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Promoting CSD500 Use Among Women in Established Relationships

Status
Planned
Phase
Open Label
Principal Investigator(s)
Maria Gallo, PhD
Objective

A new condom, CSD500, containing an erectogenic drug was developed for use among healthy couples to improve sexual pleasure by increasing penile firmness, size and erection duration. The overall objective of the proposed two-arm randomized trial is to test whether promoting the novel condom CSD500 for improved sexual pleasure results in couples having less unprotected vaginal sex. 

Prevention Option(s)
Male and Female Condoms
Multipurpose Prevention Technologies
Study Design
Open label
Arms and Assigned Interventions
Description
CSD500 Condom The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.
ARMs
Experimental
Description
Standard condom The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.
ARMs
Placebo Comparator
Trial Sponsors
Ohio State University, Vietnam: Ministry of Health, University of North Carolina, Chapel Hill
March 2017
March 2020
Enrollment
500
18
Years
45
Years
Population
Women
Men
Sites

Thanh Hoa Provincial Centre of Reproductive Health

Thanh Hoa
Vietnam