A randomised study comparing a low dose of mifepristone and the Yuzpe regimen for emergency contraception. Comparison of Yuzpe regimen, danazol, and mifepristone (RU486) in oral postcoital contraception. Mifepristone (RU 486) compared with high-dose estrogen and progestogen for emergency postcoital contraception. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Task Force on Postovulatory Methods of Fertility Regulation. Comparison of three single doses of mifepristone as emergency contraception: a randomised trial. Task Force on Postovulatory Methods of Fertility Regulation. The effect of dose of mifepristone and gestation on the efficacy of medical abortion with mifepristone and misoprostol. A randomized double-blind comparison of two single doses of mifepristone for emergency contraception. Randomized comparison of vaginal (200 microg every 3 h) and oral (400 microg every 3 h) misoprostol when combined with mifepristone in termination of second trimester pregnancy. Effect of oral prostaglandin E2 on uterine contractility and outcome of treatment in women receiving RU 486 (mifepristone) for termination of early pregnancy. Termination of early pregnancy by two regimens of mifepristone with misoprostol and mifepristone with PG05--a multicentre randomized clinical trial in China. Pregnancy termination with mifepristone and gemeprost: a multicenter comparison between repeated doses and a single dose of mifepristone. World Health Organization. Induction of early abortion with mifepristone (RU486) and two different doses of prostaglandin pessary (gemeprost). Assessment of two emergency contraceptive regimens in Iran: levonorgestrel versus the Yuzpe. Mifepristone (RU 486) induces embryo expulsion in first trimester non-developing pregnancies: a prospective randomized trial. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial. A randomized comparative study on mifepristone alone and in combination with tamoxifen for emergency contraception. A novel estrogen-free oral contraceptive pill for women: multicentre, double-blind, randomized controlled trial of mifepristone and progestogen-only pill (levonorgestrel). Comparison of two doses of mifepristone in combination with misoprostol for early medical abortion: a randomised trial. Two mifepristone doses and two intervals of misoprostol administration for termination of early pregnancy: a randomised factorial controlled equivalence 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.
To compare 100 mg mifepristone with the standard Yuzpe regimen for emergency contraception.
                Randomised controlled trial.
                Family Planning Clinic, Aberdeen.
                One thousand women seeking emergency contraception within 72 hours after an episode of unprotected sexual intercourse.
                Women were randomised to receive either 100 mg (half tablet) of mifepristone as a single dose or the Yuzpe regimen (two tablets each with 50 microg ethinyloestradiol and 0.25 mg levonorgestrel, to be repeated 12 hours later).
                Crude pregnancy rates, proportion of pregnancies prevented, side effects and patient acceptability.
                The crude pregnancy rates (95% CI) for the Yuzpe regimen and mifepristone were 3.6% (2.3-5.7) and 0.6% (0.2-1.8), respectively, with a significant difference between the two groups (RR 6.04; 95% CI 1.75-20.75). Mifepristone prevented 92% of pregnancies and the Yuzpe regimen preventing 56%. An increasing coitus to treatment interval was associated with contraceptive failure in the Yuzpe group (P = 0.03) with no association seen with mifepristone. Following administration of mifepristone 24.5% and 13.1% given the Yuzpe regimen had a delayed period (RR 2.14; 95% CI 1.46-3.15). Overall, mifepristone was better tolerated than the Yuzpe regimen with significantly fewer side effects. More women were satisfied (P < 0.0001) with mifepristone as an emergency contraceptive and would recommend it to a friend (P = 0.02).
                Mifepristone administered in a 100 mg dose is a highly effective post-coital contraceptive with high patient acceptability and fewer side effects compared with the standard Yuzpe regimen. Delay in the onset of menstruation did not decrease patient acceptability. To compare the effectiveness and acceptability of three regimens of postcoital contraception.
                Randomised group comparison of ethinyloestradiol 100 micrograms plus levonorgestrel 500 micrograms repeated after 12 hours (Yuzpe method); danazol 600 mg repeated after 12 hours; and mifepristone 600 mg single dose.
                Community family planning clinic.
                616 consecutive women with regular cycles aged 16 to 45 years.
                Number of pregnancies, incidence of side effects, and timing of next period.
                The raw pregnancy rates (with 95% confidence intervals) for the Yuzpe, danazol, and mifepristone groups were 2.62% (0.86% to 6.00%), 4.66% (2.15% to 8.67%), and 0% (0% to 1.87%) respectively. Overall, these rates differed significantly (chi 2 = 8.988, df = 2; p = 0.011). The differences between the mifepristone and Yuzpe groups and between the mifepristone and danazol groups were also significant. Side effects were more common and more severe in the Yuzpe group (133 women (70%)) than in either the danazol group (58 (30%)) or the mifepristone group (72 (37%)). The Yuzpe regimen tended to induce bleeding early but mifepristone prolonged the cycle. Three women bled more than seven days late in the Yuzpe group compared with 49 in the mifepristone group.
                Mifepristone was effective in reducing expected pregnancy rates and the Yuzpe method also had a clinical effect. Danazol had little or no effect. A further multicentre trial is needed. Mifepristone (RU 486) is a synthetic steroid with potent antiprogestational and antiglucocorticoid properties that provides an effective medical method of inducing abortion in early pregnancy. Since progesterone is essential for implantation, we tested the use of mifepristone for emergency postcoital contraception.
                We studied 800 women and adolescents requesting emergency postcoital contraception who had had unprotected intercourse within the preceding 72 hours. A total of 398 women and adolescents were randomly assigned to treatment with 100 micrograms of ethinyl estradiol and 1 mg of norgestrel, each given twice 12 hours apart (standard therapy), and 402 women and adolescents were randomly assigned to receive 600 mg of mifepristone.
                None of the women and adolescents who received mifepristone became pregnant, as compared with four of those who received standard therapy; the difference in failure rates between the two regimens was not statistically significant. The number of pregnancies in each group was significantly lower than the number expected according to calculations based on the day of the cycle during which intercourse had taken place (P less than 0.001). In many subjects the stage of the cycle as calculated by menstrual history was inconsistent with measurements of plasma progesterone or urinary pregnanediol excretion. The subjects treated with mifepristone reported less nausea (40 percent vs. 60 percent) and vomiting (3 percent vs. 17 percent) on the day of treatment, as well as lower rates of other side effects, than the subjects treated with the standard regimen, but they were more likely to have a delay in the onset of the next menstrual period (42 percent vs. 13 percent).
                Mifepristone is a highly effective postcoital contraceptive agent that, if used more widely, could help reduce the number of unplanned and unwanted pregnancies. A previous randomised study suggested that the progestagen, levonorgestrel, given alone in two separate doses each of 0.75 mg caused nausea and vomiting in fewer women and might be more effective than the Yuzpe regimen of combined oral contraceptives for emergency contraception, although the difference was not significant. We compared these two regimens when started within 72 h of unprotected coitus.
                We enrolled in the double-blind, randomised trial 1998 women at 21 centres worldwide. Women with regular menses, not using hormonal contraception, and requesting emergency contraception after one unprotected coitus, received levonorgestrel (0.75 mg, repeated 12 h later) or the Yuzpe regimen (ethinyloestradiol 100 microg plus levonorgestrel 0.5 mg, repeated 12 h later).
                Outcome was unknown for 43 women (25 assigned levonorgestrel, 18 assigned Yuzpe regimen). Among the remaining 1955 women, the crude pregnancy rate was 1.1% (11/976) in the levonorgestrel group compared with 3.2% (31/979) in the Yuzpe regimen group. The crude relative risk of pregnancy for levonorgestrel compared with the Yuzpe regimen was 0.36 (95% CI 0.18-0.70). The proportion of pregnancies prevented (compared with the expected number without treatment) was 85% (74-93) with the levonorgestrel regimen and 57% (39-71) with the Yuzpe regimen. Nausea (23.1 vs 50.5%) and vomiting (5.6 vs 18.8%) were significantly less frequent with the levonorgestrel regimen than with the Yuzpe regimen (p<0.01). The efficacy of both treatments declined with increasing time since unprotected coitus (p=0.01).
                The levonorgestrel regimen was better tolerated and more effective than the current standard in hormonal emergency contraception. With either regimen, the earlier the treatment is given, the more effective it seems to be. Mifepristone is a highly effective and well-tolerated emergency contraceptive when given in a dose of 600 mg within 72 h of unprotected coitus. We assessed whether the same effectiveness can be achieved with lower doses of mifepristone (50 mg and 10 mg) and a longer postcoital treatment period (120 h).
                We undertook a multicentre, single-masked, randomised trial in 11 family-planning clinics in Australia, China, Finland, Georgia, the UK, and the USA. 1717 healthy women with regular menstrual cycles who requested emergency contraception within 120 h of unprotected coitus were randomly assigned to three treatment groups.
                32 women were lost to follow-up and one was pregnant before treatment. The 600 mg, 50 mg, and 10 mg groups did not differ in the proportions of pregnancies (seven [1.3%] of 559, six [1.1%] of 560, and seven [1.2%] of 565). Two pregnancies (both in the 50 mg group) were tubal. Among women without further acts of intercourse, treatment delay did not appear to influence the effectiveness. No major side-effects occurred, except a delay in the onset of next menses, significantly (p<.001) related to the mifepristone dose.
                Lowering the dose of mifepristone sixty-fold did not decrease its effectiveness as an emergency contraceptive under typical use, though a study of this size cannot exclude differences in effectiveness up to almost three-fold. Lower doses of mifepristone were associated with less disturbance of the menstrual cycle. Thus, a dose as low as 10 mg seems preferable to the 600 mg dose. Although it has been demonstrated that a combination of mifepristone and a prostaglandin is an effective method of inducing abortion in early pregnancy, the optimum dose of the antigestogen is unknown. Women (n = 220) requesting abortion in early pregnancy (< or = 63 days amenorrhoea) were randomized to receive a single dose of either 600 or 200 mg mifepristone followed 48 h later by a single dose of 600 micrograms misoprostol by mouth. The percentage of women who had a complete abortion (93.6% confidence interval 90.4-95.5%) was identical in the two groups. There was no significant difference in the number of women who passed the fetus within 4 h of receiving the prostaglandin (64 versus 74%), the days of bleeding (14.6 +/- 1.1 versus 15.3 +/- 0.9) nor in the onset of the next period (39.7 +/- 1.3 versus 36.7 +/- 1.3) respectively between the groups receiving 200 or 600 mg mifepristone. However, the complete abortion rate was significantly higher in women < or = 49 days compared to women 50-63 days amenorrhoea (97.5 versus 89.1% respectively; P < 0.02). There was no difference in any of the other parameters at different weeks of gestation. We conclude: (i) that the recommended dose of mifepristone could be reduced from 600 to 200 mg without loss of clinical efficacy, (ii) that the combination of mifepristone and 600 micrograms misoprostol is a highly effective alternative to vacuum aspiration for inducing abortion in women < 50 days amenorrhoea and (iii) at gestation > 56 days, this combination may result in too many incomplete abortions to be clinically acceptable. Previous trials have shown the potential of 10 mg of mifepristone in emergency contraception. The aim of this trial was to investigate whether 10 mg of mifepristone has the same efficacy as 25 mg.
                This double-blind, randomized trial was carried out in 10 family planning institutes and hospitals in China. Women who met recruitment criteria and requested emergency contraception within 120 h of a single act of unprotected coitus were randomized using a computer-generated list to either 10 or 25 mg of mifepristone within each centre.
                Among 3052 women enrolled, the outcome was known for 3030 women, 1516 in the 10 mg group and 1514 in the 25 mg group. Seventeen pregnancies occurred in each group, giving a pregnancy rate of 1.1%. The relative risk of pregnancy for women treated with 10 mg mifepristone compared with those treated with 25 mg was 1.0 (95% CI: 0.51-1.95) and equivalence was demonstrated within a two-fold margin. Both doses prevented 85-86% of pregnancies expected to have occurred if no treatment had been given. The pregnancy rate nearly doubled if women had further acts of intercourse. Efficacy decreased with treatment delay. Side-effects were uncommon and mild.
                A dose of 10 mg of mifepristone is sufficient for emergency contraception. Earlier treatment is preferable, although the method can be used effectively for up to 5 days after intercourse. It is known that when misoprostol is given at 200 microg every 3 h after mifepristone pretreatment, the vaginal route is more effective than the oral route. However, women prefer the oral route. This randomized study was to test our hypothesis that oral misoprostol 400 microg is as effective as vaginal misoprostol 200 microg when given every 3 h in termination of second trimester pregnancy after priming with mifepristone. A total of 142 patients was randomly assigned to group 1 (200 mg mifepristone + 400 microg oral misoprostol every 3 h up to five doses) or group 2 (200 mg mifepristone + 200 microg vaginal misoprostol every 3 h up to five doses). The incidence of side-effects and the preference study were assessed through a standardized questionnaire during and after the abortion. For the oral group, both the incidence of diarrhoea (40.0 versus 23.2%, P = 0.03) and the amount of drug used (1734 compared with 812 microg, P < 0.0001) were significantly higher than that of the vaginal group but the incidence of fever appeared to be lower (not significant). There was no significant difference in complete abortion rate: 81.4% in the oral group and 75.4% in the vaginal group. The median induction-abortion interval was similar in the two groups (10.4 versus 10.0 h). The percentage of women who aborted in 24 h was also similar: 57/70 (81.4%) in the oral group and 58/69 (87.0%) in the vaginal group. Overall, 82.0% of women preferred the oral route. Oral misoprostol (400 microg) given every 3 h up to five doses, when combined with mifepristone, was as effective as the vaginal (200 microg) route in second trimester termination of pregnancy. This regimen could also be offered to those women who found repeated vaginal administration unacceptable. It has been shown that the antiprogestin RU 486 (mifepristone) increases the sensitivity of the early pregnant human uterus to the stimulatory action of synthetic prostaglandin E (PGE) analogues. To examine if RU 486 also increases uterine sensitivity to the naturally occurring PGE2 given orally, two investigative approaches were used in the present studies: (i) direct registration of uterine contractions before and after PGE2 administration in untreated and RU 486-treated early pregnant women; and (ii) a double-blind, randomized, controlled efficacy trial involving treatment of pregnant women (amenorrhoea of less than or equal to 49 days) with RU 486 (25 mg twice daily for 4 days) and PGE2 (1 mg once or twice) or placebo on the last day of RU 486 treatment. The results indicate that oral PGE2 at the doses employed had little or no stimulatory effect on uterine contractility and that it did not improve the rate of complete abortion achieved with RU 486 alone. Overall, 25 of 42 women (59%) had a complete abortion, 15 women (36%) did not abort and the remaining two had incomplete abortions. Women with complete abortions had significantly lower pretreatment levels of progesterone and a longer duration of induced bleeding than those who did not abort. Thus oral PGE2, when given in clinically acceptable doses, is not a suitable alternative to synthetic PGE analogues for use in combination with RU 486 for termination of early pregnancy. A multicentre randomized open clinical trial was conducted to compare the efficacy and side effects of two regimens of mifepristone with misoprostol, and mifepristone with PG05 for termination of early pregnancy (amenorrhoea < = 49 days). Six-hundred women in early pregnancy, who requested medical abortion were randomly allocated into 3 groups. In group 1 (n = 301), an initial dose of mifepristone 50 mg was given, followed by 25 mg every 12 hours up to a total dose of 150 mg mifepristone, plus a single oral dose of misoprostol 600 micrograms in the morning of the third day. In group 2 (n = 150), the same regimen of mifepristone was given, but dl-15-methyl PGF2 alpha (PG05) 1 mg vaginal suppository was inserted on the third day. In group 3 (n = 149), a single dose of mifepristone 200 mg was given and misoprostol 600 micrograms was used as in group 1. The complete abortion rate were 94.4%, 97.3%, and 94.6% for group 1, 2 and 3, respectively. 3.0, 2.0 and 2.7% of women had incomplete abortion, and 1.7, 0.7 and 2.0% of women in the 3 groups were treatment failures; in the remaining 1% in group 1 and 0.7% in group 3, treatment outcome could not be determined. There were no significant differences among the 3 groups. Lower abdominal pain was the main complaint which was reported by 82% of the subjects after PGs administration. The incidence of diarrhoea in PG05 group (38.7%) was significantly higher than that in the other two groups (21.6 and 20.1%) (P < 0.001), and so was vomiting. It was concluded that misoprostol, as an orally effective prostaglandin, in combination with mifepristone for induced abortion of early pregnancy was as effective as PG05 vaginal suppository. Besides, it has advantages of convenience of use, less side effects, easy storage and transfer, and low cost. To compare two regimens of mifepristone plus gemeprost for early pregnancy termination.
                A prospective, randomized, multicenter trial.
                Ten gynecological services, mostly in academic hospitals.
                Three hundred eighty-five healthy women up to 35 years of age with amenorrhea less than or equal to 49 days requesting pregnancy termination.
                Mifepristone, 25 mg five times at 12-hour intervals (n = 192) or 600 mg as a single dose (n = 193) followed by 1 mg gemeprost 60 hours after the start of mifepristone.
                Pregnancy outcome, time of onset and duration of vaginal bleeding, subjective complaints, and hormone changes during treatment and 6-week follow-up.
                Treatment outcome was identical in both groups with an overall complete abortion rate of 92.7% among the 385 women included in the analysis. The frequency of complaints, bleeding patterns, and changes in hemoglobin, beta-human chorionic gonadotropin, estradiol, and progesterone were also similar in both groups. Cortisol (at 12 and 36 hours after mifepristone) and prolactin (at 12 hours) were significantly higher in the single 600-mg dose group.
                When used for early pregnancy termination with prostaglandin, a lower dose of mifepristone than the currently recommended single 600-mg dose may suffice. One-hundred-and-twenty women of less than 56 days amenorrhoea were treated with a single dose of 600 mg of mifepristone in combination with half or a whole 1 mg gemeprost vaginal pessary. Complete abortion was induced in 119 (99%) women and there were no continuing pregnancies. There were few gastro-intestinal side effects following prostaglandin. The smaller dose of prostaglandin caused significantly less severe pain. This study confirmed the effectiveness of mifepristone and prostaglandin for the induction of early abortion but suggests that more research should be carried out to determine the lowest effective doses of both drugs. The purpose of this study was to compare the efficacy and tolerability of two emergency contraception (EC) methods, levonorgestrel versus the Yuzpe.
                In a prospective, randomized, comparative study, we included 122 healthy volunteers who in the observed cycle had had only one act of unprotected intercourse within 72 h of treatment. They were randomly allocated in levonorgestrol group (n=62) and Yuzpe (n=60). The levonorgestrel regimen consisted of two pills: 0.75 mg levonorgestrel, taken twice in the 12-h interval within 72 h after unprotected intercourse. The Yuzpe method included two HD contraceptive pills taken as another regimen. Data were collected by questionnaire at first and 3 weeks later. The differences were compared with X2 & Fisher exact tests.
                There were no significant differences between two groups in any of the observed parameters. The levonorgestrel regimen was found superior to Yuzpe because it's more effectiveness (respectively 100% vs 91%, p=0.026) and fewer side effects.
                The study showed more effectiveness and safety of the levonorgestrel regimen as emergency contraception. Thus we recommend levonorgestrel as an alternative EC method instead of the Yuzpe regimen in Iran or other developing countries in order to decrease unwanted pregnancy. This study was designed to investigate the use of oral mifepristone (RU 486) for the induction of natural expulsion of concepti in women with spontaneously interrupted pregnancy in the first trimester. It consisted of a double-blind placebo-controlled study of mifepristone (600 mg) against placebo. A total of 46 women consulting for interrupted pregnancy were diagnosed at ultrasound with no clinical sign of miscarriage. Measurements were made of the occurrence of natural expulsion, the frequency of complete expulsion, the need for subsequent surgical evacuation, analgesia and the need for transfusion. Natural expulsion occurred within 5 days in 82% of patients receiving mifepristone treatment versus 8% of placebo-treated patients (P < 0.001). All patients experienced bleeding after RU 486 and two needed emergency aspiration for haemorrhagic expulsion. The treatment failed in four patients, who underwent evacuation under local anaesthesia. In the control group, 19 patients underwent evacuation under local (n = 10) or general (n = 9) anaesthesia. It was concluded that a standard oral pilot dose of 600 mg of mifepristone induces natural expulsion in 82% of women with non-developing first trimester intrauterine pregnancies. A single 10 mg dose of mifepristone, and two 0.75 mg doses of levonorgestrel 12 h apart, are effective for emergency contraception. Because no studies had compared the efficacies of both compounds, or investigated a single dose of 1.5 mg levonorgestrel, we undertook this three-arm trial.
                We did a randomised, double-blind trial in 15 family-planning clinics in 10 countries. We randomly assigned 4136 healthy women with regular menstrual cycles, who requested emergency contraception within 120 h of one unprotected coitus, to one of three regimens: 10 mg single-dose mifepristone; 1.5 mg single-dose levonorgestrel; or two doses of 0.75 mg levonorgestrel given 12 h apart. The primary outcome was unintended pregnancy; other outcomes were side-effects and timing of next menstruation. Analysis was by intention to treat, but we did exclude some patients from the final analyses.
                Of 4071 women with known outcome, pregnancy rates were 1.5% (21/1359) in those given mifepristone, 1.5% (20/1356) in those assigned single-dose levonorgestrel, and 1.8% (24/1356) in women assigned two-dose levonorgestrel. These proportions did not differ significantly (p=0.83). The relative risk of pregnancy for single-dose levonorgestrel compared with two-dose levonorgestrel was 0.83 (95% CI 0.46-1.50), and that for levonorgestrel (the two regimens combined) compared with mifepristone, 1.05 (0.63-1.76). Side-effects were mild and did not differ greatly between groups, and most women menstruated within 2 days of the expected date. Women who took levonorgestrel had earlier menses than did those who took mifepristone.
                The three regimens studied are very efficacious for emergency contraception and prevent a high proportion of pregnancies if taken within 5 days of unprotected coitus. Mifepristone and levonorgestrel do not differ in efficacy. A 1.5 mg single levonorgestrel dose can substitute two 0.75 mg doses 12 h apart. The purpose of the clinical study was to compare the efficacy and side effects of 10 mg of mifepristone alone (Group 1) and with 20 mg of tamoxifen (Group 2) for emergency contraception, especially as used within 72-120 h after coitus. Four-hundred female volunteers with one act of unprotected intercourse or contraception failure (200 cases in each group) were recruited and completed the study. There were 198 women treated < 72 h after coitus (100 in Group 1 and 98 in Group 2), whereas the remaining 202 patients were treated between 72-120 h (100 in Group 1 and 102 in Group 2). In total, four pregnancies occurred; one treated < 72 h in each group, two between 72-120 h in Group 1. Efficacy for prevention of unwanted pregnancy by Trussell method is 84% for Group 1, and 95% for Group 2, and which is not significantly different between the two groups and even subgroups. The side effects (15.5% for Group 1 and 14.5% for Group 2) and changes in menstruation were infrequent and mild in both groups. Further studies should be conducted to determine whether tamoxifen combined with mifepristone for emergency contraception is more effective as compared with mifepristone alone. The acceptability and continuation rate of oral contraceptive steroids are limited by unpredictable bleeding and the fear of long-term risks such as breast cancer. By inhibiting ovulation and by altering the receptivity of the endometrium, antagonists of progesterone, such as mifepristone, could be developed as estrogen-free novel contraceptives.
                Multicentre, double-blind, randomized controlled trial comparing frequency of amenorrhoea (primary outcome), bleeding patterns, side effects and efficacy in women taking daily 5 mg mifepristone (n = 73) or 0.03 mg levonorgestrel (progestogen-only pill; POP, n = 23) for 24 weeks.
                More women were amenorrhoeic while taking mifepristone than POP (49 versus 0% P < 0.001), and fewer women bled or spotted for >5 days per month (4 versus 39% P < 0.001). Forty-eight percent of women who took mifepristone for 6 months had cystic glandular dilatation of the endometrium but none showed hyperplasia or atypia. There were no pregnancies in 356 months of exposure in women who used only mifepristone for contraception. Two pregnancies occurred in women taking mifepristone who were also using condoms for dual protection.
                Daily mifepristone (5 mg) is an effective oral contraceptive pill which has a better pattern of menstrual bleeding than an existing POP (levonorgestrel). To compare the efficacy of two different regimens of mifepristone followed by misoprostol for medical abortion in women with menstrual delay of < or = 35 days.
                Double-blind, randomised controlled trial.
                Seventeen centres internationally.
                We enrolled 1,589 healthy pregnant women with menstrual delay of < or = 35 days who were requesting nonsurgical abortion.
                Within gestational age strata, we randomly assigned women to receive a single oral dose of mifepristone, either 200 mg or 600 mg, followed in 48 h by misoprostol 400 microg by mouth. We concealed the allocation assignments from investigators and participants and maintained double-blinding throughout the study.
                Complete abortion was the principal outcome measure. We also compared rates of side effects such as abdominal pain.
                The complete abortion rate with the lower dose of mifepristone was similar to that with the higher dose (89.3% vs 88.1%) The crude relative risk of failure to achieve complete abortion with the 200 mg dose compared with the 600 mg dose was 0.9 (95% CI 0.7 to 1.2). The likelihood of complete abortion was inversely related to gestational age, although this finding is exploratory in nature. Among failures the percentage of women with continuing pregnancies increased from 1.4% at menstrual delay of two weeks or less to 9.0% when the delay was 4-5 weeks. Low efficacy led to stopping enrolment at 29 to 35 days' menstrual delay. Stopping criteria were also met at completion of the study in the group with 22-28 days' menstrual delay. No significant differences emerged in the frequency of side effects between the two mifepristone groups.
                Both regimens had similar efficacy. Women with a menstrual delay of four to five weeks had twice the risk of failure to abort compared with those who received treatment within two weeks of the expected menses. The efficacy of the mifepristone-prostaglandin regimen was not reduced by decreasing the dose of mifepristone from 600 mg to 200 mg. The regimens of 600 mg or 200 mg of mifepristone, followed by a single oral dose of misoprostol 400 microg 48 hours later, were not sufficiently efficient in inducing abortion when the menstrual delay was > 21 days. To compare the efficacy of 100 mg and 200 mg of mifepristone and 24- and 48-hour intervals to administration of 800 microg vaginal misoprostol for termination of early pregnancy.
                Placebo-controlled, randomized, equivalence trial, stratified by centre.
                13 departments of obstetrics and gynecology in nine countries.
                2,181 women with 63 days or less gestation requesting medical abortion.
                Two-sided 95% CI for the risk differences of failure to complete abortion were calculated and compared with 5% equivalence margin between two doses of mifepristone and two intervals to misoprostol administration. Proportions of women with adverse effects were compared between the regimens using standard testes for proportions.
                Rates of complete abortion without surgical intervention and adverse effects associated with the regimens.
                Efficacy outcome was analysed for 2,126 women (97.5%) excluding 55 lost to follow up. Both mifepristone doses were found to be similar in efficacy. The rate of complete abortion was 92.0% for women assigned 100 mg of mifepristone and 93.2% for women assigned 200 mg of mifepristone (difference 1.2%, 95% CI: -1.0 to 3.5). Equivalence was also evident for the two intervals of administration: the rate of complete abortion was 93.5% for 24-hour interval and 91.7% for the 48-hour interval (difference -1.8%, 95% CI: -4.0 to 0.5). Interaction between doses and interval to misoprostol administration was not significant (P = 0.92). Adverse effects related to treatments did not differ between the groups.
                Both the 100 and 200 mg doses of mifepristone and the 24- and 48-hour intervals have a similar efficacy to achieve complete abortion in early pregnancy when mifepristone is followed by 800 micrograms of vaginally administered misoprostol. 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.
Intermediate-dose mifepristone (25-50 mg) was superior to LNG and Yuzpe regimens. Mifepristone low dose (< 25 mg) may be more effective than LNG (0.75 mg two doses), but this was not conclusive. UPA may be more effective than LNG. LNG proved to be more effective than the Yuzpe regimen. The copper IUD was the most effective EC method and was the only EC method to provide ongoing contraception if left in situ.