Effects of long-acting contraceptives on mammary glands of patients with diffuse fibrocystic mastopathy were under study. A total of 206 women aged 17 to 38 were examined. In 50 of them fibrocystic mastopathy was detected by palpation, non-contrast mammography, and ultrasonic examination. On days 5-7 of the cycle the patients were injected 1 ml of depot provera or noristerate or subcutaneously implanted norplant. Injections of the two former agents were repeated in 3 months if necessary. Control examinations were carried out 3 months to 5 years after the contraceptives were started. The results indicate that long-acting contraceptives did not cause any negative changes in the course of mastopathy in 32 of 50 women. In 18 women the general status improved (pain and induration in the mammary glands disappeared), mammographic, thermographic, and ultrasonic data improved, this prompting us to continue our research.

The future of treatment-including addiction treatment-is biotechnological. Depot injections, agonist/antagonist implants, deep brain stimulation, and hapten conjugate vaccines are hailed by researchers and pharmaceutical manufacturers as medicine's best hope to minimize illicit use, to decrease risk of overdose and painful withdrawal, and to prevent diversion of medicines to illicit markets. Marketing and use of new technologies reveal old tensions framing concepts of addiction and its treatment: between medical condition and disorder of the will, between criminal justice and health, and between patient choice and system control. Using the examples of depot naltrexone and implantable and injectable buprenorphine in the U.S., this essay considers the arc of long-acting opioid treatment and implications for the future. These include the rise of Vivitrol courts and "carceral prescription"-where criminal justice systems mandate medicine to lock up brain receptors much as they might lock up people themselves-as well as use of buprenorphine formulations positioned as increasing both patient benefit and provider control. We also consider lessons from debates on long-acting contraceptive technologies such as Norplant and Depo-Provera. While multiple new long-acting formulations are under development, success will be determined less by characteristics of particular formulations and more by whether or not the new technologies are accompanied by a new ethics of addiction treatment that emphasizes therapeutic alliance, concordance over compliance, and a genuine commitment to allowing patients the ability to narrate and be believed in their descriptions of their treatment experiences.

Keywords: Buprenorphine; Implants; Long-acting treatment; Naltrexone; Opioid addiction treatment.

Changes in serum nickel, copper and zinc were evaluated in 45 Norplant users. Two groups were selected for this study. Group I included 15 regularly menstruating females as controls and as short-term users (90 days after Norplant insertion). Group II included 30 Norplant users for one year or more as long-term users. These elements were determined by atomic absorption spectrophotometry. Serum nickel showed no significant change in short-term nor in long-term users when compared to the control group or to each other. Serum copper and zinc revealed a significant increase in short-term users for a short period of time, which returned to normal levels in long-term users. There was disappearance of the cyclic changes in serum copper and zinc concentrations on comparing their levels in ovulatory to non-ovulatory Norplant users. The use of Norplant has no deleterious effects on serum levels of nickel, copper and zinc.

Substantial improvements have been made in oral contraceptives, a new injectable contraceptive (Norplant), and the intrauterine device (IUD). Major risks with oral contraceptives have declined substantially, and a number of noncontraceptive health benefits have been discovered. Norplant is probably the first new contraceptive in recent years, and offers long-term contraception with high efficacy and modest risks. The IUD, by carefully selecting users, is a safe and efficacious contraceptive method. The major risk, pelvic inflammatory disease (PID), is far less common if one avoids use in the presence of risk factors for PID.

OBJECTIVE

In the months following FDA approval of Norplant, discussions of the controversies surrounding its introduction took place largely in newspaper and magazine articles detailing interviews with legal and health professionals and scientists who developed the device. This qualitative study brings the viewpoints of selected groups of consumers, reproductive health care workers, and local policy makers to the public discussions of Norplant. This article explores one of several themes raised by study participants--Norplant use by adolescents.

METHODS

Eighteen different focused group interviews were conducted in California between November 1991 and November 1992. A total of 146 individuals attended--63 consumers, 44 health care providers, and 39 policy makers. Participants included consumers identified as so-called "targets" of Norplant use, individuals providing reproductive health services, and individuals in policy and decision-making roles.

RESULTS

Participants in all the focus groups agreed that Norplant should not be used to accomplish social goals or viewed as the answer to society's pressing social and economic problems. There was no agreement, however, on the issue of Norplant use by adolescents. Study participants argued persuasively on both sides of the question, expressing ambivalence concerning the incidence of teenage pregnancies, the longterm health effects of Norplant use on adolescents, and the threat of increased risk of STDs and HIV/AIDS among adolescents using Norplant.

CONCLUSIONS

Study findings highlight a critical need for ongoing dialogue among key stakeholder groups to develop an understanding of the diverse values informing the debate. Participants' responses reinforced that decision-making in public health need not only be the jurisdiction of policy makers, elected officials, and others. Ordinary citizens can be part of the task as well by offering insights for practical and ethical solutions to some of our most pressing social issues.

Contraceptive prevalence in Mauritius (76%) is among the highest in the world. Yet, it is estimated that each year there are some 20,000 cases of induced abortion, which is illegal in the country. A study based on a sample of 475 women admitted to three hospitals with complications due to induced abortion revealed considerable use of unreliable methods (e.g., withdrawal and natural methods), frequent method switching, and inconsistent use of modern methods. The study also found that women seeking abortion were usually under 30 years of age, and 20% of women with abortion complications were not using any method, and some 50% were using an unreliable method at the time they became pregnant. It emerged that with increasing numbers of women employed, their work schedules hindered their going to a family planning clinic and resulted in abortion being used as a back-up to contraception failure. Among the women with abortion complications, 25% had already had a previous abortion. These findings came as a big surprise to the family planning services. To discuss the findings, a national symposium was held in July, 1993. The symposium was attended by government ministers, members of parliament, and international personalities in the field of family planning. A discussion of the results of the study also took place in the National Assembly, where a motion was tabled to decriminalize abortion. The findings also facilitated, albeit indirectly, the approval of Norplant in the country.

A longitudinal study was undertaken to assess PRL, cortisol, TSH, T3 and T4 levels in NORPLANT implant users (n = 22) and Copper T users (n = 20). Participants were healthy women with no contraindication for hormonal contraception. Samples were drawn at 0930 to 1000 h twice pretreatment and at month 2, 4, 6, 12, 24 and 36 after insertion. At the second treatment month, a second sample was obtained at 1600 h to assess cortisol diurnal variation. Hormones were measured by RIA. Values for all hormones were similar in Norplant and Copper T users. No significant changes occurred throughout the study period. Elevated PRL levels (greater than 500 mU/1) were found in three women from each group before and during treatment but no clinical evidence of hyperprolactinemia was detected. The results of this study reassure that long-term use of NORPLANT implants do not impair plasma levels of cortisol, prolactin and thyroid hormones.

Norplant is an effective, long-acting, reversible, progestin-only contraceptive that provides protection for up to five years. The aim of this review is to ascertain the response of family planning clients in Zaria to Norplant. In Nigeria, Family Health International started pre-introductory clinical research on Norplant in 1985 at five sites including Zaria. Since the conclusion of the study, Norplant services have been maintained, but no attempt has been made to report the response of this largely Hausa and Muslim community where contraceptive use is generally low. It is important to determine whether the advantages of Norplant have had an impact on this setting. The study showed that most of the clients were satisfied with the method. There was a progressive increase in the number of women using Norplant by 1995, with a significant decrease in the number of women undergoing sterilisation. Acceptability of Norplant is on the increase, thus, it should be easily available, accessible and affordable.

Silastic implants containing the progestin, levonorgestrel, were tested as a long-term contraceptive system in 124 women. During five years of use no accidental pregnancy occurred. The first year continuation rate was 90% and the five-year continuation rate was 54%, including terminations for wish to become pregnant. The medically relevant continuation rate was 68% after five years. Menstrual irregularities were the most frequent reason for termination, but only in the first two years. 70% of the terminations for that reason occurred during the first two years. Terminations for other steroid-related reasons were infrequent. The follow-up will continue up to the end of the seventh year. Seven of seventeen women who requested removal of the implants because they wanted to become pregnant conceived during the first two cycles and only three were not pregnant one year after removal.

Adolescent pregnancy rates have declined modestly, most likely because of the increased use of condoms, especially at first intercourse. Condom distribution in schools appears to be effective in promoting condom use without increasing sexual activity. Although, to date, no contraceptive has been as effective as Norplant in reducing teen pregnancy, use of the method has declined dramatically. Depo-Provera use is increasing, but continuation rates are disappointing and the impact on teen pregnancy rates is as yet unknown. Emergency contraception remains underutilized, and interventions to improve oral contraceptive compliance are beginning to be explored. School-based programs that provide contraception without adding a strong educational component fail to improve contraceptive use or reduce pregnancy rates. Use of any contraceptive by teens is cost effective.

Two methods for release of levonorgestrel from polydimethylsiloxane (Silastic) subdermal implants for contraception were studied. The first system consists of six 3 cm long Silastic capsules filled with levonorgestrel (NORPLANT). The second one consists of two 4 cm long rods made from Silastic and levonorgestrel, covered with thin Silastic tubing (NORPLANT-2). The contraceptive efficacy of NORPLANT implants was excellent during the four years of observation. That of NORPLANT-2 implants was very good during the first three years, but not acceptable during the fourth year. Both types of implants were well tolerated and the most common side effect experienced was bleeding disturbances such as irregular bleeding and periods of prolonged bleeding. The frequency of such disturbances decreased considerably after the first year of use. The plasma levels of levonorgestrel decreased throughout the study, and did not show any statistically significant difference between users of the two types of implants. The plasma levels of levonorgestrel in women who became pregnant did not differ from those in women who did not become pregnant. Levonorgestrel binds to sex hormone binding globulin (SHBG) with high affinity, and in the bound form is not biologically active. A "free levonorgestrel index" (FLI), i.e. the ratio of plasma level of levonorgestrel to SHBG capacity, was calculated. Women with NORPLANT had higher FLI than those with NORPLANT-2 and women who became pregnant had lower FLI than those who did not. It is suggested that NORPLANT-2 implants have a lower rate of release of levonorgestrel than NORPLANT implants. SHBG capacity, thyroid binding proteins and corticosteroid binding globulin decreased during treatment. Plasma total testosterone decreased during treatment, whereas free testosterone was unaltered. Thyroid function and plasma cortisol levels did not change during treatment. Treatment with phenytoin decreased the contraceptive effect. In a group of regularly menstruating women who had used NORPLANT-2 implants for more than three years, 40% showed anovulation, 20% luteinization of unruptured follicles and 40% apparent ovulation.

This is a cross-sectional study involving 364 clients who have had Norplant implants insertion for contraception at the Gandhi Memorial Hospital (GMH) during the second half of 1994. It was part of the pilot project designed to introduce Norplant in Ethiopia after evaluating the safety, efficacy, tolerance, acceptability and reversibility of the method. The vast majority of the clients were found to be married, housewives, multiparae, relatively educated, urban dwellers, Christian by faith and in their reproductive age group with a mean age of 27.9 +/- 5.7 years. A significant number of them used one or more types of contraceptive methods prior to their switch to Norplant (P < 0.05). A third of the patients were lactating at the time of the Norplant insertion. The time taken to insert the implants was 12.5 +/- 4.3 minutes. The mean duration since the insertion is computed to be 25.3 +/- 4.2 months. Their main source of information was from the medical personnel. The acceptability and continuation rate of the method was 93.9% and 95.1%, respectively. The fertility-reversibility among those who desired to have childbirth was achieved in 72.3% and 84.1% at one and two years, respectively. Adverse effects of Norplant were registered in a quarter of the study population and included abnormal menstruation, headache, weight changes and pain at the site of implantation. These were not influenced by age, body weight, parity, duration of usage of the method, blood pressure patterns and previous use of contraception (P>> 0.05). We have not encountered any method failure in the last 30 months. The study concludes that Norplant is safe, effective, acceptable, and reversible long-term birth control method which can be used in our setting in parallel with other available options.

The case notes of 377 clients who accepted Norplant out of 11961 acceptors of family planning methods in the Department of Obstetrics and Gynaecology University of Benin Teaching Hospital, between January 1985 and December 1996 were retrieved and analysed at the end of 2004, for socio-demographic characteristics of the clients, side effects and complications reported and reasons for discontinuation in relation to duration of use. The daily register of the acceptors were analysed for new acceptors of other methods during the same period and confirmed with their case notes. The acceptance incidence of Norplant was 3.2%. The mean age and parity of the acceptors were 32.2 +/- 4.5 years and 3.9 +/- 1.8 respectively. The duration of use ranged between 6 months and 13 years. 65% of the acceptors reported menstrual abnormalities. 48% of them reported reduced bleeding pattern, while 7.5% (25) discontinued method under 4 years of use because of increased bleeding episodes. Other side effects reported were headache 6%, weight gain 3%, mastalgia 1.8%, decreased libido 1.8%, abdominal pain 1.5% and hypertension 1.2%. 20.4% (68) discontinued the use under 4 years because of desire to have another baby. 38.6% (129) had implants removed at 5 years, while 20.1% (67) continued the use for 6-13 years before removal and replacement with another set. Husband's request for removal constituted 7.2% (24). The effectiveness was 100% as no pregnancy was reported during the study period. The continuation rate at 5 years was 58.7%. 43 clients were however lost to follow up. Norplant was found to be an effective and acceptable method of long-term reversible contraception with minimal side effects. The low incidence was attributed to the fact that the implants were donor driven and not included in the country contraceptive logistic system. Norplant acceptors who continued the use after 5 years did so, because they enjoyed it and did not want to part with them without replacement of new sets.

It is a prospective study based on the pre introduction evaluation of Norplant implants conducted from September 92 to September 93 in the city of Ouagadougou. 197 women were selected for the study. Based on unemployed women with an average age of 31 years old. The average parity was of 5.47% of patients were multiparas. A gain of weight of an average of 2.43 kg was observed. The main side effects observed was cycle disorders and headache. The continuing rate after 12 months was 96.5%. Conclusion from this study is that Norplant Implants are well tolerated and accepted by women.

This paper presents findings based on a one-year pre-introductory clinical investigation concerning safety, efficacy, and acceptability of the new contraceptive NORPLANT implants in Sri Lanka. The study is based on 400 acceptors of the implants at two clinics in Sri Lanka. Acceptors' mean age was 27 years, mean number of children was about two, and average educational attainment was eight years. Nearly half of the acceptors did not want to have another child. Follow-up was conducted at one, three, six, and twelve months. The one-year termination rate due to medical problems was very low, and the one-year life-table pregnancy rate was 0.5. Menstrual pattern disruption was the most frequently reported complaint with the implants. Amenorrhea increased in the first three months of use, and intermenstrual bleeding was common among those menstruating. In spite of these changes and some significant variations between the acceptors in the two study center, the overall degree of satisfaction with the implants was very high. The features most important to the acceptability of the implants were low risk of pregnancy, the long duration of action, and the convenience of use. The results of the study suggest that NORPLANT implants are safe, effective, and highly acceptable to Sri Lankan women.

OBJECTIVE

This study was conducted to determine sociodemographic characteristics and usage interval according to insertion period, observed side effects and reasons for discontinuation in 756 cases where Norplant was inserted and removed for any reasons at our hospital since 1994.

METHODS

Seven-hundred and fifty-six cases in whom Norplant was inserted and removed since 1994 were included in our study. Sociodemographic characteristics, former contraception method, reasons for choosing this method and side effects seen during the usage period were determined. In all cases, reasons for discontinuation, sociodemographic characteristics and usage interval according to the insertion period were investigated. Statistical analysis of this study was performed with SPSS 9.0 (analysis of variance).

RESULTS

Mean age of cases was 26.5 +/- 4.9 years, mean number of living children was 2.0 +/- 1.2, and 50.4% of cases had no health insurance. Most of the cases used coitus interruptus previously as a contraceptive method and chose Norplant use because of its effectiveness. Insertion periods were as follows: interval, n = 513 (67.9%); postpartum, n = 127 (16.8%) and postabortion, n = 116 (15.3%). Various side effects were detected in 79.8% of the cases. Bleeding problems were seen in 69.8%. Pregnancy occurred in only one case. Mean Norplant usage interval was 3.08 +/- 1.68 years. The longer usage interval was seen in cases with lower educational level. When we compared the usage intervals between interval, postpartum and postabortion periods, we found that the interval group had a shorter mean duration of Norplant use. Discontinuation because of bleeding problems occurred in 38.1%. Removal of all Norplant implants was performed at a single session in 731 cases (96.4%). After Norplant removal, most cases selected either condom or IUD as the contraceptive method.

CONCLUSIONS

It is concluded that despite the frequent occurrence of side effects, Norplant is a modern, long-acting, highly effective, reversible, easy-to-use, satisfactory form of birth control, especially in selected cases.

OBJECTIVE

To assess the contraceptive efficacy, tolerability and acceptability of hormonally impregnated intrauterine systems (IUSs) in comparison to other reversible contraceptive methods.

METHODS

Literature was identified through database searches, reference lists and individuals/organisations working in the field.

METHODS

All randomised controlled trials comparing IUSs with other forms of reversible contraceptives and reporting on pre-determined outcomes in women of reproductive years. The primary outcomes were pregnancy due to method/user failure and continuation rate.

METHODS

The quality assessment of studies and data extraction were completed independently by two blinded reviewers. A quality checklist was designed to identify general methodological and contraceptive specific factors which could bias results. Events per women months and single decrement life table rates were extracted where possible for pregnancy, continuation, adverse events and reasons for discontinuation. Events per total number of women at follow up were collected for hormonal side effects and menstrual disturbance. When appropriate, data were pooled at the same points of follow up to calculate rate ratios in order to determine the relative effectiveness of one method compared to another. For the single decrement life table rates, the rate differences were pooled to determine the absolute difference in effectiveness of one method compared to another. Interventions were only combined if the contraceptive methods were similar. Non-hormonal IUDs were divided into three categories for the purpose of comparison with IUSs: IUDs >250mm2 (i.e. CuT 380A IUD and CuT 380 Ag IUD), IUDs <=250mm2 (i.e. Nova-T, Multiload, CuT 200 and CuT 220 IUDs) and non-medicated IUDs.

RESULTS

Nineteen RCTs comparing hormonally impregnated IUSs to a reversible contraceptive method met the inclusion criteria and it was possible to include eight of these in the meta-analyses, four comparing LNG-20 IUSs with non-hormonal IUDs, one comparing the LNG-20 IUS with Norplant-2 and three comparing Progestasert with non-hormonal IUDs. No significant difference was observed between the pregnancy rates for the LNG-20 users and those for the IUD >250mm2 users. However, women using the LNG-20 IUS were significantly less likely to become pregnant than those using the IUD <=250mm2. Women using the LNG-20 IUS were more likely to experience amenorrhoea and device expulsion than women using IUDs >250mm2. LNG-20 users were significantly more likely than all the IUD users to discontinue because of hormonal side effects and menstrual disturbance, which on further breakdown of the data was due to amenorrhoea. When the LNG-20 IUS was compared to Norplant-2, the LNG-20 users were significantly more likely to experience amenorrhoea and oligomenorrhoea, but significantly less likely to experience prolonged bleeding and spotting. No other significant differences were observed. Progestasert users were significantly less likely to become pregnant and less likely to continue on the method than non-medicated IUD users after one year, but no significant differences was noted for these two outcomes when Progestasert users were compared to IUD<=250mm2 users. The only other significant differences found in the meta-analyses were that Progestasert users were less likely to expel the device and more likely to discontinue the method because of menstrual bleeding and pain than users of IUDs <=250mm2.

CONCLUSIONS

Current evidence suggests LNG-20 IUS users are no more or less likely to have unwanted pregnancies than IUD >250mm2 and Norplant-2 users. The LNG-20 IUS was more effective in preventing either intrauterine or extrauterine pregnancies than IUDs <=250mm2. The contraceptive effectiveness of Progestasert was significantly better than non-medicated IUDs, but no difference was observed when compared to IUDs<=250mm2. Continuation of LNG-20 IUS use was similar to continuation of the non-hormonal IUDs and Norplant-2. Amenorrhoea was the main reason for the discontinuation for the LNG-20 IUS and women should be informed of this prior to starting this method.

Long-acting, injectable contraceptives first became available in the 1960s. It is currently estimated that almost 3.5 million women are now using depo-medroxyprogesterone acetate (DMPA); 800,000 are using norethindrone enanthate (NET-EN), and another few hundred thousand are using a variety of once-a-month injectables comprised of progestin plus estrogen. The advantages of injectable contraceptives are that they are highly effective, independent of coitus, easily administered, and they ensure regular contact with health services personnel. The last factor may be considered a disadvantage by some, since contact is more frequent than would be required for routine health services. The major disadvantage of the progestin-only formulations is disruption of normal menses, giving rise to unpredicted episodes of bleeding and spotting. With the once-a-month formulation, on the other hand, there are few discontinuations due to disruption of menses. For a long-acting method to be used longer than 6 months, it is desirable to choose an implant, since the method can be discontinued at will. The first implant system to be developed was Norplant, a set of six rubber capsules filled with levonorgestrel and implanted under the skin. The implant releases sufficient levels of medication to protect against pregnancy. For the first 5 years, the average failure rate was four or five per thousand users per year. The failure rate for women using standard oral contraceptives is approximately 20 to 50 per thousand. The most common side effect of the implant method is the disruption of the menstrual cycle, an effect that is particularly marked in the first month of use.(ABSTRACT TRUNCATED AT 250 WORDS)