Evaluation of Polyurethane Male Condoms

NCT04622306 | Completed Results FDA Device

• 1 other identifier: SAGCS 2
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Contraception; Prevention of Sexually Transmitted Infections

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (3)

Control Latex Condom C

ACTIVE COMPARATOR

Commercial Natural Rubber Latex Male Condom

Device: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B

Polyurethane Condom A

EXPERIMENTAL

Polyurethane Condom A (002)

Device: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B

Polyurethane Condom B

EXPERIMENTAL

Polyurethane Condom B (001)

Device: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B

Interventions

Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B DEVICE

Condom functionality study to determine failure rates

Control Latex Condom C; Polyurethane Condom A; Polyurethane Condom B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sagami Rubber Industries Co., Ltd.: lead
• Essential Access Health: collaborator

Study Sites (1)

Essential Access Health

Los Angeles, California, 90010-2648, United States

Location

Related Publications (1)

• 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.

  PMID: 39232840 DERIVED

Limitations and Caveats

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).

Results Point of Contact

• Title: Mr Grant R Burt
• Organization: Sagami

grantburt@sagami-europe.com

+33 607 54 52 41

Study Officials

• Grant R Burt

  Sagami Rubber Industries Co., Ltd.

  STUDY CHAIR

• William D Potter, PhD

  Stapleford Scientific Services Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 9, 2020
• Study Start: October 12, 2020
• Primary Completion: December 6, 2021
• Study Completion: December 30, 2021
• Last Updated: October 6, 2023
• Results First Posted: June 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)