Return to fertility after removal of a levonorgestrel-releasing intrauterine device and Nova-T. Long-term intracervical contraception with a levonorgestrel device. A 12-month comparative clinical investigation of a levonorgestrel-releasing intracervical device situated in the uterine cavity or cervical canal. A comparative clinical trial of Copper T 220 C and Alza T IPCS 52 intrauterine devices in Thai women. A collaborative study of the progesterone intrauterine device (Progestasert). The World Health Organization Task Force on Methods for the Regulation of Implantation. Microdose intrauterine levonorgestrel for contraception. World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction: Task Force on Intrauterine Devices for Fertility Regulation. Experience with two different medicated intrauterine devices: a comparative study of the Progestasert and Nova-T. A comparative study of the levonorgestrel-releasing intrauterine system Mirena versus the Copper T380A intrauterine device during lactation: breast-feeding performance, infant growth and infant development. Clinical performance of a levonorgestrel-releasing intrauterine system and oral contraceptives in young nulliparous women: a comparative study. Five years' experience with levonorgestrel-releasing IUDs. Puerperal insertion of a copper-releasing and a levonorgestrel-releasing intrauterine contraceptive device. Effect of a levonorgestrel intrauterine system on women with type 1 diabetes: a randomized trial. Randomized clinical trial with intrauterine devices (levonorgestrel intrauterine device (LNG), CuT 380Ag, CuT 220C and CuT 200B). A 36-month study. Indian Council of Medical Research Task Force on IUD. Comparison of the clinical performance, contraceptive efficacy and acceptability of levonorgestrel-releasing IUD and Norplant-2 implants in China. The effect of intrauterine devices, the stainless steel ring, the copper T220, and releasing levonorgestrel, on the bleeding profile and the morphological structure of the human endometrium--a comparative study of three IUDs. A morphometric study of 96 cases. The effect of low-dose 3-keto-desogestrel added to a copper-releasing intrauterine contraceptive device on menstrual blood loss: a double-blind, dose-finding, placebo-controlled study. Randomized comparison of levonorgestrel- and copper-releasing intrauterine systems immediately after abortion, with 5 years' follow-up. Comparative study of the progesterone t (65 microgram daily) and copper 7 iud. Comparison of T Cu 200 and Progestasert IUDs. Recovery of fertility after use of the levonorgestrel 20 mcg/d or Copper T 380 Ag intrauterine device. Comparison between two IUDs: Progestasert and CuT 200.
In a European randomized multicenter study, the efficacy and safety of an intrauterine contraceptive device releasing 20 microgram levonorgestrel/24 hours (LNG-IUD) have been evaluated and compared to the Nova-T. Because the LNG-IUD has a strongly suppressive effect on the endometrium and in some women affects ovarian function, the return to fertility after removal of the IUD was studied. Two-hundred-nine women (71 in the Nova-T and 138 in the LNG-IUD group), who had their IUDs removed because of planning pregnancy, were followed at least 24 months or until termination of pregnancy. For the Nova-T, the cumulative conception gross rate was 71.2/100 women after 12 months (79.7 after 24 months) and for the LNG-IUD 79.1 (86.6 after 24 months). The difference between the devices is not statistically significant, and in spite of the endometrial suppression during use of LNG-IUD, there is no delay of return to fertility and in both groups 96% of the pregnancies occurred during the first year after removal of the device. Eighty-four % of the pregnancies in the Nova-T group and eighty-six % in the LNG-IUD group ended in live births. The results suggest that the endometrium recovers quickly, normal ovulations are established and the fertility seems to be unaffected after use of an LNG-IUD. An intracervical levonorgestrel-releasing mini-T device was tried as contraceptive in 100 fertile multiparous women for 3 years. This device release about 10 micrograms/day. The results were compared with those of an intrauterine levonorgestrel device and copper-T-200 (Cu-T-200). The continuation rates of the three device did not reveal any significant differences at 1, 2 and 3 years. Incidence of unintended pregnancies and removals due to bleeding and pain was comparable to those of Cu-T-200 but higher than those of intrauterine levonorgestrel device. The number of days of bleeding and spotting for both levonorgestrel devices was significantly lower than those for Cu-T-200. A randomized study was performed in two clinics in order to compare the efficacy, safety and acceptability of a new model of a levonorgestrel-releasing intracervical device situated either in the cervical canal (group I) or in the uterine cavity (group II). Group I included 151 women (age 18-43) and group II, 147 women (age 19-43). The number of nulliparous women was 145. The total expulsion rate was 9.1%. The expulsion rate was lower among nulliparous women (4.8%) than among parous women (13.1%). There was also a significant difference in the expulsion rates between the two clinics. Two pregnancies occurred in both groups and two of these were ectopic, one in each group. The other two occurred after unnoticed expulsion. These figures give 12-month cumulative pregnancy rates of 1.3% and 1.4% in groups I and II, respectively. Total infection rate was 0.3%. The continuation rates were 82.1% in group I and 85.0% in group II after the first year. At three-month follow-up there were significantly fewer menstrual problems in group I than in group II (p = 0.0266). It is concluded that expulsion is still a problem with a small device but it may be diminished by intrauterine insertion and by selecting the users carefully. Two IUDs (Copper T 220 C and Alza T IPCS 52) were comparatively studied by randomized insertions in 200 Thai women who attended the Family Planning Clinic at the Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University. Point estimates of the pregnancy rate and rate of removal for bleeding and pain at 18 months were lower for the copper device than for the Alza T IPCS 52, but neither these nor any other pertinent event rates reached statistical significance. Study of the Alza device was halted before the completion of 2 years because reports from other centres indicated an unacceptable pregnancy rate beyond 2 years. A randomised double blind study of a plain T-shaped IUD and an active T-shaped IUD releasing 65 micrograms/day of progesterone, has been completed in four centres. A study of 1320 progesterone-releasing IUD's in parous women for 9660 women months of use significant to 18 months, gave a pregnancy rate of 1.0 +/- 0.4, expulsion of 4.7 +/- 0.6 and removals for pain and bleeding of 6.0 +/- 0.7. A detailed analysis of the menstrual bleeding patterns in these patients gave details of the number and length of bleeding and spotting episodes, count of bleeding days, and count of spotting episodes and days for four one-hundred-day reference periods. While the plain IUD contributed a significant number of intermenstrual spotting and bleeding days, the progesterone-releasing IUD contributed more spotting days. An intrauterine device (IUD) releasing 2 micrograms of levonorgestrel per 24 hours was compared in a randomized multicentre clinical trial with two copper IUDs-the TCu 220C and the Nova T. The 2 micrograms levonorgestrel device had statistically significantly higher pregnancy rates (from 390 days of use) and higher expulsion rates (up to 570 days). In addition, the total medical removals and removals for bleeding were significantly higher at all intervals where the data were analysed. Most disturbing was a 6.7 increased relative risk of ectopic pregnancy with the steroid-releasing IUD compared to the combined copper IUD data. It is concluded that the goal of microdose administration of 2 micrograms levonorgestrel to the uterine cavity does not achieve the objectives of a new and improved IUD device which is safe and effective. A comparative study of the Progestasert (UPS) and the Nova-T in 326 randomly selected women was carried out. The observation period was 1 year. The over-all continuation rates for the two types of intrauterine devices (IUDs) were similar. The expulsion rate for the Nova-T (9.2%) was considerably higher (P = 0.001) than that for the UPS (1.2%). Medical removals for bleeding/pain were more frequent (P = 0.028) for the UPS (15.4%) as compared with the Nova-T (6.1%). The pregnancy rate for the UPS (Pearl index = 4.8) was insignificantly higher than that for the Nova-T (Pearl index = 2.8). Two of the pregnancies in the UPS group were ectopic. No significant changes in the reactive immunoglobulins (IgA, IgG, or IgM) were observed in either of the groups. Our results indicate that neither of these two IUDs is preferable to the already existing medicated IUDs, such as the Copper T or the Copper 7. Mirena is a levonorgestrel-releasing intrauterine system (LNG-IUS) that provides highly effective and long-acting progestogen-only contraception.
                The objective of this study was to analyze the possible effects of using LNG-20 microg IUS on breast-feeding performance, infant growth and infant development during the first postpartum year as compared with the Copper T380A intrauterine device (Cu T380A IUD).
                This study is a prospective, controlled and randomized trial.
                The study was conducted at the Department of Obstetrics and Gynecology, Assiut University Hospital, Egypt.
                Three hundred twenty lactating women asking for initiation of contraception during the early postpartum stage were assigned randomly into two groups, the LNG-20 microg IUS group (n=163) and the Cu T380A group (n=157). The insertions were done 6-8 weeks postpartum. Each participant was followed up at three monthly intervals after insertion and until the first birthday of her baby. During these visits, the breast-feeding pattern was assessed, certain infant physical growth parameters were measured and a set of infant development tests was performed.
                No pregnancy occurred in both groups. There were no significant differences in the net continuation rates between the two groups (89.3 for LNG-IUS vs. 90.9 for Cu T380A). The LNG-20 microg IUS group had comparable rates of breast-feeding continuation, complete weaning, full breast-feeding and partial breast-feeding, with the Cu-IUD group. No statistically significant differences were found between groups with regard to all infant physical growth parameters and various infant development tests.
                The findings of the current study confirm that the use of LNG-20 microg IUS during the first postpartum year in lactating women provides highly effective and acceptable contraception and does not negatively influence breast-feeding or the growth and development of breast-fed infants. This 1-year randomized study was carried out at family-planning clinics of two university hospitals to compare the safety and acceptability of a levonorgestrel-releasing intrauterine system (LNG IUS) and oral contraceptives (OCs) in young nulliparous women. The study population consisted of 200 women aged 18-25 years seeking contraception. Ninety-four women entered the LNG IUS group and 99 entered the OC group. Continuation rates, reasons leading to discontinuation, adverse events, menstrual questionnaires, subjective well-being and sexual behavior were evaluated. Nineteen women (20%) in the LNG IUS group discontinued the study during the 1-year observation period, and 27 discontinued (27%) in the OC group. The most common reason (31%) for discontinuation in the IUS group was pain. In the OC group, hormonal side effects were the predominant medical reason for study termination. The safety and acceptability of the LNG IUS for contraception was observed to be as good as with OCs, with a high continuation rate. Two levonorgestrel-releasing IUDs and a copper-releasing IUD of the same shape were studied in a randomized comparative study over five years. The levonorgestrel-releasing IUDs released 20 micrograms or 30 micrograms per day. The Pearl index during the 10,600 woman-months of LNG-IUD use was 0.11. The control device releasing copper had a Pearl index of 1.6. The amount and duration of menstrual bleeding was greatly reduced, leading to a high incidence of oligo- or amenorrhea. The continuation rate in this pioneer trial was 53 per 100 users for the levonorgestrel-releasing IUD (LNG-IUDs) and 50 per 100 users for the copper-releasing IUD (Nova T). The removal rates for reasons other than amenorrhea were not significantly different. Discontinuation because of amenorrhea occurred during the first two years, the cumulative termination rate for this reason was 11.6 per 100 users at five years. The LNG-IUDs removed for investigation after five years of use revealed that the devices contained about 40 percent of the original load. The effective lifespan of the device has been demonstrated by this study to be five years; the residual steroid gives an additional safety period of two more years. The LNG-IUD is a highly effective reversible contraceptive method, which strongly reduced the amount and duration of bleeding. During the first two months there is scanty but frequent spotting which, like the high incidence of oligo- and/or amenorrhea, requires counselling of health personnel and women using LNG-IUDs. A copper-releasing IUD and levonorgestrel-releasing IUDs releasing 30 micrograms and 10 micrograms levonorgestrel per day were inserted six weeks after delivery in 110 volunteers. During the treatment, events and patterns of bleeding were recorded and plasma levonorgestrel concentrations were measured. The number of events in one year of follow-up was very low, four removals out of 40 in the copper-releasing IUD group and five removals out of 70 in the levonorgestrel-releasing IUD group. Bleeding and spotting was significantly more common after insertion of a levonorgestrel-releasing IUD than a copper-releasing IUD, but it was scanty and well-tolerated. After three months, levonorgestrel-releasing IUD patients had less bleeding and spotting than the copper-releasing IUD patients. No pregnancies occurred during the study period. There were two uterine perforations with a uterine sound at the insertion. In the 30-micrograms per day levonorgestrel-releasing IUD group, initially high plasma levonorgestrel concentrations reached a plateau four weeks after the insertion. In the 10-micrograms per day levonorgestrel-releasing IUD group, the plasma concentrations of levonorgestrel stabilized after the initial two weeks. Women with diabetes need safe, effective contraception. Although intrauterine devices provide superior contraception, concerns remain that progestin absorbed systemically from the levonorgestrel-releasing device may impair carbohydrate metabolism. To examine the effect of the levonorgestrel-releasing intrauterine system on glucose metabolism in diabetic women.
                We randomly assigned 62 women with uncomplicated insulin-dependent diabetes mellitus to either a levonorgestrel-releasing or a copper T 380A intrauterine device. The primary outcome to assess glucose metabolism was glycosylated hemoglobin; fasting serum-glucose levels and daily insulin dose requirements over 12 months of observation were examined as well.
                Outcome data were available for 29 women using the levonorgestrel-releasing and 30 using the copper device. At 12 months, mean glycosylated levels were similar for women of the 2 groups (6.3%, standard deviation [SD] +/- 1.5 compared with 6.3%, SD +/- 1.3, respectively). The same was true for mean fasting-serum glucose levels (7.4 mM, SD +/- 4.2 compared with 7.5 mM, SD +/- 4.2) and daily insulin doses (35.1 units, SD +/- 12.8 compared with 36.4 units, SD +/- 9.0). No important differences were noted at either 6 weeks or 6 months.
                The levonorgestrel-releasing device had no adverse effect on glucose metabolism, even at the 6-week observation when systemic levels of levonorgestrel would have been higher than at later observations. Concern about a potential adverse effect of this contraceptive on glucose control is unwarranted, and its use in women with diabetes should be liberalized.
                I. A total of 1905 subjects were randomly allocated to four types of intrauterine devices (IUDs) and were observed for 45,683 woman-months of use. While no method failure was observed with levonorgestrel (LNG) IUD, 11 women became pregnant with other devices; 4 with Copper T 380Ag, 1 with Copper T 220C, and 6 while using Copper T 200B, indicating method failure rates of 1.0, 0.3 and 1.6, respectively, at 36 months of use. These rates were within acceptable range. Continuation rates were significantly lower with LNG IUD (74.5, 58.7, 38.8 at 1 year, 2 years and 3 years, respectively) as compared to other copper devices, which ranged between 82.4 to 84.4 at 1 year, 66.6 to 69.9 at 2 years and 45.4 to 50.4 at 3 years. The difference in continuation rates was mainly due to menstrual disturbances (e.g. amenorrhoea, irregular bleeding) which were higher with LNG IUD (27.9 per 100 users) as compared to the copper devices (13.4-15.4 per 100 users) at 36 months of use. The risk of expulsion ranged between 8.3 to 10.6 per 100 users and was comparable for all the devices. The observations from the present study based on 36 months of experience with different intrauterine devices do not indicate the need to replace CuT 200, the device currently in use in the National Programme. The levonorgestrel-releasing IUD (LNG-IUD, 20 micrograms/d) and the Norplant-2 implants were studied in a randomized comparative clinical trial with 200 women for one year. No pregnancy or expulsion occurred with the Norplant-2. In the LNG-IUD group, there was one pregnancy at the 12th month of use after an unnoticed expulsion. The net cumulative pregnancy and expulsion rates of LNG-IUD were 1.0 and 3.0. The removal rate due to menstrual disturbances in both LNG-IUD and Norplant-2 groups was 3.0. The use-related discontinuation rates were 9.0 and 3.0, and the continuation rates were 90.0 and 96.0, respectively. The differences were not statistically significant. Menstrual disturbance was the main side effect. It was improved after long time use, especially in the LNG-IUD group. After one year, the percentages of women with amenorrhea were 18.9 for the LNG-IUD and 8.3 for the Norplant-2. The menstrual blood loss was statistically significantly reduced in the LNG-IUD group, and blood haemoglobin concentration increased in both groups. The LNG-IUD and Norplant-2 are highly effective, safe, long-acting, and well accepted by the Chinese women. Thirty-four women using the stainless steel ring (SS), 43 women using the Copper T220 (TCu), and 19 women using levonorgestrel-releasing intrauterine devices (LNG) were admitted to the study. The light microscopic biopsy material was subjected to morphometric studies including 8 indices of endometrial activity before (Control) and after 24 months of exposure to the SS and TCu device and 3-10 months of exposure to the LNG device. The women were grouped into subjects with and without intermenstrual and prolonged bleeding. The results revealed that there were highly significant differences between the IUDs at the endometrial level as displayed by morphometry. However, the difference between bleeders and non-bleeders was not significant in any of the three types of IUDs. Although the mode of action of these IUDs at the endometrial level is different, the mechanism responsible for the irregular endometrial bleeding needs to be further investigated. We sought to establish the lowest dose of 3-keto-desogestrel, when added to a copper-releasing intrauterine contraceptive device, that is needed to reduce menstrual blood loss to a very low level and to treat (essential) menorrhagia successfully.
                A double-blind group comparative study was designed in which 203 healthy women with or without menorrhagia were enrolled and randomized to four different Multiload Cu250 intrauterine contraceptive devices, releasing 0 (control), 1.5, 3, or 6 microg of 3-keto-desogestrel daily. Menstrual blood loss, hemoglobin, and serum ferritin levels were determined before and during treatment.
                All 3-keto-desogestrel-copper intrauterine contraceptive devices reduced menstrual blood loss significantly, causing a reduction of up to 30 to 40 mL after 12 months of use. All women with essential menorrhagia were considered to have been successfully treated after 6 months of use. Serum ferritin levels rose with all three 3-keto-desogestrel-loaded devices.
                A Multiload Cu250 intrauterine contraceptive device releasing 1.5 microg of 3-keto-desogestrel daily is able to reduce menstrual blood loss to a very low level and to replete body iron stores in women with or without menorrhagia. Higher doses have no superior effect. Women who seek an abortion are motivated to use contraceptive methods afterwards. Because the return of fertility after abortion is immediate, there is a need for effective and safe contraception promptly after the termination of pregnancy. A randomized trial of Mirena and NovaT intrauterine contraceptive devices inserted at the time of elective termination of pregnancy, duration no more than 12 weeks, is reported here. Women were randomized 2:1 resulting in 305 subjects with Mirena and 133 with NovaT as a segment of a larger study of 3000 women. In the Mirena group, two pregnancies at year 4 resulted in a final gross rate of 0.8 at 5 years, which was significantly (p < 0.0004) lower than the corresponding rate of 9.5 with NovaT. Terminations because of expulsion, bleeding problems, pain, pelvic inflammatory disease and other medical reasons were less common in the Mirena group, but not significantly different. The cumulative expulsion gross rate for NovaT at 5 years was 15.4 and for Mirena it was 10.5. Termination rates because of amenorrhea were low in both groups. It is concluded that both devices were well tolerated. Mirena was more effective and the rate of adverse events was lower than with NovaT. Special attention should be paid to the insertion procedure when carried out at the time of abortion. nan Insertions of the T Cu 200 and the Progestasert IUDs in a total of 400 postpartum women were compared. Insertions were carried out within 10 minutes of delivery, either manually or with an inserter. There was a significant difference in the 6 and 12 month expulsion rates (P0.05) between the 2 groups, but no differences were found related to type of insertion. 12 month expulsion rates for the T Cu hand and inserter groups were 9.0 and 8.1, respectively, and 35.8 and 35.2 for the Progestasert hand and inserted groups, respectively. Overall, significantly fewer Progestasert users reported dysmenorrhea at follow-up and the specific 12 month dysmenorrhea rate was significantly lower for the Progestasert users than for the T Cu users. More women in the Progestasert groups reported intermenstrual spotting and bleeding, but specific 12 month rates of intermenstrual pain, spotting, and bleeding showed no differences between the groups. Following use of either the Levonorgestrel 20 mcg/day or the TCu 380 Ag IUD in a randomized comparative study, 110 women stopped contracepting to have planned pregnancies. Pregnancy rates and recovery of fertility have been assessed. Age at acceptance, duration of use, parity and intervals between last pregnancy and IUD insertion or removal were similar for both groups. Life table pregnancy rates at one year were higher than 90 per cent for both device groups; but because some women quickly changed their minds or had been at risk of pregnancy only a short time before the analysis date, only 60.9 percent had actually become pregnant. Median time to planned pregnancy was 3 months for the TCu 380 Ag group and 4 months for the Levonorgestrel 20 group. Neither duration of use nor age at insertion or age at termination affected the pregnancy rates significantly. nan
Evidence suggests there is no difference in pregnancy rates among LNG-20 IUS, IUD >250mm2 and Norplant-2 users. The LNG-20 IUS more effectively prevented intrauterine and extrauterine pregnancies than IUDs ≤250mm2. P4-IUS was significantly more effective than non-medicated IUDs, but no difference was observed when compared to IUDs ≤250mm2. Continuation rates for LNG-20 IUS, non-hormonal IUDs and Norplant-2 were similar. Lack of menstrual bleeding was the main reason for discontinuation of LNG-20 IUS.
Recent evidence, from studies meeting the review inclusion criteria for the update conducted in July 2009, suggests that the LNG-20 IUS does not impact upon breastfeeding performance or the growth and development of breastfed infants in lactating women nor did the device have an adverse effect on glucose metabolism among insulin-dependent diabetic women.