A Clinical Feasibility Study to Assess the Performance of a Latex Condom in Healthy Monogamous Couples.

Study Overview
=================
Brief Summary
-----------------
The U.S. Centers for Disease Control and Prevention has recommended the male latex condom as the best physical barrier for preventing HIV and sexually transmitted disease (STD) transmission. Condoms are a safe and effective form of contraception that have 98% effectiveness in protecting against STD and pregnancy. However, evidence shows that if a condom does not fit properly, its impact can reduce to 85% or less, as it may slip off during sex or during removal of the penis from the vagina or breaks during intercourse. Condoms need to fit correctly to guard against fluids and exposed skin which could lead to STD contraction or pregnancy. To choose the right size, the girth (the width of an erect penis) is the most important factor, not length. However, most condom companies do not list their nominal width, let alone base their sizes off girth. In addition, most brands usually offer XL as only 56 mm based on a misconception that one size fits all and that XL condoms are big enough. But that is far from the truth, and several men complain about the lack of simplicity and intuitiveness when finding a condom that fits them. To address this gap, after a long two years of development, Titan company was able to engineer four distinct sizes so that each man can easily find the condom he needs. This study aims to obtain a preliminary estimate of slippage and breakage of Titan's new condom (64mm or 69mm) during use.

Official Title
-----------------
A Clinical Feasibility Study to Assess the Performance of a Latex Condom in Healthy Monogamous Couples.

Conditions
-----------------
Performance of a New Condom

Intervention / Treatment
-----------------
* Device: Titan Condom


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Couples not at risk of pregnancy (using alternate contraception). Couples who are past or recent/experienced condom users No known sexually transmitted infections, including HIV/AIDS, gonorrhea, chlamydia, etc. Subjects between 18 to 45 years of age. Monogamous heterosexual couples who agree to practice vaginal sex only during the study. The Titan Size Guide will be used to determine subject eligibility based on the following penis girth measurements Penis girth N64 ≥ 5.8 Penis girth N69 ≥ 6.1 Exclusion Criteria: Couples who work for the clinical testing laboratory or who are relatives of staff of the clinical test laboratory or a sponsor of the study. Participants with known allergy to natural rubber latex or material(s) of test condom. Participants with known sensitivity to the residual chemicals used in the manufacturing of natural rubber latex condoms. Couples where one knowingly has a sexually transmitted infection. Male partners have known erectile or ejaculatory dysfunction. Commercial sex workers. Female partner is pregnant or desires to become so while participating in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N64<br>Based on the penis girth measurements, eligible participants will be assigned to two groups: Group 1: The couples who will test the 64 mm plain condom (n=25). The test condom has the following specifications throughout the study: The plain 64mm condom (i.e., N64): Length 223 ±5mm, width 64±1mm, thickness (single wall) 0.070± 0.005mm, and beading thickness 1.25±0.05mm. | Device: Titan Condom<br>* The test condoms have the following specifications throughout the study: The plain 64mm condom (i.e., N64): Length 223 ±5mm, width 64±1mm, thickness (single wall) 0.070± 0.005mm, and beading thickness 1.25±0.05mm. The plain 69mm condom (i.e., N69): Length 223 ±5mm, Width 69±1mm, Thickness (single wall) 0.070± 0.005mm, Beading thickness 1.25±0.05mm.<br>|
| Experimental: N69<br>Based on the penis girth measurements, eligible participants will be assigned to two groups: Group 2: The couples who will test the 69 mm plain condom (n=25). The test condom has the following specifications throughout the study: The plain 69mm condom (i.e., N69): Length 223 ±5mm, Width 69±1mm, Thickness (single wall) 0.070± 0.005mm, Beading thickness 1.25±0.05mm. | Device: Titan Condom<br>* The test condoms have the following specifications throughout the study: The plain 64mm condom (i.e., N64): Length 223 ±5mm, width 64±1mm, thickness (single wall) 0.070± 0.005mm, and beading thickness 1.25±0.05mm. The plain 69mm condom (i.e., N69): Length 223 ±5mm, Width 69±1mm, Thickness (single wall) 0.070± 0.005mm, Beading thickness 1.25±0.05mm.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance (clinical slippage rate) | Clinical slippage rate will be calculated as the number of condoms with at least 1 clinical slippage event divided by the number of condoms used during intercourse, reported as a percentage. Clinical slippage events, defined in ISO 29943-1:2017, will be reported by subjects. A clinical slippage is defined as a condom slipping off completely during intercourse or during withdrawal from the vagina. Slippage that occurs because the user failed to hold onto the condom at the base of the penis during withdrawal and/ or because the user delayed withdrawal after sex are to be record as non-clinical slippage, these events are considered user failures. | two-weeks | 
| Performance (clinical breakage rate) | Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event (clinical slippage or clinical breakage) divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, will be reported by subjects. | two-weeks |