TITLE SAGCS2 Protocol 2.3 + Amend 1

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.

Study Overview

• Status: Completed
• Conditions: Contraception; Prevention of Sexually Transmitted Infections
• Intervention / Treatment: Device: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90010-2648
      • Essential Access Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Between the ages of 18 and 45 (inclusive)
2. Protected against pregnancy by oral contraceptives, an IUD, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
3. Have home internet access, a valid personal email for each partner, ability to videoconference and use electronic signature technology
4. Willing and able to give electronic informed consent
5. Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms via interview or self-administered questionnaires
6. Have vaginal intercourse at least once weekly
7. Willing to use the study products for fifteen acts of vaginal intercourse within nine weeks of study entry
8. 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
9. Both study partners have previous experience using male condoms
10. Agree not to use any additional vaginal or sexual lubricant except the AstroglideTM product provided, if desired, supplied by the study
11. Agree not to expose the study condoms to jewelry (hand, facial, or genital) or piercings (facial or genital) that could damage the study condoms.
12. Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms
13. Male partner agrees to ejaculate during vaginal intercourse
14. Agree to (or partner) hold the condom at the base of the erect penis during withdrawal
15. Agree to return any condoms that break during use
16. Agree to return any unopened condoms
17. Reachable by telephone

Exclusion Criteria:

1. Currently participating in another similar clinical study
2. Female partner self-reported as pregnant
3. Allergic to natural rubber latex or polyurethane, or has a history of recurrent adverse events following use of latex or polyurethane products
4. Unable to follow study requirements, use instructions or attend study visits or exchanges
5. 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.)
6. Currently using condoms for protection against a known STI
7. Taking any internally applied medication to treat a genital condition that could interact with the study condom
8. 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
9. Male has had a prostatectomy
10. 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
11. Employee or affiliate of Essential Access Health or Sagami Rubber Industries Co., Ltd.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Latex Condom C; Commercial Natural Rubber Latex Male Condom	Device: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B; Condom functionality study to determine failure rates
Experimental: Polyurethane Condom A; Polyurethane Condom A (002)	Device: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B; Condom functionality study to determine failure rates
Experimental: Polyurethane Condom B; Polyurethane Condom B (001)	Device: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B; Condom functionality study to determine failure rates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Confirm Non Inferiority of Experimental Condoms verses 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.	Self Completion of Questionnaires Within 12 Hours of Use.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability Measures	Acceptability Evaluation by Comparing Physical Attributes and Perceptions about Each Condom Type Using a Linear Scale Ranging from 1. Strongly Agree to 7. Strongly Agree.	Self Completion of Questionnaires Within 12 Hours of Use.

Collaborators and Investigators

• Sponsor: Sagami Rubber Industries Co., Ltd.
• Collaborators: Essential Access Health
• Investigators: Study Chair: Grant R Burt, Sagami Rubber Industries Co., Ltd.; Study Director: William D Potter, PhD, Stapleford Scientific Services Limited

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Actual): December 6, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Estimate): March 10, 2023

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: SAGCS2 Protocol 2.3 + Amend 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No