Abstract

PIP: This study describes a clinical evaluation of the Progesterone T IUD which releases a daily dose of 65 mcg of progesterone. The device is made of a copolymer of ethylene vinyl and has a transversal arm measuring 3.18 cm and a longitudinal arm 3.61 cm. The longitudinal arm contains 38 mg of natural progesterone, Barium sulfate, and silicone acetate. 146 new users of the Progesterone T were compared with 149 using the Copper 7 Gravigarde. Patients in both groups ranged in age from 17-40 years with an average of 27.2 for Progesterone T and 27.1 for Copper 7 users. Parity ranged from 1-11 with an average of 2.8 for the Progesterone T group and from 1-10 with an average of 2.7 for the Copper 7 group. The average number of spontaneous abortions was .7 for the Progesterone T group and .5 for the Copper 7 group. The groups were also comparable in previous contraceptive usage. In another study, 51 Lippes Loop D users, 52 Progesterone T users, and 50 Copper 7 users were evaluated for menstrual and intermenstrual blood loss in the 3 months prior to and the 1st, 2nd, 4th, 6th, 9th, and 12th months after insertion. At the end of 12 months, the Progesterone T and Copper 7 users respectively had pregnancy rates of 1.4 and 1.5, expulsion rates of 4.2 and 5.8, rates of removal for medical reasons of 2.8 and 3.0, and continuation rates of 87.2 and 84.6. After 1569 women-months of Progesterone T use and 1558 of Copper 7 use there were no statistically significant differences. With the Progesterone T there was 1 removal for pain, 1 for pelvic inflammation, and 2 for menstrual alterations. 4 Copper 7s were removed for bleeding. The average duration of menstrual bleeding was 6.0 days with the Progesterone T and 6.2 with the Copper 7. The number of days of true bleeding were 4.8 on average for the Progesterone T and 5.3 for the Copper 7. Intermenstrual bleeding was twice as common for the Progesterone T. There was no statistically significant difference in incidence of pain reported by the 2 groups at the beginning and end of the study. Both groups had a decline in pain at the end of the study, with the Progesterone T having a slightly more pronounced decline. The average volume of menstrual blood loss increased by 87.8% after insertion of the Lippes Loop D and by 24.3% with the Copper 7 but declined by 44.5% for the Progesterone T.