Functional PerformanceWONDALEAF-MENNCT03324594

A Pilot Functional Performances Study of Two Synthetic Male Condom

A study testing (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator) in people with Functional Performance and Synthetic Male Condom, run by Clinical Research Centre, Malaysia at 2 sites in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Functional Performance, Synthetic Male Condom
What is being tested?: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 2 sitesMalaysia
Study dates: 1 Nov 2017to 31 Mar 2018
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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Their female sexual partners are not at risk of pregnancy (using alternate contraception);
They don't have known sexually transmitted infections, including HIV/AIDS;
They should be experienced condom users, minimum 10 male condoms used in the last 12 months;
They are between 18 to 45 years of age;
They are in a monogamous heterosexual relationship and agree to practice vaginal sex only using male condoms provided by the study.

Who cannot join

couples who work for the research team or who are close relatives of the research team;
men with known allergy to natural rubber latex;
men with known sensitivity to the residual chemicals used in the manufacture of natural rubber latex condoms or the test condom materials;
couples where one knowingly has a sexually transmitted infection.
couples who are pregnant in time of recruitment

Trial locations and contacts

2 sites in 1 country.

Malaysia2 sites

Sarawak Family Planning Association
Kuching, Sarawak, 93400
Sarawak Research Society
Kuching, Sarawak, 94200

Other trials in Malaysia

About this study

Official title: A Pilot Functional Performances Study of The Wondaleaf-Cap and The Wondaleaf-On-Man Synthetic Male Condom

Over the decades, male condoms had been widely commercialized and used to protect against unintended pregnancy and sexually transmitted infections (STI). While natural rubber latex (NRL) male condoms has majority proportion of male condoms in the market, synthetic male condoms (SMC) made from polyurethane or other synthetic materials remain new to the consumers. Notably, synthetic male condoms are found to be more durable, non-allergenic and have better compatibility with lubricants when compared to NRL male condoms. The SMCs that have FDA approval and commercially available are AvantiTM (polyisoprene condom), Trojan SupraTM (polyurethane condom) and eZ.onTM (polyurethane condom). Although the effectiveness of SMCs in the prevention of sexually transmitted infections has yet to be established, SMCs are believed to be comparable to NRL male condoms in both STI prevention and contraception protection. Notwithstanding, a recent literature had reported the shortfall on the quality of variant male condoms in the market, especially nonconforming volumetric capacity, burst pressure and freedom from holes. This warrant the current investigation, to evaluate the functional performances of two newly invented synthetic male condoms, branded as "WONDALEAF-CAP" (WLC) and "WONDALEAF-ON-MAN" (WLM). Apart from being made of polyurethane, the major feature of WLC and WLM are nonetheless their adhesive coating on the outer rim of the condom opening which by securely adhering to the foreskin, prevent slippage of condom and spillage of male ejaculate or secretions when the penis is flaccid, and thereby improve the user-friendliness of condom usage.

Conditions: Functional Performance, Synthetic Male Condom
Being tested: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)
Keywords: functional performance, synthetic male condom

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

(1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)Device
1. WONDALEAF-ON-MEN (WLM) is a polyurethane pouch with outstretching adhesive shield. The pouch covers the penis in man user; while the adhesive shield covers the groin regions to provide extra protection for the couples. The pouch is equivalent to marketed polyurethane male; while the adhesive shield is equivalent to marketed polyurethane wound dressing. WLM integrally joined with an adhesive wound dressing, both made of the same polyurethane material.
2. WONDALEAF-CAP (WLC) is a miniature form of WLM: the pouch covers glans penis and the adhesive shield wraps around the shaft of the penis only, thereby emulating the configuration of a donned regular condom on the penis. Because of the adhesive coating, WLC overcomes the problems of slippage when the penis is flaccid.
3. The durex-TOGETHER serves as the active comparator in this study. It is a transparent natural rubber latex male condom which is commercially available.

Study groups in NCT03324594
Study group	Role	What they receive
Group A	Active comparator	Participants will be first given (1) WONDALEAF-CAP, followed by (2) WONDALEAF-ON-MEN, and last with (3) durex-TOGETHER after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type. Receives: Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)
Group B	Active comparator	Participants will be first given (1) WONDALEAF-CAP, followed by (2) durex-TOGETHER, and last with (3) WONDALEAF-ON-MEN after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type. Receives: Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)
Group C	Active comparator	Participants will be first given (1) WONDALEAF-ON-MEN, followed by (2) durex-TOGETHER, and last with (3) WONDALEAF-CAP after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type. Receives: Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)
Group D	Active comparator	Participants will be first given (1) WONDALEAF-ON-MEN, followed by (2) WONDALEAF-CAP, and last with (3) durex-TOGETHER after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type. Receives: Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)
Group E	Active comparator	Participants will be first given (1) durex-TOGETHER, followed by (2) WONDALEAF-ON-MEN, and last with (3) WONDALEAF-CAP after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type. Receives: Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)
Group F	Active comparator	Participants will be first given (1) durex-TOGETHER, followed by (2) WONDALEAF-CAP, and last with (3) WONDALEAF-ON-MEN after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type. Receives: Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Slippage Rates (CSR)
Number of condoms that slipped completely off the penis during intercourse or withdrawal, divided by the number of condoms used during intercourse; reported as a percentage.
Measured: Through study completion, an average of 3 months. In specific, CSR will be evaluated within 24 hours after use of individual condom, for each condom type
Clinical Breakage Rates (CBR)
Number of condoms that broke during intercourse or withdrawal, divided by the number of condoms used during intercourse; reported as a percentage.
Measured: Through study completion, an average of 3 months. In specific, CBR will be evaluated within 24 hours after use of individual condom, for each condom type
Clinical Failure Rates (CFR)
CFR is the sum of CSR and CBR for each condom type
Measured: Through study completion, an average of 3 months. In specific, CFR will be calculated after completion of four times usage, for each condom type

Secondary outcomes (5)

Incidence of Treatment-Emergent Adverse Events
This outcome will reflect the safety of the male condoms used. Proportion of participants with symptoms of and proportion of condom uses with reports of individual complaints (eg. irritation, burning, itching, bleeding, etc.) during or immediately after any of the 3 separate uses will be calculated for each condom type. Adverse events will be classified by relatedness, expectedness and severity.
Measured: Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type
Comfort in use
This will reflect the acceptability of the male condoms used. It is a self-reported comfortability on each type of male condoms used
Measured: Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type
Ease of insertion and removal
This will reflect the acceptability of the male condoms used. It is a self-reported ease of insertion and removal for each type of male condoms used
Measured: Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type
Favorability of product attributes
This will reflect the acceptability of the male condoms used. It is a self-reported favorability towards attributes of each male condoms' type used
Measured: Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type
Adequacy and feel of lubrication
This will reflect the acceptability of the male condoms used. It is a self-reported adequacy and feel of lubrication for each type of male condoms used.
Measured: Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201731 Mar 2018

First posted27 Oct 2017
Study start1 Nov 2017
Primary completion31 Mar 2018
Study completion31 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)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: Device feasibility
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03324594
Sponsor's protocol ID: NMRR-17-1895-37590
Acronym: WONDALEAF-MEN
Status last verified: Jul 2018
First submitted: 24 Sep 2017
Last updated: 18 Jul 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bounds W, Molloy S, Guillebaud J. Pilot study of short-term acceptability and breakage and slippage rates for the loose-fitting polyurethane male condom eZ.on bi-directional: a randomized cross-over trial. Eur J Contracept Reprod Health Care. 2002 Jun;7(2):71-8.
PubMed 12201325
Duarte JT, de Almeida AE, de Mello Pereira Abrantes S. Quality evaluation of commercially available male condoms in Rio de Janeiro, Brazil, 2009-2011. Reprod Health. 2016 Dec 7;13(1):145. doi: 10.1186/s12978-016-0254-5.
PubMed 27923380
Fontanet AL, Saba J, Chandelying V, Sakondhavat C, Bhiraleus P, Rugpao S, Chongsomchai C, Kiriwat O, Tovanabutra S, Dally L, Lange JM, Rojanapithayakorn W. Protection against sexually transmitted diseases by granting sex workers in Thailand the choice of using the male or female condom: results from a randomized controlled trial. AIDS. 1998 Oct 1;12(14):1851-9. doi: 10.1097/00002030-199814000-00017.
PubMed 9792386
French PP, Latka M, Gollub EL, Rogers C, Hoover DR, Stein ZA. Use-effectiveness of the female versus male condom in preventing sexually transmitted disease in women. Sex Transm Dis. 2003 May;30(5):433-9. doi: 10.1097/00007435-200305000-00010.
PubMed 12916135
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.
PubMed 16437459
Ting CY, Ting RS, Lim CJ, King TL, Ting H, Gerofi J. Pilot study on functional performance and acceptability of two new synthetic adhesive male condoms (Wondaleaf): a randomized cross-over trial. Contraception. 2019 Jul;100(1):65-71. doi: 10.1016/j.contraception.2019.02.013. Epub 2019 Mar 11.
PubMed 30871936

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Functional Performances Study of The Wondaleaf-Cap and The Wondaleaf-On-Man Synthetic Male Condom
ClinicalTrials.gov ID: NCT03324594
Acronym / sponsor ID: WONDALEAF-MEN / NMRR-17-1895-37590
Conditions: Functional Performance, Synthetic Male Condom
Keywords: functional performance, synthetic male condom
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Clinical Research Centre, MalaysiaUniversity, hospital or other
Collaborators: Twin Catalyst Sdn Bhd, Sarawak Research Society
Study start: 1 Nov 2017 (actual)
Primary completion: 31 Mar 2018 (actual)
Study completion: 31 Mar 2018 (actual)
First posted: 27 Oct 2017 (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.

Study design

Primary purpose: Device feasibility
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Group A	Active comparator	Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)Participants will be first given (1) WONDALEAF-CAP, followed by (2) WONDALEAF-ON-MEN, and last with (3) durex-TOGETHER after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type.
Group B	Active comparator	Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)Participants will be first given (1) WONDALEAF-CAP, followed by (2) durex-TOGETHER, and last with (3) WONDALEAF-ON-MEN after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type.
Group C	Active comparator	Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)Participants will be first given (1) WONDALEAF-ON-MEN, followed by (2) durex-TOGETHER, and last with (3) WONDALEAF-CAP after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type.
Group D	Active comparator	Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)Participants will be first given (1) WONDALEAF-ON-MEN, followed by (2) WONDALEAF-CAP, and last with (3) durex-TOGETHER after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type.
Group E	Active comparator	Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)Participants will be first given (1) durex-TOGETHER, followed by (2) WONDALEAF-ON-MEN, and last with (3) WONDALEAF-CAP after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type.
Group F	Active comparator	Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)Participants will be first given (1) durex-TOGETHER, followed by (2) WONDALEAF-CAP, and last with (3) WONDALEAF-ON-MEN after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Their female sexual partners are not at risk of pregnancy (using alternate contraception);
They don't have known sexually transmitted infections, including HIV/AIDS;
They should be experienced condom users, minimum 10 male condoms used in the last 12 months;
They are between 18 to 45 years of age;
They are in a monogamous heterosexual relationship and agree to practice vaginal sex only using male condoms provided by the study.

Key exclusion criteria (5 listed)

couples who work for the research team or who are close relatives of the research team;
men with known allergy to natural rubber latex;
men with known sensitivity to the residual chemicals used in the manufacture of natural rubber latex condoms or the test condom materials;
couples where one knowingly has a sexually transmitted infection.
couples who are pregnant in time of recruitment

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
(1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)1. WONDALEAF-ON-MEN (WLM) is a polyurethane pouch with outstretching adhesive shield. The pouch covers the penis in man user; while the adhesive shield covers the groin regions to provide extra protection for the couples. The pouch is equivalent to marketed polyurethane male; while the adhesive shield is equivalent to marketed polyurethane wound dressing. WLM integrally joined with an adhesive wound dressing, both made of the same polyurethane material. 2. WONDALEAF-CAP (WLC) is a miniature form of WLM: the pouch covers glans penis and the adhesive shield wraps around the shaft of the penis only, thereby emulating the configuration of a donned regular condom on the penis. Because of the adhesive coating, WLC overcomes the problems of slippage when the penis is flaccid. 3. The durex-TOGETHER serves as the active comparator in this study. It is a transparent natural rubber latex male condom which is commercially available.	Device	Group A, Group B, Group C, Group D, Group E, Group F

Primary outcome

Clinical Slippage Rates (CSR)
Time frame: Through study completion, an average of 3 months. In specific, CSR will be evaluated within 24 hours after use of individual condom, for each condom type
Number of condoms that slipped completely off the penis during intercourse or withdrawal, divided by the number of condoms used during intercourse; reported as a percentage.
Clinical Breakage Rates (CBR)
Time frame: Through study completion, an average of 3 months. In specific, CBR will be evaluated within 24 hours after use of individual condom, for each condom type
Number of condoms that broke during intercourse or withdrawal, divided by the number of condoms used during intercourse; reported as a percentage.
Clinical Failure Rates (CFR)
Time frame: Through study completion, an average of 3 months. In specific, CFR will be calculated after completion of four times usage, for each condom type
CFR is the sum of CSR and CBR for each condom type

5 secondary outcomes

Incidence of Treatment-Emergent Adverse Events
Time frame: Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type
Comfort in use
Time frame: Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type
Ease of insertion and removal
Time frame: Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type
Favorability of product attributes
Time frame: Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type
Adequacy and feel of lubrication
Time frame: Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type

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 18 Jul 2018.
Background: PubMed 12201325Bounds W, Molloy S, Guillebaud J. Pilot study of short-term acceptability and breakage and slippage rates for the loose-fitting polyurethane male condom eZ.on bi-directional: a randomized cross-over trial. Eur J Contracept Reprod Health Care. 2002 Jun;7(2):71-8.
Background: PubMed 27923380Duarte JT, de Almeida AE, de Mello Pereira Abrantes S. Quality evaluation of commercially available male condoms in Rio de Janeiro, Brazil, 2009-2011. Reprod Health. 2016 Dec 7;13(1):145. doi: 10.1186/s12978-016-0254-5.
Background: PubMed 9792386Fontanet AL, Saba J, Chandelying V, Sakondhavat C, Bhiraleus P, Rugpao S, Chongsomchai C, Kiriwat O, Tovanabutra S, Dally L, Lange JM, Rojanapithayakorn W. Protection against sexually transmitted diseases by granting sex workers in Thailand the choice of using the male or female condom: results from a randomized controlled trial. AIDS. 1998 Oct 1;12(14):1851-9. doi: 10.1097/00002030-199814000-00017.
Background: PubMed 12916135French PP, Latka M, Gollub EL, Rogers C, Hoover DR, Stein ZA. Use-effectiveness of the female versus male condom in preventing sexually transmitted disease in women. Sex Transm Dis. 2003 May;30(5):433-9. doi: 10.1097/00007435-200305000-00010.
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.
Derived from this study: PubMed 30871936Ting CY, Ting RS, Lim CJ, King TL, Ting H, Gerofi J. Pilot study on functional performance and acceptability of two new synthetic adhesive male condoms (Wondaleaf): a randomized cross-over trial. Contraception. 2019 Jul;100(1):65-71. doi: 10.1016/j.contraception.2019.02.013. Epub 2019 Mar 11.
ISO/WD 29943-1. Condoms - Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self-reportsLink provided by the sponsor.
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.

Chuo Yew Ting, BPharm., MPhil. principal investigator

(1) Sarawak Research Society, (2) Sarawak State Health Department, Ministry of Health

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 5 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 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Malaysia. 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 Slippage Rates (CSR) (time frame: Through study completion, an average of 3 months. In specific, CSR will be evaluated within 24 hours after use of individual condom, for each condom type). The study lists 3 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 NCT03324594, which also lists 6 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 18 Jul 2018.