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

NCT ID: NCT05912283

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-02
• Study Completion Date: 2024-01-31

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.

Conditions

Sexually Transmitted Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Synthetic Nitrile Condoms (53mm)

53mm width synthetic nitrile condoms

Group Type: EXPERIMENTAL

Synthetic Nitrile Condoms (53mm)

Intervention Type: DEVICE

53mm width synthetic nitrile condoms

Synthetic Nitrile Condoms (56mm)

56mm width synthetic nitrile condoms

Group Type: EXPERIMENTAL

Synthetic Nitrile Condoms (56mm)

Intervention Type: DEVICE

56mm width synthetic nitrile condoms

Control Latex Condom

Commercial natural rubber latex condom

Group Type: ACTIVE_COMPARATOR

Control Latex Condom

Intervention Type: DEVICE

Commercial natural rubber latex condom

Interventions

Synthetic Nitrile Condoms (53mm)

53mm width synthetic nitrile condoms

Intervention Type: DEVICE

Synthetic Nitrile Condoms (56mm)

56mm width synthetic nitrile condoms

Intervention Type: DEVICE

Control Latex Condom

Commercial natural rubber latex condom

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Be between the ages of 18 and 45 years (inclusive);

2. Be literate (able to read a newspaper or letter easily);

3. 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;

4. Be sexually active (defined as having at least one vaginal coital act per week);

5. Willing to give informed consent;

6. Willing to complete the male condom coital use reports;

7. Willing to use the study condoms as directed;

8. Agree to use only the study lubricant provided;

9. Agree to only use the study condoms sequentially during time of participation

10. Willing to adhere to the follow-up schedule and all study procedures;

11. Willing to provide research study staff with an address, phone number or other locator information while participating in the study;

12. Willing to participate in the study for the duration of 15 condom uses (approximately 3-5 months);

13. Willing to provide photo identification and/or have fingerprint scan to exclude co-enrolment in other research projects;

14. 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;

15. Agree to return any unopened condoms;

16. Male partner willing to ejaculate during vaginal intercourse;

17. Male partner willing to hold on to the condom ring when withdrawing the erect penis after sexual intercourse;

18. Agree to not bring study condoms in contact with genital or oral piercing jewelry

19. EAH: Both partners have valid personal email and operable mobile phones;

Exclusion Criteria

1. Female partner is pregnant or desires to become pregnant during the time of the research study;

2. Either partner is known to be HIV positive (based on self report [EAH] or documented HIV-negative test result within past two months [MRU]);

3. Self-reported history of recurrent sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia);

4. Male partner has known erectile or ejaculatory dysfunction;

5. Either partner has genital piercing jewelry, uses genital beading or uses sex toys, drugs, medications or non-study devices that can affect sexual performance;

6. Either partner has known sensitivities or allergies to latex, synthetic nitrile, vaginal/sexual lubricants or lubricants used on condoms;

7. Either partner reports symptoms of STI (EAH) or has observable evidence of STI as determined through syndromic diagnosis and vaginal/penile examination (MRU);

8. Either partner is currently participating in another condom study;

9. Either partner is a past or current employee of Essential Access Health, University of the Witwatersrand, or Karex;

10. Either partner is a sex worker.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Witwatersrand, South Africa

OTHER

Sponsor Role: collaborator

Essential Access Health

OTHER

Sponsor Role: collaborator

Sigma3 Services SARL

UNKNOWN

Sponsor Role: collaborator

Karex Industries Sdn. Bhd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mags Beksinska, PhD

Role: PRINCIPAL_INVESTIGATOR

MatCH Research Unit (MRU)

Locations

Essential Access Health

Berkeley, California, United States

Essential Access Health

Los Angeles, California, United States

MRU (MatCH Research Unit)

Durban, KwaZulu-Natal, South Africa

Countries

United States; South Africa

Other Identifiers

Karex02

Identifier Type: -

Identifier Source: org_study_id