TITLE SAGCS2 Protocol 2.3 + Amend 1

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05763264
• Other study ID #: SAGCS2 Protocol 2.3 + Amend 1
• Status: Completed
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2023
• Source: Sagami Rubber Industries Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 30, 2021
• Est. primary completion date: December 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception
• Prevention of Sexually Transmitted Infections
• Sexually Transmitted Diseases

Intervention

Device:
• Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B
Condom functionality study to determine failure rates

Locations

Country	Name	City	State
United States	Essential Access Health	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Sagami Rubber Industries Co., Ltd.	Essential Access Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.