Quinacrine sterilization of 1997 women in Daharpur, Midnapore, West Bengal, India: a comparison of 3 protocols.

OBJECTIVES: Determine the efficacy of two different dosage regimens of quinacrine placed at each cornual angle, employing a curved inserter, and for fundal placement of doses from 252 mg to 360 mg of quinacrine, depending on the age of the woman.
METHODS: 1. The first trial involved 3 double insertions, a month apart, of 50 mg of quinacrine at each cornual angle. This trial was initiated on 14 August 1979 and completed on 26 June 1984 with 418 subjects admitted. 2. The second was a single double insertion of 100 mg at each cornual angle. This trial, initiated on 30 November 1984, was completed on 11 June 1985 with 100 subjects admitted. 3. The third trial began 2 January 1995, was completed 26 January 1998 and included 1479 subjects. There were 2 insertions, a month apart, with fundal placement of all pellets. The dose depended on the woman's age and ranged from 252 mg in the oldest to 360 mg in the youngest. The cut-off date for this trial was 23 January 2003.
RESULTS: Only relatively minor side effects or complications were seen. None required hospitalization. Failure rates with multiple low dose or single dose cornual placement of pellets were unacceptably high. When higher doses of fundal placement of quinacrine were used at two visits, one month apart, no failures occurred.
CONCLUSIONS: The third protocol shows great promise.