
- Mags Beksinska, PhD, Study director, MatCH Research Unit [Maternal, Adolescent and Child Health Research Unit]
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881877
- Sponsor's protocol ID
- Karex
- Status last verified
- Mar 2022
- First submitted
- 5 May 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25335833Martinez 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.
PubMed 22256688World 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.
UNFPA, Universal access to Reproductive Health: Progress and Challenges. https://www.unfpa.org/sites/default/files/pubpdf/UNFPA_Reproductive_Paper_20160120_online.pdf
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.
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
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.
PubMed 32007451Pumphrey 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.
PubMed 7994899Bousquet 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.
PubMed 16890771Walsh 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.
PubMed 12729137Gallo 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.
PubMed 16437459George 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.
PubMed 28775386ISO 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
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Functional Performance and Acceptability Study of a Synthetic Nitrile Male Condom, and a Latex Graphene Male Condom Compared to a Standard Latex Male Condom
- ClinicalTrials.gov ID
- NCT04881877
- Acronym / sponsor ID
- Karex
- Conditions
- Functional Performance
- Keywords
- synthetic nitrile male condom, latex graphene male condom, latex male condom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Prof Mags BeksinskaUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Purpose: The aim of the study is to evaluate the functional performance of two new male condoms compared to a control latex male condom.
Study design: The study is a randomized three-period cross-over trial of two new male condoms and a control latex male condom. The study will enrol 240 couples, anticipating that at least 200 couples will complete the study. Each couple 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. Couples will complete a Condom Log at their homes which gathers data on experience after use of each condom.
Primary Objective: To ascertain the functional performance of a latex graphene and a synthetic nitrile compared to a control latex male condom. Primary endpoints will be total clinical failure and total condom failure.
Secondary Objectives: Acceptability and safety data (as determined by the number of adverse events) occurring with each male condom type.
Population: The target population will be 240 urban, sexually-active couples who are experienced users of male condoms. Recruitment will be from the Commercial City MatCH Research Unit (MRU) site and other workplace sites in the eThekwini District.
Men and women will be told about the study. If a man/woman expresses interest in participating, they will be given the study information sheet to read, which will describe the study requirements and their potential role/partners potential in the study. If they agree to take part in the research, they will be asked to give the information sheet to their partner. If both partners in the couple are willing to participate, they will be invited to visit the enrolment site or the MRU Commercial City site and asked to provide written informed consent. Both partners will be screened to ensure they meet the requirements for study participation.
A physical examination will be undertaken to exclude visible symptoms of sexually transmitted infections. If symptoms are observed the participant will be referred to a Department of Health clinic or their doctor for treatment. A urine pregnancy test will be conducted at screening to exclude pregnancy. Both partners in the couple will need to provide the study with a copy of HIV results which are not older than 2 months. If HIV testing results are not available, voluntary HIV counselling and testing will be offered and conducted by study staff.
The consent process and all checklists, condom use logs and surveys used in the research will be written and conducted in a language that is understandable to the participant, and all relevant documents will be translated into isiZulu. Enrolled participants will be asked to use five latex graphene, five synthetic nitrile and five latex male condoms. They will be asked to return for follow-up after using five of each type of device.
At enrolment, baseline data will be gathered on participant demographics and past male condom use via the baseline questionnaire using a dildo model, the study staff will demonstrate male condom fitting and train the participants in the proper use of their first assigned male condom. Further, they will re-emphasize the instructions on how to complete the condom use log. Couples will be given one condom log to complete together. Couples will be told that they do not have to use the study male condoms during consecutive acts of intercourse. They will also be counselled on Pre Exposure Prophylaxis (PrEP) and referred to a local facility that provides PrEP should they wish to initiate PrEP. The study staff will discuss with the couple an approximate timeframe for use of all five condoms and a suitable follow-up date will be scheduled. This date will be noted on an appointment slip. Couples will be encouraged to come back if their condoms are finished before the due date and will be given the research study contact details to call for any appointment changes.
During the first follow-up visit, couples will be interviewed about their first assigned condom type and they will receive their next condom packet within their second assigned (randomized) use sequence. In the second follow-up visit, couples will be interviewed about their second assigned condom type and they will receive their next condom packet within their third assigned (randomized) use sequence.
In the third follow-up visit, couples will be interviewed about their third assigned condom type and will be discontinued from study participation. Data on device function, safety and acceptability for each condom type will be collected during follow-up visits.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Synthetic nitrite Condom | Experimental | Device: Synthetic nitrite Condom, Device: Latex and graphene Condom, Device: Standard latex condomParticipants 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 |
| Latex and graphene Condom | Experimental | Device: Synthetic nitrite Condom, Device: Latex and graphene Condom, Device: Standard latex condomParticipants 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. |
| Standard latex condom: | Experimental | Device: Synthetic nitrite Condom, Device: Latex and graphene Condom, Device: Standard latex condomParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- 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);
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synthetic nitrite CondomThe 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, Standard latex condom:, Synthetic nitrite Condom |
| Latex and graphene CondomThe 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 | Latex and graphene Condom, Standard latex condom:, Synthetic nitrite Condom |
| Standard latex condomThe 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 | Device | Latex and graphene Condom, Standard latex condom:, Synthetic nitrite Condom |
Primary outcome
Clinical breakage
Time frame: 3-5 months
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.
Non-Clinical breakage
Time frame: 3-5 months
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
Total breakage
Time frame: 3-5 months
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.
Slippage
Time frame: 3-5 months
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.
Total clinical failure
Time frame: 3-5 months
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.
Total male condom failure
Time frame: 3-5 months
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
2 secondary outcomes
Safety assessed by genitourinary adverse events
Time frame: 3-5 months
Acceptability assessed by the frequency of key acceptability endpoints
Time frame: 3-5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Background: PubMed 25335833Warren 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.
- Background: PubMed 22256688Martinez 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.
- BackgroundWorld 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.
- BackgroundUNFPA, Universal access to Reproductive Health: Progress and Challenges. https://www.unfpa.org/sites/default/files/pubpdf/UNFPA_Reproductive_Paper_20160120_online.pdf
- BackgroundShisana 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.
- BackgroundMuchiri 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: PubMed 32007451Beksinska 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.
- Background: PubMed 7994899Pumphrey 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.
- Background: PubMed 16890771Bousquet 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.
- Background: PubMed 12729137Walsh 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.
- Background: PubMed 16437459Gallo 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.
- Background: PubMed 28775386George 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mags Beksinska, PhD study director
MatCH Research Unit [Maternal, Adolescent and Child Health Research Unit]
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synthetic nitrite Condom, Latex and graphene Condom and Standard latex condom in people with Functional Performance, run by Prof Mags Beksinska at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical breakage (time frame: 3-5 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04881877, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.