Benefits of vaginal dinoprostone administration prior to levonorgestrel-releasing intrauterine system insertion in women delivered only by elective cesarean section: a randomized double-blinded clinical trial.

PURPOSE: This study aimed at investigating the efficacy and safety of dinoprostone 3 mg vaginally prior to levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in women undergoing elective cesarean delivery (CD). METHODS: We conducted a prospective, randomized, double-blinded, placebo-controlled trial at family planning clinic of Cairo University hospitals from August 2019 to January 2020. We included 200 women aged ≥ 18 years who previously delivered by elective CD willing to receive LNG-IUS. Women were randomly assigned with a 1:1 allocation ratio to receive 3 mg vaginal dinoprostone or placebo tablets two hours before LNG-IUS insertion. Our main outcomes were patient-reported pain during insertion and 30 min post-procedure, ease of insertion, satisfaction, duration of insertion, and different side effects. RESULTS: Patient-perceived pain during LNG-IUS insertion was significantly reduced in dinoprostone compared to placebo (4.1 ± 1.7 vs 6.4 ± 1.3; p < 0.001). Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6; p = 0.25). Satisfaction score was higher in dinoprostone compared to placebo (7.9 ± 1.0 vs 5.9 ± 0.8; p < 0.001). The insertion was significantly easier and shorter in dinoprostone than placebo (3.9 ± 1.1 vs 5.9 ± 1.1; p < 0.001) and (5.6 ± 0.9 vs 7.2 ± 0.8; p < 0.001), respectively. Adverse events were not significantly different between both groups. CONCLUSION: Dinoprostone administration 2 h before LNG-IUS insertion in women delivered by elective CD effectively reduced pain during insertion and 30 min post-procedure. Women received dinoprostone had easier and shorter insertion and were more satisfied with tolerable side effects.

Disease activity and thromboembolic events in women with systemic lupus erythematosus with and without anti-phospholipid syndrome: users of the 52-mg levonorgestrel-releasing intrauterine system.

PURPOSE: The disease status and thromboembolic events in women with systemic lupus erythematosus (SLE), with and without anti-phospholipid syndrome (APS), were evaluated before and after placement of the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS). METHODS: A retrospective cohort study, with review of medical records of SLE women, who received an LNG-IUS placement between January 2007 and December 2016, carried out at the University of Campinas Medical School, Brazil. The outcomes included the disease activity (SLEDAI-2K) and damage index scores (SLICC/ACR-DI) presented for each year of device use, as well as venous/arterial thrombotic events, insertion up to a median of 5 years. The author's used χ2, Fisher's exact and the Mann-Whitney tests for analysis and generalized estimating equations for score comparison. RESULTS: The study evaluated 46 women with SLE, 18 with and 28 without APS; the mean age (± standard deviation [SD]) was 31.8 (SD ± 8.3) years old. The length of follow-up after LNG-IUS placement was 5.6 (SD ± 2.7) and 4.1 (SD ± 2.3) years for the groups with and without APS, respectively. Comparison of the groups found that the SLEDAI and SLICC mean scores were low for both at baseline, without variations through the follow-up. After LNG-IUS placement, two women presented three thrombotic arterial events, and one of them died from causes unrelated to LNG-IUS use. CONCLUSIONS: Our results, although restricted, provide information to policymakers and health professionals that the use of a 52 mg LNG-IUS over a 5-year median did not increase disease activity or damage index scores among women with SLE, with and without APS.

Effectiveness of progestin-based therapy for morbidly obese women with complex atypical hyperplasia.

OBJECTIVE: While progestins can effectively treat women with complex atypical hyperplasia (CAH), the impact of body habitus on treatment outcome is not well studied. We examine the association between body mass index (BMI) and progestin treatment outcomes. METHODS: We conducted a retrospective cohort study of patients diagnosed with hyperplasia between 2003 and 2011. Demographics, past medical history, BMI, hormonal therapy, and histologic treatment response were abstracted. Patients with CAH who received progestin therapy were examined, and rates of regression were assessed. RESULTS: Of 623 patients identified, 117 had CAH and satisfied the inclusion criteria. Median age was 34, and nearly, two-thirds (64%) were nulliparous. Mean BMI was 40.2, and 81% were obese (BMI 30-39.9: 36%, BMI ≥ 40: 45%). 103 patients (88%) received systemic progestin therapy and 14 patients (12%) received levonorgestrel-releasing intrauterine devices (LNG-IUS). 47 patients (40%) had a complete response to progestin-based therapy. BMI had no effect on the rate of complete response. The proportions of CAH patients with complete regression after hormonal therapy were BMI < 30: 39%, 30-39.9: 40%, and ≥ 40: 36% (P = 0.73). Women treated with LNG-IUS displayed higher rates of complete regression than those receiving systemic therapy (62% versus 38%, P = 0.096), and those with class III obesity were more likely than non-obese patients to receive LNG-IUS although neither reached statistical significance (< 40: 6.7% versus ≥ 40: 17%, P = 0.09). CONCLUSION: In this morbidly obese population, response to progestin therapy was generally low; body habitus did not impact treatment outcome for CAH, but local therapy may be more effective than systemic therapy.

[Efficacy and adverse effects of levonorgestrel-releasing intrauterine system in treatment of adenomyosis].

OBJECTIVE: To evaluate the efficacy and adverse effects of levonorgestrel-releasing intrauterine system (Mirena) in the treatment of adenomyosis. METHODS: The clinical data of 75 patients with adenomyosis who had Mirena insertion in Women's Hospital,Zhejiang University School of Medicine from September 2013 to December 2013 were retrospectively analyzed. The patients were followed up to 39 months. The efficacy and adverse effects were assessed. RESULTS: Pictorial Blood Loss Assessment Chart (PBAC) scores were decreased significantly after Mirena insertion both in patients with menorrhea (118±13 vs. 29±33, P<0.01) and normal menstruation (82±15 vs. 14±13, P<0.01); the patients with menorrhea showed a more significant decrease in PBAC score than those with normal menstruation (90±35 vs. 69±19,P<0.01). The visual analogue scale (VAS) score decreased significantly after Mirena insertion compared with pre-treatment[7(6,7) vs. 1(0,2), P<0.01]. The expulsion of Mirena occurred in 18 cases (24.0%); 9 cases (12.0%) had no effect and 28 cases (37.3%) had changes of menstruation patterns. Multivariate Cox regression analysis showed that the expulsion of Mirena was not associated with post-treatment VAS score, PBAC score before and after treatment or menstrual stabilization time (all P>0.05). CONCLUSIONS: Mirena is effective and safe in the long term management of adenomyosis, but about one third patients may require further treatment because of the expulsion or ineffectiveness of Mirena.

Prescribing contraception for young women.

BACKGROUND: Since 2002, specially qualified nursing sisters and midwives have had the right to prescribe contraceptive pills for women aged 16 to 19. This arrangement has since been expanded to cover hormonal contraception, with the exception of the hormonal coil. The purpose of this study is to evaluate the arrangement. MATERIAL AND METHOD: The prescription register uses pseudonyms and contains a number of facts about user, medication and prescriber. A database of women born in 1989, totalling 29,821, has been designed as a unit for analysis. RESULTS: 75 and 79% of the cohort had filled at least one prescription for contraceptive pills or hormonal contraception by the end of the calendar year in which they turned 19. Almost 12% had filled at least one prescription for the mini-pill, while far fewer had filled prescriptions for vaginal hormone ring, contraceptive injection, contraceptive patch or hormonal coil. Doctors issued two third of the prescriptions. Nursing sisters wrote more prescriptions than doctors for the age group 17-18. The period of time during which they had been using the contraceptive pill and the mini-pill did not depend on who prescribed them. INTERPRETATION: The fact that close to 80% of the cohort born in 1989 has filled at least one prescription for hormonal contraception shows that there is a high degree of awareness about preventing unplanned pregnancy. Extending the right to write prescriptions to nurses and midwives has increased the availability of contraception, and young women are taking advantage of this option.

Use of the levonorgestrel-releasing intrauterine system: an Austrian perspective.

Approximately 12 million women worldwide use the levonorgestrel-releasing intrauterine system (IUS), with approximately 180,000 users of this IUS currently reported in Austria. A patient satisfaction study of 591 women in Austria revealed a high number of 'very satisfied' (79%) and 'satisfied' (19%) patients. Reliability, comfort, excellent compatibility and less severe, shorter and less painful monthly periods were the most frequently named advantages of the levonorgestrel-releasing IUS. Medication-induced cervical priming before insertion can be carried out on a routine or selective basis (for example in nullipara, in women who have undergone cervical conisation or in women who have previously experienced painful insertion). There is, at present, no evidence of an increased rate of breast cancer through use of the levonorgestrel-releasing IUS. A directly comparative study with oral contraceptives in young nullipara showed excellent results for the levonorgestrel-releasing IUS, with no perforations, inflammation or pregnancies.

Levonorgestrel-releasing intrauterine system: why do some women dislike it?

BACKGROUND: There is growing evidence of women's dissatisfaction with the levonorgestrel-releasing intrauterine system (LNG-IUS) because of a high incidence of adverse effects. OBJECTIVE: To quantify the continuation rate and users' satisfaction, and identify symptoms associated with early removal before the 5-years effective life-time. METHOD: A questionnaire was sent to 212 women, who had LNG-IUS inserted from 1 January 1998 to 31 December 2003 at The Ipswich Hospital, UK. RESULTS: The response rate was 76% (n = 161), 16 of the respondents were excluded and the data of 145 are presented. The continuation rate was 85%, 70%, 59%, 56%, 50% and 50% at 6 months, 1, 2, 3, 4 and 5 years, respectively. The total number of women who had the LNG-IUS removed before 5 years was 72 (50%), and the median duration of use was 270 days (range 4-1460). The reasons for early removal were unscheduled bleeding, progestogenic adverse effects, abdominal pain and others in 40 (28%), 32 (22%), 19 (13%) and 19 (13%) women, respectively. Only 73 (50%) women were satisfied with LNG-IUS. CONCLUSIONS: Our findings are similar to recent reports, and this information should be readily available to women to enable them to make an informed choice.

United States regulatory considerations for intrauterine progestins for hormone replacement therapy.

This paper presents information about U.S. Food and Drug Administration (FDA) considerations for intrauterine progestins as part of a hormone replacement therapy strategy. Current U.S.-approved intrauterine systems are reviewed as well as FDA formal guidance to industry regarding clinical evaluation of combination hormone products. The formal guidance is contrasted with FDA actions for approved combination products, and recommendations for proceeding with a development plan for an intrauterine delivery approach are discussed.

The levonorgestrel-releasing intrauterine system: an updated review of the contraceptive and noncontraceptive uses.

The levonorgestrel containing intrauterine system is an effective and safe form of long-term yet reversible birth control. Intrauterine contraception use in the United States fell dramatically after early studies reported an association between intrauterine contraception use and later tubal infertility. Subsequent evaluation suggests that these early studies were biased. Users often experience menstrual disturbances. Informing patients of these common side effects is important to improve compliance. In addition to its contraceptive effect, the levonorgestrel intrauterine system offers potential therapeutic benefits in other clinical contexts, including menorrhagia, symptomatic fibroids, endometriosis, and endometrial suppression.

Miniature, low-dose, intrauterine drug-delivery systems.

The safety of systemically administered sex steroids continues to be a major focus of researchers. The negative results of the Women's Health Initiative study (WHI), and follow-up reports published in JAMA, evaluating the safety of estro-progestogen in postmenopausal women, elicited an unprecedented reaction in the press by women and doctors alike. From these publications, it is clear that research should focus on new progestogens and on alternative administration routes to minimize adverse drug effects. One approach to the improvement of safety, efficacy, and acceptability of steroid hormones, including patient compliance, is to develop long-acting implantable methods that deliver the lowest possible dose to the key target tissues. This therapeutic concept of "minimal intervention" has been known for several decades, but the practical applications of the method were lacking. Intrauterine drug-delivery systems can be developed to achieve minimal intervention fertility control without influencing normal ovarian function and/or causing adverse hormonal effects. With hormone replacement therapy in postmenopausal women, research suggests that progestogens delivered directly to the uterine mucosa could reduce side effects and minimize reversal of the beneficial effect of estrogens. Various "frameless" and "framed" intrauterine systems are currently being clinically evaluated. They are less troublesome than the available intrauterine systems and could therefore be suitable for use in the majority of women for contraception and treatment purposes (e.g., menorrhagia, hormone replacement). These systems require a single short office procedure, and have a low morbidity, which is undeniably linked with more invasive methods and systemic hormonal contraceptives. Due to the technological progress miniature, low-dose, long-term intrauterine drug-delivery systems offer enhanced effectiveness, reduced side effects, and optimal user compliance. Although there is minimal absorption in the systemic circulation, they deserve the status of a locally acting method that should be regarded as fundamentally advantageous, if effective, to systemically applied medications that may have potentially inherent ill side effects.

The levonorgestrel intrauterine system: a clinical perspective from the UK.

The main contraceptive effects of this valuable product [the levonorgestrel intrauterine system (LNG-IUS)] are by endometrial suppression and changes to the cervical mucus and uterotubal fluid that impair sperm migration. The blood levels of LNG are very low, so progestogenic symptoms are uncommon. Most women still ovulate and in the remainder sufficient estrogen for health is produced from the ovary, even if they become amenorrhoeic, as many do; this is primarily a local end-organ effect and should be seen as a benefit. Although usable by selected nulliparae, it is ideal for the parous woman. It has unsurpassed efficacy, and return of fertility is rapid. Combining the best features of hormonal and intrauterine contraception, its gynecological benefits are impressive: the LNG-IUS user can expect a dramatic reduction in the amount and, after the first few occasionally troublesome months, in the duration of blood loss. Hemoglobin levels rise and dysmenorrhea is usually greatly benefited, unlike with current uterine ablation techniques. In perimenopausal women, it can protect the endometrium from overstimulation when estrogen replacement therapy (ERT) is added, by any chosen route. It thus provides a contraceptive modality of ERT with, usually, no bleeding and few progestogenic side effects-and is applicable before final ovarian failure. In summary, adverse side effects are few and in general they are not in the "hazardous" category. Regarding the admitted inconvenience of the first weeks of light postinsertion bleeding and the early phase low incidence of steroidal side effects: good counseling is paramount, since forewarned is forearmed!

Benefit-risk assessment of the levonorgestrel intrauterine system in contraception.

The levonorgestrel-releasing intrauterine system (IUS) is a long-acting, fully reversible method of contraception. It is one of the most effective forms of contraception available, and combines the advantages of both hormonal and intrauterine contraception. The levonorgestrel-releasing IUS also gives the users many non-contraceptive benefits: the amount of menstrual bleeding and the number of days of menstrual bleeding are reduced, which makes it suitable for the treatment of menorrhagia (heavy menstrual blood loss). Dysmenorrhoea (painful menstruation) and premenstrual symptoms are also relieved. In addition, the levonorgestrel-releasing IUS provides protection for the endometrium during hormone replacement therapy. The local release of levonorgestrel into the uterine cavity results in a strong uniform suppression of the endometrial epithelium as the epithelium becomes insensitive to estradiol released from the ovaries. This accounts for the reduction in menstrual blood loss. All possible patterns of bleeding are seen among users of the levonorgestrel-releasing IUS; however, most of the women who experience total amenorrhoea continue to ovulate. The first months of use are often characterised by irregular, scanty bleeding, which in most cases resolves spontaneously. The menstrual pattern and fertility return to normal soon after the levonorgestrel-releasing IUS is removed. The contraceptive efficacy is high with 5-year failure rates of 0.5-1.1 per 100 users. The absolute number of ectopic pregnancies is low, as is the rate per 1000 users. The levonorgestrel-releasing IUS is equally effective in all age groups and the bodyweight of the user is not associated with failure of the method. In Western cultures continuance rates among users of the levonorgestrel-releasing IUS are comparable with those of other long-term methods of contraception. Premature removal of the device is most often associated with heavy menstrual bleeding and pain, as with other long-term methods of contraception, and is most common in the youngest age group. When adequately counselled about the benign nature of oligo- or amenorrhoea, most women are very willing to accept life without menstruation. The risk of premature removal can be markedly diminished with good pre-insertion counselling, which also markedly increases user satisfaction. User satisfaction is strongly associated with the information given at the time of the levonorgestrel-releasing IUS insertion. Thus, the benefits of the levonorgestrel-releasing IUS make it a very suitable method of contraception for most women.

Hormone-releasing silastic intrauterine devices: effect or provera-releasing intrauterine devices on two species of primates.

Silastic intrauterine contraceptive devices (IUDs) 13 mm long and 1.07 mm in diameter could be inserted easily into patas monkey uteri which, like human uteri, expelled them. Addition of 10% Provera to these devices did not reduce the expulsion rate significantly in our study. Control devices had no effect on cycle length in rhesus monkeys. After insertion, the active IUDs frequently caused a delay in onset of menstruation; however, cycles did occur with the device in situ, and normal-length cycles were resumed following removal of the device. A short period of rapid release (almost 35% of the total amount) of Provera from the device was followed by a longer period of sustained release of low levels of the hormone. Even 9 mug/day were sufficient to maintain a decidual reaction in the endometrium of the rhesus monkey. The drug could not be detected in the blood stream at 3,6, or 12 hours in patas monkeys or at 1 or 2 months in rhesus monkeys and so may never have reached the systemic circulation. Devices currently under study in baboons catain Provera or one of three other steroids to determine whether these compounds improve retention rates as well as meet the other two criteria set for the ideal IUD incorporation, for unless we meet this first criterion we can never achieve, let alone test, the others.

The return of the pharmaceutical industry to the market of contraception.

In the 1980s and 1990s, the litigious climate in the US had a catastrophic effect on sales of many major contraceptives. Although oral contraceptives escaped controversy, the intrauterine device (IUD) and Norplant(R) were two targets of damaging litigation. The IUD was withdrawn from the market in 1985. Since 1994 when the attacks began against Norplant, its US sales have dramatically declined, even though no fault has been found in the method or its development. In general, pharmaceutical companies were extremely hesitant to develop new contraceptives during this period. The bleak outlook, however, began to shift in the late 1990s, as fertility rates began to decrease worldwide and contraceptive users increased. By 2025, 2500 million women will comprise the customer base for contraception. Global pharmaceutical companies are now participating in expanding markets overseas and have launched and continue to develop a range of new long-term reversible, and highly effective, contraceptive products outside the traditional oral contraceptive field. Two new contraceptives on the way to the US market are: Mirena, a levonorgestrel-releasing intrauterine system manufactured by Schering-Leiras; and Implanon, a single implant system manufactured by Organon of the Netherlands. Other birth control methods soon to be launched include: emergency contraceptives, the contraceptive patch, monthly contraceptive injections, mifepristone for medical abortion, and modified oral contraceptives.

The levonorgestrel intrauterine system: therapeutic aspects.

Use of the levonorgestrel-releasing intrauterine system (LNG IUS) is associated with a strong reduction in the number of days of bleeding and menstrual blood loss. This effect is based on the marked local action of the intrauterine release of levonorgestrel (LNG) on the endometrium. In suppressed endometrium the production of many highly active compounds ceases. On the other hand, LNG stimulates the synthesis of some regulatory proteins in the endometrium. Reduction of menstrual blood loss results in improvement of the body iron balance and in an increase in hemoglobin concentration. The LNG IUS has been used in the prevention and treatment of iron deficiency anemia. Many studies have demonstrated that the LNG IUS is effective in the treatment of menorrhagia. Reduction of excessive blood loss is seen as soon as the first menstruation after insertion, and at 1 year the reduction is more than 90%. The therapeutic effect is maintained for more than 5 years after first placement of the LNG IUS in the uterine cavity. Correct insertion is essential, and complications and side effects are rare; fertility is preserved, and invasive procedures such as endometrial ablation or hysterectomy and hospitalization are avoided. The third major indication for therapeutic use is in protection of the endometrium in estrogen replacement therapy during peri- and postmenopausal years. A fundal position of the system in the uterine cavity results in reduction of bleeding, and an increasing number of women have no bleeding at all during use of the IUS. Acceptance and continuation of use of the LNG IUS in hormone replacement therapy (HRT) have been high.

The levonorgestrel intrauterine system in contraception.

The levonorgestrel intrauterine system (LNG IUS) releases 20 microg/24 h of levonorgestrel from a polymer cylinder mounted on a T-shaped frame and covered with a release rate-controlling membrane. It is approved for 5-year use. The most outstanding features of LNG IUS are its high contraceptive efficacy and reduction of menstrual blood flow. No single mode of action can account for its contraceptive efficacy. The endometrium becomes thin and inactive, and the cervical mucus turns scanty and viscous. Although ovulation may be disturbed to some degree, estradiol production continues normally. The Pearl index for LNG IUS from large clinical trials is 0.1. Extrauterine pregnancies occur in 1 in 5000 users per year. Both the volume of menstrual blood loss and the number of bleeding days are reduced. During the first year of use, 20% of women become amenorrheic. There is an initial increase in the mean number of bleeding and spotting days, but in 3 to 6 months the number of bleeding and spotting days is the same as observed in copper IUD-users. The variation between individuals is wide and unpredictable. There are also additional health benefits secondary to the inactivation of the endometrium: increased hemoglobin, decreased dysmenorrhea, a possible decrease in pelvic inflammatory disease. LNG IUS may also decrease the growth of fibroids. LNG IUS is well accepted by users, with typical annual continuation rates above 80% in clinical studies.

WHO study of the progesterone IUD.

PIP: A letter to the editor of the journal, Contraception, concerns an article previously published in that journal entitled "WHO study of the Progesterone IUD," and indicts that article as having ignored standards for scientific reporting of prospective trials of contraceptives. The authors of the complaining letter have attempted to reach the authors of the progsterone IUD paper, but have received no response to their questions; in this article, only a corrigendum from WHO disavowing any knowledge or authorization of the disputed paper constitutes the reply. Objections to the IUD study, which had been published in volume 19, number 6, June 1979, p. 575-589, include discrepancies with study dates, incompleteness of data, improper statistical conclusions of significance, errors in menstruation data, problems with computation of medians, and improper conclusions from existing data. The complainants conclude, "it appears that the contradictions and inaccuracies in the report, as well as the substantial incompleteness of the data being reported, prevent this report from being a scientific document of the material under study."^ieng

An evaluation of the levonorgestrel-releasing IUD: its advantages and disadvantages when compared to the copper-releasing IUDs.

The levonorgestrel-releasing IUD (LNG-IUD-20), providing a daily dose of 20 ug, has recently been approved for marketing in Finland. The IUD's high efficacy in preventing accidental pregnancy and other numerous positive features make it a promising contraceptive device for worldwide use, just like the currently available T-shaped copper-releasing (TCu) IUDs. This paper reviews published reports comparing the LNG-IUD-20 and the currently used TCu IUDs. The merits and disadvantages of the steroid-releasing IUD are evaluated in terms of its performance and other special features relative to the TCu IUDs. Also, a number of future studies with medical and programmatic importance are proposed. A broader understanding about these two IUD families will facilitate their use in a complementary way for family planning programs.

PIP: This literature review compares the merits and disadvantages of the levonorgestrel-releasing IUD made by Leiras Pharmaceuticals, Turkey, Finland (LNG-IUD-20), with the Nova-T, Copper-T (TCu) and 220C, and Copper-T-38-Ag (TCu-380Ag). This IUD releases 20 mcg levonorgestrel daily from a Silastic sleeve on the vertical shaft containing 52 mg. The plasma level stabilized after a month at about 0.2 ng/ml, about half as high as that seen with Norplant implants. It is identical in size to the Nova-T. The Cu-T IUDs differ with respect to copper wire or sleeves, or silver-cored wire. The chief studies reviewed here were 2 multi-center trails primarily in European countries, and a 2 large multi-center trials in India. Cumulative pregnancy rates were 0.0 to 0.6 per 100 users for the LNG IUD, compared to slightly higher failures for inert or copper IUDs. While removal rates for bleeding, pain and pelvic inflammatory disease were lower for the LNG-IUD-20, removals for oligomenorrhea, amenorrhea and hormonal side effects were higher than for the other IUDS. In the Indian trials, removals for amenorrhea and irregular bleeding were much higher than rates reported in the European studies, resulting in significantly lower continuation rates overall. The results pointed to district benefits for the LNG-IUD-20, such as lower blood loss and anemia, relief of dysmenorrhea and menorrhagia, as well as possible lower risks of ectopic pregnancy in case of failure, less PID (pelvic inflammatory disease), and the claim by the maker that strictly correct placement is not necessary. Disadvantages of the LNG-IUD-20 are more difficult insertion due to the wider diameter; oligomenorrhea, amenorrhea and irregular bleeding; hormonal side effects such as acne, weight gain, nausea, headache and breast tension; and potential risk of functional ovarian cysts. The LNG-IUD-20 is considered comparable to copper IUDs in effectiveness, safety, longevity, and return to fertility after removal. Users should be counseled that the oligomenorrhea or amenorrhea is neither a medical problem or indicative of infertility, is common for the 1st 2 months, is reversible on removal, may signal an improved hemoglobin profile, relief of dysmenorrhea, and may be preferred to heavy bleeding from other IUDS. The program implications of this IUD are potential lower incidence of ectopic pregnancy and PID. The effect of its use on breast feeding, cost-effectiveness compared to Norplant, in-country manufacture, and cultural acceptance need to be determined in specific locales.

The acceptability of a combined oestrogen/progestogen contraceptive vaginal ring.

The acceptability of a vaginal ring releasing ethinyl oestradiol 20 mcg per day and norethindrone acetate 1 mg per day was assessed during a six-month phase II trial comparing three different regimens, which was carried out simultaneously in Los Angeles and Sydney. Sixty women were enrolled in Sydney and 90 in Los Angeles. On admission into the study, the women were asked to complete a questionnaire which gave details of age, last contraceptive method used, contraceptive methods used in the past and their reason for liking or disliking previous contraceptive methods, as well as their reason for stopping the last method. On completion of the study or leaving the study for any reason, each woman was asked to complete an acceptability questionnaire which included her experiences with the ring and the rating of the method. The responses to these two questionnaires form the basis of this report. The overall rating of the ring was similar in both the Sydney and Los Angeles groups. Sixty-nine percent of women rated the method as very good. Seventy-two percent of women in Los Angeles and 62% of women in Sydney liked the ring much more than their most liked previous method. In both groups the method they liked best apart from the ring was the pill (62% in Sydney and 53% in Los Angeles). The major reasons for liking the ring were convenience of use, effectiveness and no requirements for taking medication daily. Most women in both studies would recommend the ring to others (92% in Sydney and 89% in Los Angeles).