search
Back to results

Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom

Primary Purpose

Sexually Transmitted Diseases

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Synthetic Nitrile Condoms (53mm)
Synthetic Nitrile Condoms (56mm)
Control Latex Condom
Sponsored by
Karex Industries Sdn. Bhd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Diseases focused on measuring Synthetic Male Condom, Slippage-Breakage Study

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion 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 3 months; and intend to continue to be an exclusive (monogamous) sexual relationship with their spouse or partner while participating in this research study; Be sexually active (defined as having at least one vaginal coital act per week); Willing to give informed consent; Willing to complete the male condom coital use reports; Willing to use the study condoms as directed; Agree to use only the study lubricant provided; Agree to only use the study condoms sequentially during time of participation 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; Willing to participate in the study for the duration of 15 condom uses (approximately 3-5 months); Willing to provide photo identification and/or have fingerprint scan to exclude co-enrolment in other research projects; Female partner using hormonal or other non-barrier contraception (e.g. OCs, injectable, implant, IUD, or have had a tubal sterilization) or male partner vasectomised; Agree to return any unopened condoms; Male partner willing to ejaculate during vaginal intercourse; Male partner willing to hold on to the condom ring when withdrawing the erect penis after sexual intercourse; Agree to not bring study condoms in contact with genital or oral piercing jewelry EAH: Both partners have valid personal email and operable mobile phones; Exclusion Criteria: Female partner is pregnant or desires to become pregnant during the time of the research study; Either partner is known to be HIV positive (based on self report [EAH] or documented HIV-negative test result within past two months [MRU]); Self-reported history of recurrent sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia); Male partner has known erectile or ejaculatory dysfunction; Either partner has genital piercing jewelry, uses genital beading or uses sex toys, drugs, medications or non-study devices that can affect sexual performance; Either partner has known sensitivities or allergies to latex, synthetic nitrile, vaginal/sexual lubricants or lubricants used on condoms; Either partner reports symptoms of STI (EAH) or has observable evidence of STI as determined through syndromic diagnosis and vaginal/penile examination (MRU); Either partner is currently participating in another condom study; Either partner is a past or current employee of Essential Access Health, University of the Witwatersrand, or Karex; Either partner is a sex worker.

Sites / Locations

  • Essential Access HealthRecruiting
  • Essential Access HealthRecruiting
  • MRU (MatCH Research Unit)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Synthetic Nitrile Condoms (53mm)

Synthetic Nitrile Condoms (56mm)

Control Latex Condom

Arm Description

53mm width synthetic nitrile condoms

56mm width synthetic nitrile condoms

Commercial natural rubber latex condom

Outcomes

Primary Outcome Measures

Clinical breakage
Clinical breakage is defined as breakage or tearing 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 or torn during sexual intercourse or during withdrawal by the number of male condoms used during vaginal intercourse.
Clinical slippage
Clinical slippage is defined as a condom slipping completely off the penis during sexual intercourse or during withdrawal from the vagina. The clinical slippage rate is calculated by dividing the number of male condoms that slipped by the number of male condoms used during vaginal intercourse.
Clinical failure
A Clinical failure is defined as a clinical breakage or a clinical slippage. The clinical failure rate is calculated by dividing the number of male condoms with a clinical failure by the number of male condoms used during vaginal intercourse.

Secondary Outcome Measures

Genital discomfort
Rates of genital discomfort reported to have occurred during or immediately after condom use. Genital adverse events will be classified by relatedness, expectedness and severity.
Acceptability
Frequency of key acceptability outcome measures 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.
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.
Non-Clinical slippage
Defined as slippage along the shaft of the penis during sexual intercourse (but not completely off the penis). Non-clinical slippage is slippage with no potential adverse clinical consequences. The non-clinical slippage rate is calculated by dividing the number of male condoms reported to have partially slipped during sexual intercourse by the number of male condoms used during vaginal intercourse.

Full Information

First Posted
June 12, 2023
Last Updated
June 12, 2023
Sponsor
Karex Industries Sdn. Bhd.
Collaborators
University of Witwatersrand, South Africa, Essential Access Health, Sigma3 Services SARL
search

1. Study Identification

Unique Protocol Identification Number
NCT05912283
Brief Title
Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom
Official Title
A Functional Performance and Acceptability Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karex Industries Sdn. Bhd.
Collaborators
University of Witwatersrand, South Africa, Essential Access Health, Sigma3 Services SARL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This is a multi-site, randomised 3-period cross-over trial evaluating the functional performance of two synthetic nitrile male condoms against a control latex male condom.
Detailed Description
A sequential randomised 3-period cross-over trial comparing five uses of two synthetic nitrile male condoms of different sizes with a control latex male condom. Each couple will be asked to use five synthetic nitrile condoms (53 mm width), five synthetic nitrile condoms (56 mm width) and five latex male condoms (53 mm width) in a randomised order. Couples will complete a Condom Use Report after each condom use. Function, safety, and acceptability will be assessed at each of three follow-up visits conducted after using each set of five condoms. The trial will enrol 300 couples, anticipating that at least 255 couples will complete the study. Half of the couples (150) will be enrolled in Durban, South Africa and half (150) enrolled in California USA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Diseases
Keywords
Synthetic Male Condom, Slippage-Breakage Study

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A sequential randomised 3-period cross-over trial comparing the functional performance of two synthetic male condoms against a control latex male condom.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Each product will be labeled with a randomly generated code.
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Synthetic Nitrile Condoms (53mm)
Arm Type
Experimental
Arm Description
53mm width synthetic nitrile condoms
Arm Title
Synthetic Nitrile Condoms (56mm)
Arm Type
Experimental
Arm Description
56mm width synthetic nitrile condoms
Arm Title
Control Latex Condom
Arm Type
Active Comparator
Arm Description
Commercial natural rubber latex condom
Intervention Type
Device
Intervention Name(s)
Synthetic Nitrile Condoms (53mm)
Intervention Description
53mm width synthetic nitrile condoms
Intervention Type
Device
Intervention Name(s)
Synthetic Nitrile Condoms (56mm)
Intervention Description
56mm width synthetic nitrile condoms
Intervention Type
Device
Intervention Name(s)
Control Latex Condom
Intervention Description
Commercial natural rubber latex condom
Primary Outcome Measure Information:
Title
Clinical breakage
Description
Clinical breakage is defined as breakage or tearing 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 or torn during sexual intercourse or during withdrawal by the number of male condoms used during vaginal intercourse.
Time Frame
3 - 5 months
Title
Clinical slippage
Description
Clinical slippage is defined as a condom slipping completely off the penis during sexual intercourse or during withdrawal from the vagina. The clinical slippage rate is calculated by dividing the number of male condoms that slipped by the number of male condoms used during vaginal intercourse.
Time Frame
3 - 5 months
Title
Clinical failure
Description
A Clinical failure is defined as a clinical breakage or a clinical slippage. The clinical failure rate is calculated by dividing the number of male condoms with a clinical failure by the number of male condoms used during vaginal intercourse.
Time Frame
3 - 5 months
Secondary Outcome Measure Information:
Title
Genital discomfort
Description
Rates of genital discomfort reported to have occurred during or immediately after condom use. Genital adverse events will be classified by relatedness, expectedness and severity.
Time Frame
3 - 5 months
Title
Acceptability
Description
Frequency of key acceptability outcome measures 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.
Time Frame
3 - 5 months
Title
Non-Clinical breakage
Description
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.
Time Frame
3 - 5 months
Title
Non-Clinical slippage
Description
Defined as slippage along the shaft of the penis during sexual intercourse (but not completely off the penis). Non-clinical slippage is slippage with no potential adverse clinical consequences. The non-clinical slippage rate is calculated by dividing the number of male condoms reported to have partially slipped during sexual intercourse by the number of male condoms used during vaginal intercourse.
Time Frame
3 - 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion 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 3 months; and intend to continue to be an exclusive (monogamous) sexual relationship with their spouse or partner while participating in this research study; Be sexually active (defined as having at least one vaginal coital act per week); Willing to give informed consent; Willing to complete the male condom coital use reports; Willing to use the study condoms as directed; Agree to use only the study lubricant provided; Agree to only use the study condoms sequentially during time of participation 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; Willing to participate in the study for the duration of 15 condom uses (approximately 3-5 months); Willing to provide photo identification and/or have fingerprint scan to exclude co-enrolment in other research projects; Female partner using hormonal or other non-barrier contraception (e.g. OCs, injectable, implant, IUD, or have had a tubal sterilization) or male partner vasectomised; Agree to return any unopened condoms; Male partner willing to ejaculate during vaginal intercourse; Male partner willing to hold on to the condom ring when withdrawing the erect penis after sexual intercourse; Agree to not bring study condoms in contact with genital or oral piercing jewelry EAH: Both partners have valid personal email and operable mobile phones; Exclusion Criteria: Female partner is pregnant or desires to become pregnant during the time of the research study; Either partner is known to be HIV positive (based on self report [EAH] or documented HIV-negative test result within past two months [MRU]); Self-reported history of recurrent sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia); Male partner has known erectile or ejaculatory dysfunction; Either partner has genital piercing jewelry, uses genital beading or uses sex toys, drugs, medications or non-study devices that can affect sexual performance; Either partner has known sensitivities or allergies to latex, synthetic nitrile, vaginal/sexual lubricants or lubricants used on condoms; Either partner reports symptoms of STI (EAH) or has observable evidence of STI as determined through syndromic diagnosis and vaginal/penile examination (MRU); Either partner is currently participating in another condom study; Either partner is a past or current employee of Essential Access Health, University of the Witwatersrand, or Karex; Either partner is a sex worker.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mags Beksinska, PhD
Phone
+27-310011916
Email
mbeksinska@mru.ac.za
First Name & Middle Initial & Last Name or Official Title & Degree
Terri Walsh, MPH
Phone
2133865614
Ext
4589
Email
TWalsh@essentialaccess.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mags Beksinska, PhD
Organizational Affiliation
MatCH Research Unit (MRU)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Essential Access Health
City
Berkeley
State/Province
California
ZIP/Postal Code
94710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terri Walsh, MPH
Phone
213-386-5614
Ext
4589
Email
TWalsh@essentialaccess.org
First Name & Middle Initial & Last Name & Degree
Terri Walsh, MPH
Facility Name
Essential Access Health
City
Los Angeles
State/Province
California
ZIP/Postal Code
90010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terri Walsh, MPH
Phone
213-386-5614
Ext
4589
Email
TWalsh@essentialaccess.org
First Name & Middle Initial & Last Name & Degree
Terri Walsh, MPH
Facility Name
MRU (MatCH Research Unit)
City
Durban
State/Province
Kwa-Zulu Natal
ZIP/Postal Code
4001
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mags Beksinska, PhD
Phone
+27310011916
Email
mbeksinska@mru.ac.za
First Name & Middle Initial & Last Name & Degree
Mags Beksinska, PhD
First Name & Middle Initial & Last Name & Degree
Fathima Fathima, phD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom

We'll reach out to this number within 24 hrs