Clinical studies of spermicides for prophylaxis against sexually transmitted diseases.

Study design and preliminary data are discussed from 4 clinical trials of vaginal spermicides for prophylaxis against sexually transmitted diseases in high-risk groups from Costa Rica the Dominican Republic and Bogota and Ibague Colombia. Some of the issues in study design are compliance and predictability of prostitute subjects convenience and acceptability of the product definition of loss to follow-up staff and laboratory cooperation and legal status of prostitutes in the locality. It was decided that an 8-week study optimal. 4 days grace was allowed for attendance at appointments. It was best to recruit a much larger pool of women from whom to select reliable subjects. It was important to emphasize truthful completion of diaries rather than perfect use of the test products. Study subjects had at least 1 diagnoses STD within the last year and 2 or more sexual partners within 30 days. Demographic information frequency of coitus number of partners and product use were reported as of 4 weeks in the Bogota Colombia study. These results were good because of excellent relationships between investigator and staff and study participants.