Clinical trial NCT05073770: A Clinical Feasibility Study to Assess the Performance of a Latex Condom in Healthy Monogamous Couples.
Official title: A Clinical Feasibility Study to Assess the Performance of a Latex Condom in Healthy Monogamous Couples.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Performance of a New Condom
Lead sponsor: Titan Condoms, LLC
Sponsor class: INDUSTRY
Collaborators: name: STATCure Consulting Services Inc.
First posted: 2021-10-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Performance (clinical slippage rate)
timeFrame: two-weeks
measure: Performance (clinical breakage rate)
timeFrame: two-weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: