ContraceptionNCT04622306

Evaluation of Polyurethane Male Condoms

A study of Contraception and Prevention of Sexually Transmitted Infections, run by Sagami Rubber Industries Co., Ltd. at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Contraception, Prevention of Sexually Transmitted Infections
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteUnited States
Study dates: 12 Oct 2020to 30 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Between the ages of 18 and 45 (inclusive)
Protected against pregnancy by oral contraceptives, an IUD, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
Have home internet access, a valid personal email for each partner, ability to videoconference and use electronic signature technology
Willing and able to give electronic informed consent
Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms via interview or self-administered questionnaires
Have vaginal intercourse at least once weekly

Show all 17Show fewer

Willing to use the study products for fifteen acts of vaginal intercourse within nine weeks of study entry
In a mutually exclusive monogamous relationship with their study partner for at least 6 months and be willing to remain mutually monogamous throughout study participation
Both study partners have previous experience using male condoms
Agree not to use any additional vaginal or sexual lubricant except the AstroglideTM product provided, if desired, supplied by the study
Agree not to expose the study condoms to jewelry (hand, facial, or genital) or piercings (facial or genital) that could damage the study condoms.
Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms
Male partner agrees to ejaculate during vaginal intercourse
Agree to (or partner) hold the condom at the base of the erect penis during withdrawal
Agree to return any condoms that break during use
Agree to return any unopened condoms
Reachable by telephone

Who cannot join

Currently participating in another similar clinical study
Female partner self-reported as pregnant
Allergic to natural rubber latex or polyurethane, or has a history of recurrent adverse events following use of latex or polyurethane products
Unable to follow study requirements, use instructions or attend study visits or exchanges
Have a significant (high) risk of STIs, including HIV infection, or having a medical history of recurrent, uncontrolled STIs (e.g. gonorrhoea, syphilis, Chlamydia, etc.)
Currently using condoms for protection against a known STI

Show all 11Show fewer

Taking any internally applied medication to treat a genital condition that could interact with the study condom
Male partner has used medication that has caused erectile dysfunction, or had difficulty achieving/maintaining an erection, or achieving ejaculation in the last month under typical circumstances/conditions
Male has had a prostatectomy
Any self-reported genitourinary condition (e.g. itching, burning, irritation, etc.) which, in the opinion of the investigator, could affect use of the study condoms or the ability to interpret study data
Employee or affiliate of Essential Access Health or Sagami Rubber Industries Co., Ltd.

Trial locations and contacts

1 site in 1 country.

United States1 site

Essential Access Health
Los Angeles, California, 90010-2648

Other trials in United States

About this study

Official title: A Randomized, Masked, 3-way Cross-over, Multi-center, Clinical Investigation to Evaluate Two Polyurethane Condoms in Healthy Monogamous Couples Compared With a Standard Latex Condom

The clinical study will compare two lubricated polyurethane male condoms of different thickness with a marketed lubricated control male condom made of natural rubber latex. This crossover study will randomize 300 heterosexual couples to the sequence in which they use five condoms of each of the three study condom types. The clinical failure (breakage and slippage) rates of the two polyurethane condoms will be compared to the clinical failure (breakage and slippage) rate of commercial natural rubber latex control condom using a statistical test of non-inferiority. The study will also compare the acceptability of the two polyurethane condom different thickness with that of the natural rubber latex control condom obtained from interviews and questionnaires with subject couples.

Read the detailed description

The clinical study will compare two lubricated polyurethane male condoms of different thickness and different sizes with a marketed lubricated control male condom made of natural rubber latex.

Couples entering the study will be expected to use 5 of each type of the 3 condoms in a randomised order. The identity of the condoms will be masked to both the couples and the investigators. The aim will be to recruit 300 heterosexual with the intent of achieving a minimum 1,000 uses of each condom type. Couples will report condom use events using a condom report form. The primary information collected will relate to condom breakage and slippage of the penis during use.

The total clinical failure rates (breakage and slippage) of the two polyurethane condoms will be compared to the clinical failure (breakage and slippage) rate of commercial natural rubber latex control condom using a statistical test of non-inferiority. The study will also compare the acceptability of the two polyurethane condom different thickness with that of the natural rubber latex control condom obtained from interviews and questionnaires with subject couples.

Conditions: Contraception, Prevention of Sexually Transmitted Infections
Being tested: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B

What participants receive

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

Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom BDevice
Condom functionality study to determine failure rates

Study groups in NCT04622306
Study group	Role	What they receive
Control Latex Condom C	Active comparator	Commercial Natural Rubber Latex Male Condom Receives: Device: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B
Polyurethane Condom A	Experimental	Polyurethane Condom A (002) Receives: Device: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B
Polyurethane Condom B	Experimental	Polyurethane Condom B (001) Receives: Device: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B

What is being measured

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

Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017.
To confirm each experimental condom is non-inferior to the control condom with respect to total clinical failure rate. The definition of total clinical failure rate as specified in ISO 29943-1:2017 will be used. The Total Clinical Failure Rate is Defined as the Number of Condoms with at least One Acute Failure Event (e.g. Clinical Breakage or Clinical Slippage) Divided by the Number of Condoms Used During Intercourse; Typically Reported as a Percentage; Any Condom which Experiences Multiple Clinical Failure Events Only Count as a Single Clinical Failure.
To be eligible for inclusion in the non-inferiority analysis the each couple had to have used at least one of the appropriate experimental condoms and at least one control condom. This means that the numbers of participants and condoms reported in each of the two non-inferiority comparisons will differ.
Measured: Self Completion of Questionnaires Within 12 Hours of condom use. Questionnaires returned to investigators when receiving next set of 5 condoms. All sets of questionnaires returned within 9 weeks of couple starting.

Timeline

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

12 Oct 202030 Dec 2021

First posted9 Nov 2020
Study start12 Oct 2020
Primary completion6 Dec 2021
Study completion30 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ContraceptionStudies 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: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04622306
Sponsor's protocol ID: SAGCS 2
Status last verified: Sep 2023
First submitted: 2 Nov 2020
Last updated: 6 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Potter W, Burt G, Walsh T. Clinical breakage, slippage and acceptability of two commercial ultra-thin polyurethane male condoms compared to a commercial thin latex condom: a randomised, masked, 3 way crossover, multi centre controlled study (SAGCS 2). Reprod Health. 2024 Sep 4;21(1):128. doi: 10.1186/s12978-024-01873-3.
PubMed 39232840

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?

See locations

Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms

All Contraception trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Masked, 3-way Cross-over, Multi-center, Clinical Investigation to Evaluate Two Polyurethane Condoms in Healthy Monogamous Couples Compared With a Standard Latex Condom
ClinicalTrials.gov ID: NCT04622306
Acronym / sponsor ID: SAGCS 2
Conditions: Contraception, Prevention of Sexually Transmitted Infections
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Sagami Rubber Industries Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Essential Access Health
Study start: 12 Oct 2020 (actual)
Primary completion: 6 Dec 2021 (actual)
Study completion: 30 Dec 2021 (actual)
First posted: 9 Nov 2020 (actual)
Results: Posted 28 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The clinical study will compare two lubricated polyurethane male condoms of different thickness and different sizes with a marketed lubricated control male condom made of natural rubber latex.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Control Latex Condom C	Active comparator	Device: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom BCommercial Natural Rubber Latex Male Condom
Polyurethane Condom A	Experimental	Device: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom BPolyurethane Condom A (002)
Polyurethane Condom B	Experimental	Device: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom BPolyurethane Condom B (001)

Who may qualify

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

Key inclusion criteria (17 listed)

Between the ages of 18 and 45 (inclusive)
Protected against pregnancy by oral contraceptives, an IUD, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
Have home internet access, a valid personal email for each partner, ability to videoconference and use electronic signature technology
Willing and able to give electronic informed consent
Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms via interview or self-administered questionnaires

Key exclusion criteria (11 listed)

Currently participating in another similar clinical study
Female partner self-reported as pregnant
Allergic to natural rubber latex or polyurethane, or has a history of recurrent adverse events following use of latex or polyurethane products
Unable to follow study requirements, use instructions or attend study visits or exchanges
Have a significant (high) risk of STIs, including HIV infection, or having a medical history of recurrent, uncontrolled STIs (e.g. gonorrhoea, syphilis, Chlamydia, etc.)

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
Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom BCondom functionality study to determine failure rates	Device	Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B

Primary outcome

Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017.
Time frame: Self Completion of Questionnaires Within 12 Hours of condom use. Questionnaires returned to investigators when receiving next set of 5 condoms. All sets of questionnaires returned within 9 weeks of couple starting.
To confirm each experimental condom is non-inferior to the control condom with respect to total clinical failure rate. The definition of total clinical failure rate as specified in ISO 29943-1:2017 will be used. The Total Clinical Failure Rate is Defined as the Number of Condoms with at least One Acute Failure Event (e.g. Clinical Breakage or Clinical Slippage) Divided by the Number of Condoms Used During Intercourse; Typically Reported as a Percentage; Any Condom which Experiences Multiple Clinical Failure Events Only Count as a Single Clinical Failure. To be eligible for inclusion in the non-inferiority analysis the each couple had to have used at least one of the appropriate experimental condoms and at least one control condom. This means that the numbers of participants and condoms reported in each of the two non-inferiority comparisons will differ.

Results and safety

Results posted to the registry on 28 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Couples Assigned to Sequence ABC	48	46
Couples Assigned to Sequence ACB	50	48
Couples Assigned to Sequence BAC	48	48
Couples Assigned to Sequence BCA	51	51
Couples Assigned to Sequence CAB	53	51
Couples Assigned to Sequence CBA	50	45

Primary outcome: Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017.

Time frame: Self Completion of Questionnaires Within 12 Hours of condom use. Questionnaires returned to investigators when receiving next set of 5 condoms. All sets of questionnaires returned within 9 weeks of couple starting.. Count of units. Unit: Condom uses

Measure	Polyurethane Condoms A Used in Non-inferiority Analysis Condom A of Versus Condom C n = 504	Latex Condoms C Used in Non-inferiority Analysis of Condom A Versus Condom C n = 504	Polyurethane Condoms B Used in Non-inferiority Analysis of Condom B Versus Condom C n = 494	Latex Condom C Used in Non-inferiority Analysis of Condom B Versus Condom C n = 494
Primary Analysis of Study Data: Clinical Breaks	15	10	22	9
Primary Analysis of Study Data: Clinical slippages	13	6	13	6
Primary Analysis of Study Data: Successful Uses	1165	1196	1107	1178
Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm.: Clinical Breaks	0	0	12	5
Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm.: Clinical slippages	0	0	8	6
Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm.: Successful Uses	0	0	866	904

Polyurethane Condoms A Used in Non-inferiority Analysis Condom A of Versus Condom C vs Latex Condoms C Used in Non-inferiority Analysis of Condom A Versus Condom C: Upper 97.5% CL for difference: 2.5, p = 0.025, GEE
Polyurethane Condoms B Used in Non-inferiority Analysis of Condom B Versus Condom C vs Latex Condom C Used in Non-inferiority Analysis of Condom B Versus Condom C: Upper 97.5% CLof difference: 2.5, p = 0.025, GEE
Polyurethane Condoms B Used in Non-inferiority Analysis of Condom B Versus Condom C vs Latex Condom C Used in Non-inferiority Analysis of Condom B Versus Condom C: Upper 97.5% CL for difference: 2.37, p = 0.025, GEE

Population analysed: The number of participants and condoms used for the non-inferiority assessment of Condom A versus Condom C and the equivalent numbers in the non-inferiority assessment of Condom B versus Condom C differ because some men found Condom B to be too small to use.

Adverse events

Time frame: Participants completed report forms after each condom use. Each condom report elicited information about specific adverse event usually experienced when using condoms including discomfort caused by burning, irritation and itching sensations, rashes, constriction, decreased sensitivity and dryness. Participants were expected to use all 15 condoms within 9 weeks, which can therefore be regarded as the monitoring period for adverse event.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Polyurethane Condom A	4 of 337 (1.2%)	41 of 337 (12.2%)	0 of 337
Polyurethane Condom B	10 of 392 (2.6%)	85 of 392 (21.7%)	0 of 392
Control Latex Condom C	20 of 332 (6%)	87 of 332 (26.2%)	0 of 332

Limitations and caveats (from the sponsor): All condom use events were self reported. There is a potential for misreporting the number of events. Since the trial was masked it was not feasible to preselect men with smaller penises to use the smaller Condom B. Instead, a post hoc analysis of the association between penis size and clinical failure rates was conducted followed by a further non-inferiority analysis after excluding men with penis lengths exceeding the specified nominal length of Condom B (170 mm).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39232840Potter W, Burt G, Walsh T. Clinical breakage, slippage and acceptability of two commercial ultra-thin polyurethane male condoms compared to a commercial thin latex condom: a randomised, masked, 3 way crossover, multi centre controlled study (SAGCS 2). Reprod Health. 2024 Sep 4;21(1):128. doi: 10.1186/s12978-024-01873-3.
Individual participant dataSharing planned: No

Related trials for Contraception

Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms

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.

Grant R Burt study chair

Sagami Rubber Industries Co., Ltd.

William D Potter, PhD study director

Stapleford Scientific Services Limited

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

Questions about this trial

What is this clinical trial studying?

A study of Contraception and Prevention of Sexually Transmitted Infections, run by Sagami Rubber Industries Co., Ltd. at 1 site in United States.

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 17 inclusion and 11 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 6 Oct 2023. 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 United States. 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?

Yes. Results are posted in the registry (first posted 28 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. (time frame: Self Completion of Questionnaires Within 12 Hours of condom use. Questionnaires returned to investigators when receiving next set of 5 condoms. All sets of questionnaires returned within 9 weeks of couple starting.). 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 NCT04622306, which also lists 1 linked publication.

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 6 Oct 2023.