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A randomized comparative study of interval insertion of three intrauterine devices: the copper T 220c, the Nova T and the WHO levonorgestrel 2 ug IUD.
[Unpublished] 1985 May. 5 p. (Project: 82901)The objective is to compare the effectiveness and acceptability of 3 IUDs inserted in 300 health women, aged 24-38. All have had at least 1 full-term delivery. Subjects were randomly allocated to 1 of the 3 IUDS: the Copper T 220C (Tcu 220c), the Nova T, and the World Health Organization levonorgestrel 2 ug IUD. Insertion was done from the 3rd to the 5th day of menstruation between Feb. and Sept. 1984 and followed up at 48 hours, 3, 6, 12, and 24 months after IUD insertion. 12 month data was collected for cumulative rates, based on life table procedures and analyzed with log-rank test. There was no loss to follow up and no insertion failure. All levonorgestrel IUDs have been removed because the levonorgestrel-releasing IUD has a relatively high risk of ectopic pregnancy. The use-related discontinuation rates of Tcu 220c, Nova T, and levonorgestrel IUD during 12 months of use, were 11.1, 2.4, and 12.7, respectively. The difference between Tcu 220c and Nova T were statistically significant (p.<0.01). The continuation rates of Tcu 220c, Nova T, and levonorgestrel during 6 months of use were 94.0, 99.0, and 96.0, respectively. During 12 months of use, they were 88.9, 97.6, and 87.3 respectively. 1 ectopic pregnancy occurred with the levonorgestrel IUD after 7 months of use. No pregnancy occurred in Nova T users. The pregnancy rates of Tcu 220c and levonorgestrel IUD during 12 months of use were 1.0 and 1.3, respectively. Removal rates for bleeding with Tcu 220c and levonorgestrel IUD during 12 months of use were 3.1 and 1.0, respectively. The removal rate for pain with Tcu 220c during 12 months of use was 2.0. The duration of bleeding and spotting with 3 IUDs, 3, 6, 9, and 12 months of use are illustrated. Preliminary results show that the Nova T is superior to Tcu 220c and levonorgestrel IUDs. Expulsion is the main event in both Nova T and Tcu 220c. More attention should be paid to the insertion technique. The duration of bleeding and spotting of levonorgestrel IUD were longer in the last 3 months after insertion, but was shortest at 1 year of use when compared with Tcu 220c and Nova T.
Effective interception with the levonorgestrel-20-IUD contrarily to WHO advocated Lng-2-microdose IUD. Reply to letter to the editor [letter]
CONTRACEPTION. 1988 Jun; 37(6):644-6.This letter is a response to Professor Haspels' letter criticizing the World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction's clinical study of a 20 mcg microdose levonorgestrel IUD for Contraception (Contraception 1987;35: 363-79). The Population Council's International Committee for Contraceptive Research was provided with the results of the study prior to publication. The feasibility of an IUD that released a dose of progestational steroid that was pharmacologically active only on the endometrium was confirmed in a study conducted between 1980-1982 in 7 centers, only 3 of which were in developing countries. There was no evidence of effects on ovulation and no ectopic pregnancies in this study. The study itself resulted in only 8 ectopic pregnancies (6 with the levonorgestrel device and 2 with copper devices) out of 17,064 woman-years of experience. Nevertheless, the study was terminated and the results published. The polymeric delivery system used in the 2 mcg levonorgestrel IUD had undergone extensive animal toxicological studies in the US and the UK before human use. Moreover, the ethical acceptability of the study was approved by the World Health Organization as well as by local institutional ethic committees and appropriate national authorities.
Effective interception with the levonorgestrel-20-IUD contrarily to WHO advocated Lng-2-microdose IUD [letter]
CONTRACEPTION. 1988 Jun; 37(6):643.The World Health Organization's Special Program of Research, Development, and Research Training in Human Reproduction has investigated microdose administration of levonorgestrel to the uterine cavity and concluded that this approach is not safe or effective. In contrast to the excellent results obtained with 20 mcg of levonorgestrel release per 24 hours, the results of application of only 2 mcg release per 24 hours have been disappointing. There was a 6.7 increased relative risk of ectopic pregnancy with the levonorgestrel 2 IUD compared with the copper IUD, making this an unacceptable form of fertility control. On the other hand, the 12-month pregnancy rate for the levonorgestrel 20 IUD is 0.1/100 woman and the 12-month continuation rate is 80%. Removal rates for menstrual problems with this IUD are only 7.5%, and blood hemoglobin concentrations actually increase among users of the levonorgestrel 20 model.