Carl Gustaf Nilsson, M.D. t:j: Hannu Allonen, M.D. Juan Diaz, M.D.II Tapani Luukkainen, M.D., Ph.D.t

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1 FERTILITY AND STERILITY Copyright The American Fertility Society Vol. 39, No.2, February 1983 Printed in U.8A. Two years' experience with two levonorgestrel-releasing intrauterine devices and one copper-releasing intrauterine device: a randomized comparative performance study* Carl Gustaf Nilsson, M.D. t:j: Hannu Allonen, M.D. Juan Diaz, M.D.II Tapani Luukkainen, M.D., Ph.D.t University of Helsinki, Helsinki, Finland, University of Turku, Turku, Finland, and Centro de Pesquisas e Cantrale das Doencas Materna-Infantis de Campinas-CEMICAMP, Sao Paulo, Brazil A randomized comparative performance study of two levonorgestrel intrauterine devices (IUDs) and a copper (Nova-T) IUD (Leiras, Turku, Finland) was performed at two clinics in Finland and one in Brazil. The 24-month cumulative event rates per 100 women are reported. Six thousand woman-months of use were recorded with the levonorgestrel IUD and 3000 with the Nova-T device. Pregnancy rates at 2 years of use were 0.6 and 0 with the two levonorgestrel IUDs and 3.3 with the Nova-T IUD. Removal rates because of bleeding and/or pain were low with all three IUDs: 7.5, 7.6, and 7.1, respectively, at 24 months. Recordings of the number of days of bleeding showed significantly fewer days of bleeding during use of the levonorgestrel IUDs than the Nova-T IUD from the second month of use onward, until the end of the second year. No infections were recorded in association with use of the levonorgestrel IUDs, and only one termination because of infection was recorded for the Nova-T IUD. The continuation rates of use at 24 months were 66.6, 60.7, and 71.9 for the two levonorgestrel IUDs and the Nova-T IUD, respectively; the differences were not statistically significant. Fertil Steril 39:187, 1983 Received May 20, 1982; revised and accepted October 7, *This work was undertaken as part of the contraceptive development programs sponsored and coordinated by the International Committee for Contraception Research and the Population Council, New York, New York. Financial support was provided by the International Development Research Center of Canada, the Ford Foundation, and the Rockefeller Foundation, New York, New York. tsteroid Research Laboratory, Department of Medical Chemistry, University of Helsinki. treprint requests: Dr. Carl Gustaf Nilsson, Steroid Research Laboratory, Department of Medical Chemistry, University of Helsinki, Siltavuorenpenger 10 A, SF Helsinki 17, Finland. Department of Pharmacology, Institute of Biomedicine, University of Turku. IICentro de Pesquisas e Controle das Doencas Materno-Infantis de Campinas-CEMICAMP. When the development of a new contraceptive method has reached the state of clinical trials, a comparison with an established, well-performing method becomes necessary. The so-called clinic effect is a recognized feature in studies of intrauterine contraceptive devices (IUDs).l To avoid the bias imposed by this phenomenon, IUD studies should be comparative and randomized. The choice of the object of comparison in IUD studies has often been the CuT -200 device (Leiras, Turku, Finland). The development of the new levonorgestrel-releasing IUD is now in the phase of clinical trials. The first results of these studies have been published. 2, 3 The trials have been conducted as randomized comparative performance studies, using the Nova-T copper-releasing IUD Vol. 39, No.2, February,1983 Nilsson et ai. Levonorgestrel IUD: 2 years' experience 187

2 % Levonorgestrel A D Levonorgestrel B Nova -T < >35 Age Figure 1 Age distribution of the patients. (Leiras) for comparison. The choice of the Nova-T for this comparison was made because the levonorgestrel-releasing IUD utilizes the plain Nova T design as the carrier for levonorgestrel and because the Nova-T has shown better clinical performance in multicenter randomized trials in comparison with the CuT-200.4, 5 This report covers the first-segment 2-year cumulative net rates per 100 women using two levonorgestrel-releasing IUDs and the Nova-T device. MATERIALS AND METHODS The IUDs were inserted at three different outpatient clinics, two in Finland and one in Brazil. Similar insertion instructions and criteria for patient enrollment were used at all three clinics. Special admission and follow-up forms and cards for registering bleeding were designed for the study. The three IUDs were assigned at random, and the women were not told which of the three IUDs was inserted. The admission form was sealed after insertion, and the study was thereafter carried out double-blind. After the 1-year follow-up visit, the women were told on request which IUD had been inserted. The device was inserted between the third and seventh day of the cycle. No additional contraception was used after the insertion. Follow-up visits were scheduled at 3, 6, 12, and 24 months after insertion. Three different IUDs were used, two levonorgestrel-releasing IUDs and one copper-releasing Nova-T device. The properties of all three IUDs have been described in detail. 6,7 The levonorgestrel IUDs were called A and B, and the difference between them was only in the amount of 188 Nilsson et al. Levonorgestrel IUD: 2 years' experience levonorgestrel released daily in utero. Device A was designed to release 20 ILg, and device B, 30 ILg of levonorgestrel daily. The insertion technique was identical for all three devices. Voluntary patients were enrolled for the study by the following criteria: accessibility for regular follow-up; a history of at least one pregnancy, age between 18 and 38 years; not pregnant or breastfeeding at the start of the study; no former use of a long-acting hormonal preparation; and no hormonal treatment in the previous 6 months. Patients with a history of ectopic pregnancy were excluded, but no other exclusions were made on the grounds of medical history if at the time of enrollment the patient was regarded as being healthy. Informed consent was obtained from every patient. The following IUDs were inserted: 164 A-Ievonorgestrel IUDs, 163 B-Ievonorgestrel IUDs, and 157 Nova-T IUDs. Every visit was recorded, and the data were sent to a central office. When more than 2 years had elapsed from the time of insertion, the results were analyzed by the life-table method of Potter8 with the use of a digital computer program. Group means of the number of days of bleeding were tested for two-sided significance by the t-test (IUD A versus the Nova-T, and IUD B versus the Nova-T). RESULTS Figures 1 and 2 show the age and parity distribution of the women. No significant differences % Levonorgestrel A D Levonorgestrel B Nova -T o II ~III Parity Figure 2 Parity distribution of patients in a randomized comparative performance study of two levonorgestrel IUDs and a Nova-T IUD. Fertility and Sterility

3 - Table 1. A Randomized Comparative Performance Study of Two Levonorgestrel IUDs and a Nova-T Copper IUD: The 24-Month Cumulative Event Rates per 100 Women Levonorgestrel Levonor- gestrel Nova-T A B Rates Accidental preg nancy Expulsiona Removal Medical Bleeding and/or painb Amenorrhea Hormonal c Infection Other Personal Planning preg nancy Other Continuation No. of first inser tions Woman-months of use apartial and complete expulsions. bheavy bleeding, intermenstrual spotting, pain, bleeding and pain. <Weight gain, acne, hirsutism, mental change. were recorded between the IUD groups. Table 1 shows the results of the life-table analysis at 24 months. The net cumulative pregnancy rates were 0.6 (A) and 0.0 (B) for the two levonorgestrel IUDs and 3.3 for the Nova-T at 24 months of use. The corresponding gross rates were 0.6 (A), 0.0 (B), and 3.7 (Nova-T). The Pearl indices at 24 months of use were 0.4 (A) and 0.0 (B) for the levonorgestrel IUDs and 2.0 for the Nova-T. The differences in pregnancy rates for the IUDs were not statistically significant. The net rates of removal because of bleeding and/or pain (including heavy bleeding, intermenstrual spotting, pain, and bleeding and pain) were below 8 for all three IUDs: 7.5 for A, 7.6 for B, and 7.1 for the Nova-T after 2 years of use. The differences were not significant. Figure 3 shows the monthly cumulative net rates of removal because of bleeding and/or pain. The monthly removal rate was lower for the Nova-T during the course of the study, but by 24 months all three IUDs were associated with the same net rate of removal. Figure 4 shows the monthly cumulative net rates of expulsion. Only one A levonorgestrel IUD was expelled during the 24 months of use. Five B Vol. 39, No.2, February 1983 levonorgestrel IUDs were expelled, all during the first 5 months of use, while a total of nine Nova Ts were expelled, the last of which was recorded at the 24-month follow-up visit. The net rates of expulsion were 0.6, 3.1, and 6.1 for the A and B levonorgestrel IUDs and the Nova-T, respectively. The differences were not significant. The 24-month net cumulative rates of removal because of amenorrhea were 10.7 for the A levonorgestrel IUD and 12.4 for the B levonorgestrel IUD, while there were no removals because of amenorrhea in the Nova-T group. The removal rates because of amenorrhea for the A levonorgestrel IUD (P < 0.01) and the B levonorgestrel IUD (P < 0.001) were significantly greater than that of the Nova-T device. Figure 5 shows the monthly net cumulative removal rates because of amenorrhea for both levonorgestrel IUDs. The removal rate was higher for the B levonorgestrel IUD, releasing greater amounts oflevonorgestrel, than it was for the A levonorgestrel IUD during all 24 months of use. There was a sharp rise in the removal rates for both IUDs at the 13th month of use, which time coincided with that of the I-year follow-up visit. Hormonal reasons for removal were weight gain, acne, hirsutism, or mental changes. There were no significant differences between the IUDs in the net rates of removal because of hormonal reasons. The rates were 6.7 and 4.1 for the A and B levonorgestrel IUDs, respectively, and 1.3 for the Nova-T. The highest removal rate for hormonal reasons was thus recorded for the levonorgestrel IUD with the lower release rate of levonorgestrel, and removals of the nonhormonal Nova-T device were also performed. There were no removals of either levonorgestrel IUD because of infection, and only one Nova T was removed for this reason (rate, 0.8). 20! ~ 10 Iii z! ~ o A-- B c MOnths Figure 3 Monthly cumulative net rates of removal because of bleeding and/or pain of two levonorgestrel IUDs (A and B) and a Nova T IUD (C). Nilsson et ai. Levonorgestrel IUD: 2 years' experience 189

4 A-- B C.-.-._._._ Ordinal month Figure 4 Monthly cumulative net rates of expulsion of two levonorgestrel IUDs (A and B) and a Nova-T (e). Removals because of other medical and other personal reasons were of the same order for all three IUDs. The continuation rates after 24 months of use were 66.6, 60.7, and 71.9 for the A and B levonorgestrel IUDs and the Nova-T, respectively. The differences in continuation rates between the three IUDs were not statistically significant. The numeric difference in continuation rate between the two levonorgestrel IUDs was due to the relatively great difference in removals because of planning pregnancy: 2.1 and 7.7 for the A and B levonorgestrel IUDs, respectively. The differences in continuation rates between the Nova-T and the two levonorgestrel IUDs were the result of the high removal rates due to amenorrhea associated with the levonorgestrel IUDs. Figure 6 shows the average number of days of bleeding during each of the first 24 months of use of the three IUDs. The days of bleeding were calculated from the records kept by every patient, and the average number of days of bleeding during the first postinsertion month was the same for all three devices. Already during the second month of use the number of days of bleeding was significantly lower with the A levonorgestrel IUD (P < 0.001) and the B levonorgestrel IUD (P < 0.02) than with the Nova-T. This difference lasted to the end of the second year of use. Table 2 shows the annual gross rates of events per 100 women. The pregnancy rate was 0 during both the first and second year of use of the B levonorgestrel IUD and 0.6 and 0, respectively, for the A levonorgestrel IUD. The corresponding figures for the Nova-T were 2.7 during the first year and 1.0 during the second year of use. No expulsions were recorded during the second year 190 Nilsson et al. LevonorgestrellUD: 2 years' experience of use of both levonorgestrel IUDs, and the rate of Nova-T expulsions decreased from 4.6 during the first year to 0.2 during the second year. Removal rates because of bleeding and/or pain were 5.6 and 5.8 for the A and B levonorgestrel IUDs, respectively, during the first year of use, and the rates decreased to 2.5 and 3.0 during the second year, while the rate increased from 2.6 during the first year to 5.4 during the second year with the use of the Nova-T. DISCUSSION Despite the improvements achieved in IUD performance with the new copper-medicated IUDs, bleeding and/or pain still remains the most common single cause for removal of an IUD. Improvements in patterns of bleeding have certainly occurred in association with the use of the copperreleasing IUDs, compared with the nonmedicated plastic IUDs. The life-table method of analysis of IUD performance, however, is not capable of discriminating between subgroups of reasons for removals because of disturbances of bleeding. In particular, the effect of alterations in the amount of blood loss during IUD use is not reflected by the figures reporting removals because of bleeding and/or pain by the life-table method. Rather, this method reflects irregular bleeding and bleeding episodes of abnormal length. The results of the present study show very low net cumulative removal rates because of bleeding and/or pain at 24 months of use. The rates for all three IUDs were below 8, which is markedly lower than corresponding figures reported in recent comparative studies. 4, 9, 10 The CuT-380A, CuT-200, and Nova-T have been associated with a net cumulative removal rate on the order of 15 to 20 because 20.! ~ 10 w z ~ i ~ o " A-- B ,.-_... f--'" Figure 5 Monthly cumulative net rates of removal because of amenorrhea of two levonorgestrel IUDs (A and B). B r Months Fertility and Sterility

5 ~ \ \ til C :s CD ~ d-ng-iud A d-ng-iud B Nova-T Figure 6 Average number of days of bleeding during each of the first 24 months of use of two levonorgestrel IUDs (A and B) and a Nova-T IUD., 15 months of bleeding and/or pain at 24 months of use.4, 11 The number of days of bleeding was highly significantly lower throughout the 2-year period in association with use of the levonorgestrel IUDs than with the Nova-T in the present study. However, the figures for removal because of bleeding and/or pain were equal for all three devices. Although these circumstances did not result in more favorable continuation rates for the levonorgestrel IUDs than for the Nova-T, they are healthpromoting by virtue of the decreased blood loss and by the higher hemoglobin concentrations in the peripheral blood of women using the levonorgestrel IUDs.12 In a population with poor nutritional conditions and a high frequency of anemia, this difference in the effect on the amount of menstrual blood loss associated with the use of levonorgestrel IUDs and copper-releasing IUDs becomes still more important. Locally administered levonorgestrel has a profound effect upon the endometrium, which becomes atrophic and inactive, with scarce glands and no mitotic activity.13 Because of this local effect, amenorrhea develops in a certain percentage of levonorgestrel IUD users. Ovulation, however, is not suppressed.14 Menstrual bleeding is restored within 1 month after removal of the levonorgestrel IUD,15 and recovery of fertility has been shown not to be affected by the use of a levonorgestrel IUD.16 Removals because of amenorrhea were performed at net rates of 10.7 (A levonorgestrel IUD) and 12.4 (B levonorgestrel IUD) after 24 months of use in the present study. The monthly cumulative net rate curve (Fig. 5) shows that most of the removals because of amenorrhea were performed at the time of the I-year follow-up visit, i.e., at the 13th month of use. The women, having been informed of the possibility of amenorrhea during use of the IUDs before entering the study, in very few cases personally requested removal because of amenorrhea. The removals were mainly performed as a result of the doctor's decision, and this in turn was due to the fact that no special policy was agreed upon with regard to the management of amenorrhea cases among the physicians participating in the study. If the rates of removal because of amenorrhea in the levonorgestrel IUD groups are omitted from the calculations as not being a negative side effect of IUD use, the net cumulative continuation rates at 2 years of IUD use rise to 77.3 and 73.1 for the A and B levonorgestrel IUDs, respectively, which is a very high continuation rate for any method of reversible contraception. The removal rates for hormonal reasons were equal for all three devices during the first year of use, when the women did not know which IUD they were using. The Nova-T was also removed for hormonal reasons. During the second year of use, the removal rates for hormonal reasons were Table 2. Annual Gross Rates of Events per 100 Women IUD A First year IUDB Pregnancy Expulsion Removal Bleeding and/or pain Amenorrhea Hormonal Other medical reasons Second year Nova-T IUD A IUDB Nova-T Vol. 39, No.2, February 1983 Nilsson et al. Levonorgestrel IUD: 2 years' experience 191

6 higher in association with the levonorgestrel IUDs than with the Nova-T, the women then knowing which IUD they were using. No infections were recorded during the 24- month use of either levonorgestrel IUD, and the infection rate was also very low with the use of the Nova-T. A total experience of over 20,000 woman-months of use of the levonorgestrel-releasing IUDs has been accumulated. Only three cases of pelvic inflammatory disease have been recorded thus far. 17 The overall experience and the data of the present study suggest that the use of a levonorgestrel-releasing IUD is not associated with an increased risk of pelvic infection and that there is a probability that a levonorgestrel IUD may in fact provide protection similar to that of oral contraceptives against infection,18 through its local hormonal mode of action. The levonorgestrel-releasing IUDs of the present study have an estimated lifetime of 7 years. The overall removal rates because of bleeding and/or pain during the first 2 years of use were extremely low; and, moreover, there was a decline in the rates of removal because of bleeding and/or pain during the 2nd year of use. Only one pregnancy occurred in association with the use of the A levonorgestrel IUD during the 1st year of use and none during the 2nd year, while no pregnancies occurred during the 2-year follow-up period in association with use of the B levonorgestrel IUD. The Pearl indices after 2 years of use were as low as 0.39 (A) and 0.00 (B) for the two levonorgestrel IUDs. Acknowledgment. This study would not have been possible without the valuable cooperation of the personnel of the participating countries. REFERENCES 1. Mishell DR Jr: The clinic factor in evaluating IUDs. In Analysis of Intrauterine Contraception, Edited by F Hefnawi, SJ Segal. Proceedings of the Third International Conference on Intrauterine Contraception, Cairo, Amsterdam, Elsevier-North Holland Publishing Co., 1975, p Nilsson CG, Luukkainen T, Diaz J, Allonen H: Intrauterine contraception with levonorgestrel: a comparative randomized clinical performance study. Lancet 1:557, Luukkainen T, Nilsson CG, Toivonen J: New methods for the regulation of female fertility. Proceedings ofthe Third World Congress of Human Reproduction, West Berlin, Amsterdam, Excerpta Medica, AHonen H, Luukkainen T, Nielsen N-C, Nygren K-G, Pyorala T: Two-year rates for Nova T and Copper T in a comparative study. Contraception 21:321, Nygren K-G, Nielsen N-C, Pyorala T, Allonen H, Luukkainen T: Intrauterine contraception with Nova-T and Copper-T 200 during three years. Contraception 24:529, Nilsson CG, Lahteenmaki P, Robertson DN, Luukkainen T: Plasma concentrations of levonorgestrel as a function of the release rate of levonorgestrel from medicated intrauterine devices. Acta Endocrinol (Copenh) 93:380, Luukkainen T, Nielsen N-C, Nygren K-G, Pyorala T, Kosonen A: Randomized comparison of clinical performance of two copper-releasing IUDs, Nova-T and copper-t-200. Contraception 19:1, Potter RG Jr: Application of life-table techniques to measurement of contraceptive effectiveness. Demography 3:297, Jain AK: Safety and effectiveness of intrauterine devices. Contraception 11:243, Tatum HJ: Comparative experience with newer models for the Copper T in the United States. In Analysis of Intrauterine Contraception, Edited by F Hefnawi, SJ Segal. Proceedings of the Third International Conference on Intrauterine Contraception, Cairo, Amsterdam, Elsevier-North Holland Publishing Co., 1975, p Sivin I, Tatum HJ: Four years of experience with the TCu 380A intrauterine contraceptive device. Fertil Steril 36:159, Nilsson CG: Comparative quantitation of menstrual blood loss with a d-norgestrel-releasing IUD and a Nova-T copper device. Contraception 15:379, Nilsson CG, Luukkainen T, Arko H: Endometrial morphology in women using a d-norgestrel-releasing intrauterine device. Fertil Steril 29:397, Nilsson CG, Lahteenmaki P, Luukkainen T: Levonorgestrel plasma concentrations and hormone profiles after insertion and after one year oftreatment with a levonorgestrel-iud. Contraception 21:225, Nilsson CG: A d-norgestrel-releasing IUD. Thesis, University of Helsinki, Nilsson CG: Fertility after discontinuation of levonorgestrel-releasing intrauterine devices. Contraception 25:273, Nilsson CG: Unpublished data 18. Ryden G, Fahraens L, Molin L, Ahman K: Do contraceptives influence the incidence of acute pelvic inflammatory disease in women with gonorrhea? Contraception 20:149, Nilsson et al. Levonorgestrel IUD: 2 years' experience Fertility and Sterility

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