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Evaluation of Synthetic Nitrile Male Condom Compared to Standard Latex Male Condom

Primary Purpose

Sexually Transmitted Diseases

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Synthetic Nitrile Condom (61mm)
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 10 condom uses (approximately 2-3 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, Intrauterine device (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; Former participant in Karex02 Study: male partner measures at least 118 mm in girth of erect penis. Agree that information provided in Karex02 study may be used and combined with the information in this study 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; 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 Type

Experimental

Active Comparator

Arm Label

Synthetic Nitrile Condom (61mm)

Control Latex Condom

Arm Description

61mm width synthetic Nitrile condoms

61mm width Natural Rubber Latex condoms

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
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 i.e Comfort in use, ease of fitting and removal, like or dislike of product attributes, adequacy and feel of lubrication.
Questionnaires obtained after participants complete 5 condom uses of each condom type cover multiple acceptability factors. For these acceptability measures, Likert scores ranging from 1 (lowest) to 5 (highest) will be compared across condom types.
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
September 20, 2023
Last Updated
October 9, 2023
Sponsor
Karex Industries Sdn. Bhd.
Collaborators
Match Research, Essential Access Health, Sigma3 Services SARL
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1. Study Identification

Unique Protocol Identification Number
NCT06079060
Brief Title
Evaluation of Synthetic Nitrile Male Condom Compared to Standard Latex Male Condom
Official Title
A Functional Performance and Acceptability Evaluation of Synthetic Nitrile Male Condom Compared to a Standard Latex Male Condom
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karex Industries Sdn. Bhd.
Collaborators
Match Research, 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

5. Study Description

Brief Summary
Thia is a multi-site, randomised 2-period cross-over trial comparing five uses of a 61 mm width synthetic nitrile male condom with five uses of a 61 mm width standard latex male condom.
Detailed Description
A sequential randomised 2-period cross-over trial comparing five uses of a 61 mm width synthetic nitrile male condom with five uses of a 61 mm width standard latex male condom. Each couple will be asked to use five synthetic nitrile condoms, and five latex control male condoms 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 two follow-up visits conducted after using each set of five condoms. The trial will enrol up to 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 2-period cross-over trial comparing five uses of a 61 mm width synthetic nitrile male condom with five uses of a 61 mm width standard 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 Condom (61mm)
Arm Type
Experimental
Arm Description
61mm width synthetic Nitrile condoms
Arm Title
Control Latex Condom
Arm Type
Active Comparator
Arm Description
61mm width Natural Rubber Latex condoms
Intervention Type
Device
Intervention Name(s)
Synthetic Nitrile Condom (61mm)
Intervention Description
61mm width Synthetic Nitrile Condoms
Intervention Type
Device
Intervention Name(s)
Control Latex Condom
Intervention Description
61mm width 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
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 i.e Comfort in use, ease of fitting and removal, like or dislike of product attributes, adequacy and feel of lubrication.
Description
Questionnaires obtained after participants complete 5 condom uses of each condom type cover multiple acceptability factors. For these acceptability measures, Likert scores ranging from 1 (lowest) to 5 (highest) will be compared across condom types.
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 10 condom uses (approximately 2-3 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, Intrauterine device (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; Former participant in Karex02 Study: male partner measures at least 118 mm in girth of erect penis. Agree that information provided in Karex02 study may be used and combined with the information in this study 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; 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
MRU (MatCH Research Unit)
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
Phone
213-386-5614
Email
twalsh@essentialaccess.org
First Name & Middle Initial & Last Name & Degree
Terri Walsh
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
Phone
213-386-5614
Email
twalsh@essentialaccess.org
First Name & Middle Initial & Last Name & Degree
Terri Walsh
Facility Name
MRU (MatCH Research Unit)
City
Durban
ZIP/Postal Code
4000
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mags Beksinska
Phone
+27310011916
Email
mbeksinska@mru.ac.za
First Name & Middle Initial & Last Name & Degree
Mags Beksinska
First Name & Middle Initial & Last Name & Degree
Fathima Mahomed

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Synthetic Nitrile Male Condom Compared to Standard Latex Male Condom

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