Effectiveness of Device to Simplify/increase Condom Use

Period of Performance: 06/15/1995 - 12/15/1995

Unknown

Phase 1 SBIR

Recipient Firm

Condax, LLC
Rockville Centre, NY 11570
Principal Investigator

Abstract

Long-Term Objectives: Determine effectiveness and safe utilization of small innovative device which, attached to unrolled condom, will simultaneously self test for condom integrity and facilitate usage. This dependable applicator and condom system (CONDAX) will offset universal reluctance toward condom usage and mitigate associated health risks. Specific Objectives Phase I: 1) Evaluate and optimize existing applicator prototype design. 2) Test optimized functional prototypes at independent lab following FDA new testing requirements. 3) Conduct 9 focus groups on CONDAX benefits and behavioral aspects on usage. 4) Refine instruments based on above. 5) Conduct clinical trials on 32 adult couples using cross sectional repeated measures design with alternating treatments. 6) Conduct data analysis of all above. 7) Develop enlarged Phase II controlled design based on above to scientifically evaluate CONDAX effectiveness. Phase I will explore feasibility/reliability of above design and assess CONDAX physical characteristics and attitudes towards it's use. Benefits: l) CONDAX self tests for condom integrity beyond F.D.A. manufacturing allowance of 4 failures (holes) per 1000 condoms. 2) CONDAX will increase condom usage thus minimizing disease transmission and unwanted pregnancies. (Research results should allow for the commercialization of a cost effective and safe CONDAX with greater appeal to populations choosing to practice safe sex and/or birth control.) PROPOSED COMMERCIAL APPLICATION: The potential commercial application for the patented condax is vast. It's advantages in self testing for condom integrity and ease of application are expected to significantly increase condom use at minimal cost (15 cents/applicator). Even if only a small percentage of existing condom users would use Condax and another small percent begin to use them, the contribution to the U.S. health care system (and to Condax becoming a commercial success) would be immense.