Comparison of Norethindrone-Containing OCPs to Desogestrel OCPs and Depo-Provera in Women

This second summary report details the specific activities that have occurred during Year 2 of funding September 23, 1997 through September 22, 1998. According to the SOW, 3 major objectives and related tasks were to be addressed during this period. Significant progress across each major objective was achieved. Recruitment was extended and will end on 31 October, 1998. To date, a total of 366 women have completed their initial medical visit with a projected enrollment of 375 women. Significant increases in enrollment at both sites was due to direct mail solicitation, hiring of a full-time research assistant, and HURRAD approval for a protocol change to modify the contraceptive wash-out period from 90 to 30 days for birth control pills and from 6 to 3 months for DMPA. Follow-up visits for the cohort have been excellent with 213, 148, and 40 subjects completing the 3, 6, and 12-month visits, respectively. Moreover, contraceptive discontinuation is projected to be significantly smaller than anticipated as only 53 14.5 women have discontinued their chosen contraceptive. Thus, our projected cohort of 375 women will allow use to meet all technical objectives.