Soledad Diaz

PROLONGED INTRAUTERINE CONTRACEPTION: A SEVEN-YEAR RANDOMIZED STUDY OF THE LEVONORGESTREL 20 mcg/DAY (LNg 20) AND THE COPPER T380 Ag IUDS

A levonorgestrel-releasing IUD and the Copper T 380Ag IUD were in randomized comparison for seven years in five clinics. In two other clinics the randomized study was truncated at five years, but use of the Copper T continued. No pregnancies occurred to users of either device in years 6 and 7. Cumulative pregnancy rates were 1.1 per 100 at seven years for the steroid-releasing and 1.4 per 100 for the copper-releasing IUDs. Cumulative rates of PID did not differ between devices. Infection rates appeared to be lowest during the sixth and seventh years of the study. Termination attributable to amenorrhea was the principal contributor to differences in cumulative continuation rates between devices. At the five clinics that carried the comparative study to seven years, cumulative continuation rates were 24.9 per 100 for LNg20 IUD users and 29.4 per 100 for TCu 380Ag users. Women who used either method for periods of five to seven years experienced, on average, marked to mild increases in hemoglobin as compared with levels at admission. The Copper T380 family and the LNg20 IUDs represent the most effective reversible contraceptive methods yet studied in long-term randomized trials.

Long-term contraception with the levonorgestrel 20 mcg/day (LNg 20) and the Copper T 380Ag intrauterine devices: A five-year randomized study

An intrauterine device, releasing approximately 20 micrograms/day of levonorgestrel (LNg 20), used by 1124 women, was studied in a randomized trial of five years duration in comparison with the Copper T, model TCu 380Agm in 1121 women. At five years, the gross cumulative pregnancy rate of 1.1 +/- 0.5 per 100 among users of the LNg 20 devices was not significantly different from the rate of 1.4 +/- 0.4 per 100 experienced by users of the Copper T 380Ag. The steroid-releasing IUD had significantly higher termination rates for expulsion and amenorrhea, a significantly lower termination rate for other menstrual problems and pain, and a lower continuation rate. The five-year continuation rate among women using the TCu 380Ag was 40.6 per 100 as compared with that of 33.0 per 100 among women randomized to the LNg 20 device (P less than .001). Terminations attributed to amenorrhea with the LNg device primarily account for differences in continuation. These two intrauterine devices are the most effective long-term, reversible IUDs yet reported in the literature. No other contraceptive methods have exhibited such low long-term pregnancy rates in randomized comparative trials.

A five-year clinical trial of levonorgestrel silastic implants (Norplant™)

Abstract Silastic implants containing the progestin, levonorgestrel, were tested as a long-term contraceptive system in 101 women. During five full years of use, no pregnancies occurred. The 5-year continuation rate was 54%. Menstrual irregularities were the most frequent reason for termination of use but only during the first year. More than half of the terminations for this reason were in the first year. Some of the subjects elected to continue use of the implants beyond 5 years, allowing release rate data to be obtained through 6 years. From the second through the sixth year of use, the implants delivered a constant 30 micrograms per day of levonorgestrel to the subjects, and even after six years 57% of the original steroid content remained in the capsules. Return of fertility following removal was essentially immediate and not related to time of use. Medical reasons for removal were infrequent and no pattern was discernible.

Fertility control in women with a progestogen released in microquantities from subcutaneous capsules.

Abstract Silastic capsules containing megestrol acetate (MA) were implanted subcutaneously in 97 women. Two dosages were studied. There were 160 woman-months of experience for the first group, which had 3 capsules and 595 for the second group, having 4 capsules. There were 5 pregnancies in the first and 4 in the second group. According to indirect signs, approximately 90 per cent of the cycles studied were ovulatory. It appears that the site(s) of action is peripheral to the ovary. Although abnormal bleeding did occur in approximately 30 per cent of the cycles, there were no serious complications associated with the method. The contraceptive effect of a silastic implant containing MA has been demonstrated for the first time in humans.

NORPLANT CONSENSUS STATEMENT AND BACKGROUND REVIEW

This review has highlighted the attributes of a very important new method of contraception. The signatories to this document agree that, with the provision of appropriate information and instruction for the user, Norplant is a good contraceptive choice to be made available worldwide in family planning programs that have the resources for appropriate training and counseling. The signatories to this document are acting in their own personal capacity and not as representatives of any particular organization.

A four-year clinical study of NORPLANT implants.

A total of 324 women aged 18-35 began use of NORPLANT subdermal implants in Finland Chile and the Dominican Republic in 1978-79. Through 4 years of 1st segment use the average annual continuation rate was 84/100 women and the 4 year cumulative rate was 49/100. There were no pregnancies in the 1st 2.5 years of use and a total of 2 by the end of 4 years. Single decrement (gross) pregnancy rate cumulated to 1.2/100 users at the end of month 48 and the Pearl index through 4 years was .2/100 woman years. Placement and removal of implants subject women to the risk of infection at the implant site. The use of implants as a practical method of family planning rests in part on the question of whether these relatively simple clinical procedures can be performed with a low infection rate under field conditions. Marked bleeding patterns were a concern. Some women experienced very long bleeding runs. With adequate training and supervision delivery and removal of implants can be done quickly and safely as indicated by the low infection rates (0.3/100 women). The training of personnel in the required skills is apparently no more difficult than was the training for the IUD 2 decades ago. Infection should it occur would tend to have less serious consequences for the woman than does pelvic infection. Perforation of the uterus in delivery of a copper IUD requires abdominal surgery to remove the device. No equally serious sequelae have been associated with improper placement or removal of implants.

Rates and outcomes of planned pregnancy after use of norplant capsules, norplant II rods, or levonorgestrel-releasing or copper TCu 380Ag intrauterine contraceptive devices

OBJECTIVES The objectives were to measure rates of planned pregnancy and factors affecting these rates after use of very-long-acting contraceptive methods (Norplant or Norplant II implants, a levonorgestrel-releasing intrauterine contraceptive device, or the copper T (model TCu 380Ag) intrauterine contraceptive device. STUDY DESIGN The design was a concurrent, multicenter prospective study of 372 women who stopped contraception for planned pregnancy. Analysis was by life-table, log-rank, and standard chi 2 methods. RESULTS Pregnancy rates 12 and 24 months after cessation of contraceptive use were 82 and 89 per 100, respectively. Age at removal and family planning intentions at initiation of contraception were both significantly correlated with pregnancy rates (p less than 0.05), but former contraceptive regimen and duration of contraceptive use were not. Pregnancy outcomes did not deviate from normal limits and did not differ by contraceptive formerly used. CONCLUSION Contraceptive implants releasing 30 micrograms/day of levonorgestrel or intrauterine contraceptive devices releasing 20 micrograms/day of levonorgestrel or having copper surface areas of 380 mm2 are associated with normal fertility after use for women seeking pregnancy at termination. Durations of use do not affect pregnancy rates.

Intrauterine contraception with copper and with levonorgestrel: A randomized study of the TCu 380Ag and levonorgestrel 20 mcg/day devices

First year results of a randomized study of 1509 users of the Copper T380Ag with a silver core or of an IUD releasing 20 mcg day of levonorgestrel are reported. The cumulative gross pregnancy rate for each device was 0.3 per 100 at one year, with more than 490 women having one year of use with each device. The levonorgestrel-releasing device was associated with significantly fewer bleeding days and significantly increased hemoglobin levels when compared with pre-admission values or the one year values observed among users of the TCu380Ag. Terminations attributable to amenorrhea were significantly more frequent among users of the levonorgestrel-releasing device. The TCu 380Ag was associated with increased frequency and severity of dysmenorrhea compared with pre-admission levels or with the steroid-releasing device. Hemoglobin levels were somewhat reduced among users of the TCu 380Ag device. Terminations attributable to pain were, however, not significantly different by device. Continuation rates at the end of the first year were not significantly different by device.

Recovery of fertility after use of the levonorgestrel 20 mcg/d or Copper T 380 Ag intrauterine device.

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.

Contraceptives for lactating women: A comparative trial of a progesterone-releasing vaginal ring and the Copper T 380A IUD

From approximately one week before normal ovulation resumes, lactating women require protection against pregnancy by a contraceptive that is safe for both infant and mother in a multicenter one-year study, the natural hormone, progesterone, delivered vaginally by a sequence of four contraceptive rings designed for continuous use, was evaluated as a contraceptive for nursing mothers in comparison with the Copper T 380A IUD. Individual rings release in effective average dose of 10 mg day for a 3 month period. Evaluation included measures of lactational performance as well as of contraceptive efficacy and safety to mother and child. Nine participating clinics enrolled 802 ring users and 734 IUD acceptors between postpartum days 29 and 63. Life table analyses were performed with parallel decrements for ring and IUD subjects. Continuation in the study and analysis required that subjects not stop breastfeeding. The ring, with a one-year pregnancy rate of 1.5 per 100, did not differ significantly from the IUD with respect to contraceptive effectiveness (p > 0.05). More than half of the ring subjects were continuing at 6 months post admission and a quarter (23.5 per hundred) were still using the ring and breastfeeding one year after admission. Women with the IUD, however, had higher continuation rates (p < 0.001) at both time points. The largest single decrement for each method was that for weaning. Ring users had more complaints of vaginal problems but had fewer vaginal disorders on examination. At 12 months postpartum, 46 per 100 continuing ring users remained in amenorrhea. Lactation performance and the health and weight gain of the infants were similar among users of either regimen.