[Emergency contraception, Levonorgestrel and ectopic pregnancy].
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Contraception, Postcoital↗
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[Emergency contraception with levonorgestrel for teenagers--efficacy, tolerability, and level of information awareness].
OBJECTIVE: Assessment of efficacy and side effects of emergency contraception for teenagers with levonorgestrel (LNG) and the level of users' informedness about possibilities and practical application. METHODS: The subjects are healthy girls (n = 49) with regular menstrual cycles at the age between 15 and 19, having had one unprotected or faultily protected sexual intercourse. All of them have administered 0.75 mg LNG within the 72nd hour, repeated after 12 hours. The data have been processed by variational analysis. RESULTS: One pregnancy was registered of a girl with firstintake at the 67th hour - pregnancy rate - 2,0%. The most frequent side effect was nausea - 26,5%, folowed by breast tenderness - 22,4% and fatigue - 20,4%. An up to 7th day delay in menstrual cycle is non significantly more frequent - 14,3%, followed by a delay of more than 7 days breakthrough bleeding - 8,2%. No significant changes were established in the lenght of the menstrual cycle. Emergency contraception is sought for after unprotected sexual intercourse in 69,4%, and condom failure problems in 30,6%. Only 18,4% have sufficient information about the possibilities and practical use of emergency contraception. CONCLUSION: LNG provides effective, highly tolerable contraception with a small number of side effects. Need is felt for serious popularization of the application of emergency contraception with teenagers.
Adolescent↗
[Emergency contraception with levonorgestrel in adolescents].
OBJECTIVE: The aim of the study was to asses effectiveness and adverse reactions in adolescent girls received Postinor (0.75 mg Levonorgestrel) for emergency contraception. METHOD: Forty-two teenage girls with established regular menstrual cycles for 24 months period and 128 intercourses are included. Excluding criteria are: clinical data for gynecological endocrine diseases, other contraceptive methods used and contraindication for using gestagens. The girls received tablets Postinor containing 0.75 mg levonorgestrel in dosage 1 or 2 pills after non-protected sexual contact. Before the study the girls are examined for their knowledge about fertile period of the menstrual cycle, opportunities of hormonal contraception and about their ability to make adequate decisions in unpredicted situations and complications of the unprotected or inadequate protected intercourse. RESULTS: No one pregnancy occurred during the study period. Main first adverse reactions after receiving Postinor were nausea (12.4%) and intermenstrual bleeding (30.9%), persisting up to three days. Systemic adverse reactions reported from the women were breast tenderness (11.2%), dizziness (6.5%) and headache (5.6%). These side effects were mild and did not require treatment. CONCLUSION: Emergency contraception with Levonorgestrel is effective, with less contraindications compared with other emergency contraception methods. Postinor is available and reliable contraceptive medication.
Adolescent↗
Mifepristone (RU486): a review.
OBJECTIVE: To review the literature concerning the mechanism of action and pharmacodynamics of mifepristone (RU486), potential new uses of RU486, and its current use not only as an abortifacient but also as therapy for endometriosis, leiomyoma, breast cancer, and meningioma. DATA IDENTIFICATION AND SELECTION: Studies that relate to RU486 were identified through a MEDLINE search. CONCLUSION(S): RU486 is an 11 beta-dimethyl-amino-phenyl derivative of norethindrone with a high affinity for P and glucocorticoid receptors. The receptor binding is not followed by transcription of P-dependent genes. Mifepristone effectively blocks P receptors in the placenta, resulting in the termination of pregnancy. In addition, it has been used in the treatment of leiomyomata, endometriosis, advanced breast cancer, and meningioma. It is a powerful tool to study the molecular action of P and in the future may be used as an estrogen-free contraceptive.
Abortifacient Agents, Steroidal↗
Emergency postcoital contraception.
Emergency postcoital contraception, a method used to prevent pregnancy after unprotected sexual intercourse, is a highly effective but underutilized birth control option. Two hormone regimens, ethinyl estradiol (100 microg) with levonorgestrel (0.5 mg) or high-dose levonorgestrel (0.75 mg), given within 72 hours of intercourse and repeated 12 hours later, are available for this purpose. These regimens are packaged as Food and Drug Administration labeled, dedicated products or can be adapted for use from standard oral contraceptive pills. Emergency postcoital contraception should be considered as a primary prevention health service to women of childbearing age.
Abortifacient Agents↗
Adolescent emergency contraception: attitudes and practices of certified nurse-midwives.
Teenage pregnancy has reached epidemic proportions in the United States with I million pregnancies and more than 500,000 live births occurring each year among women under the age of 20. The safety and efficacy of postcoital administration of oral contraceptives, commonly called "emergency contraception" (EC), have been well documented. However, EC is dramatically underused in the United States. Because low use of EC may be attributable, in part, to both lack of knowledge, as well as misinformation on the part of health care providers, further research in this area is warranted. Because midwives play a significant role in the provision of reproductive health care to adolescents, their attitudes about the use of EC among teens may impact the availability of emergency contraception options to these clients. This article presents results of a survey of certified nurse-midwives with respect to their attitudes, practices, and policies related to EC and provides recommendations specific to this provider population.
Adolescent↗
Mifepristone (RU 486): current knowledge and future prospects.
Mifepristone (RU 486) has received recent attention for its effects as an abortifacient. Mifepristone has not yet been approved for use in the United States. The Food and Drug Administration issued an "approvable letter" in September 1996, but mifepristone will not be available in the United States until a new manufacturer is found. Experience with mifepristone is extensive in Europe, and there have been retrospective studies and large, controlled clinical trials of its efficacy. It is most efficacious when administered to women who are less than 8 weeks pregnant, in a single 600-mg oral dose followed 48 hours later by administration of intravaginal misoprostol. This regimen has a success rate of 98%, as do most surgical abortive procedures. The most frequent adverse effect is painful contractions, which occur in up to 93% of women, with oral analgesia required in as many as half the cases. Large-scale surveys of women who elected medical abortion reported high patient satisfaction. Mifepristone is likely to have additional clinical uses. Researchers are exploring mifepristone's potential uses in cervical ripening and labor induction; contraception; delivery after intrauterine demise; treatment of breast cancer, unresectable meningioma, and prostate cancer; amelioration of endometriosis; and management of Cushing syndrome.
Abortifacient Agents, Steroidal↗
Tolerability of levonorgestrel emergency contraception in adolescents.
OBJECTIVE: We evaluated the tolerability of emergency contraception in adolescents. Study design In this descriptive study, 1 0.75 mg levonorgestrel tablet was administered to 52 females aged 13-16 with instructions to take the second tablet 12 hours later (unprotected intercourse was not an entry requirement). Participants kept diaries of side effects and menstrual patterns. We assessed correct use, side effects caused by treatment, and impact on menstrual cycle. RESULTS: Virtually all participants used the drug correctly, with no serious adverse events. Minor expected side effects occurred, including nausea, fatigue, and vomiting. There was no difference in reporting of side effects by age. Adolescents' mean duration of menses was comparable pre- and post-treatment (5.3 vs 5.0 days; P=.146), and onset of menses was within the expected range. Ninety percent of participants reported they would recommend emergency contraception to a friend or relative if needed. CONCLUSION: Adolescents tolerated the medication well, experiencing transient side effects.
Adolescent↗
Expanded clinical trial of emergency contraception with 10 mg mifepristone.
We conducted a clinical single-arm trial to evaluate the effectiveness of 10 mg mifepristone for emergency contraception (EC) in a large population in China. The participating centers were 31 family-planning clinics and hospitals in the following 19 provinces or municipalities in China: Beijing, Shanghai, Tianjin, Harbin, Changchun, Shengyang, Shijiazhuang, Zhengzhou, Taiyuan, Nanjing, Jinan, Hangzhou, Guangzhou, Wuhan, Changsha, Chongqing, Guiyang, Chengdu, Kunming. A total of 4945 women requesting EC within 120 h after a single act of unprotected intercourse were recruited and treated with 10 mg mifepristone. A total of 28 women were lost to follow-up, and 4917 women were included in the analysis, of whom, 69 became pregnant. The combined pregnancy rate was 1.4 [95% confidence interval (CI): 1.0-1.9] and the percentage of pregnancies prevented was 82.2% (95% CI: 77.5-86.2%). There was a significant inverse trend in pregnancy rate with body mass index that disappeared when adjusted for other variables. The pregnancy risk was double among nulliparous women compared to parous women (2.3% compared to 1.0%), and it increased by a factor of 1.5 when the treatment was administered at 25-48 h and at 49-72 h compared to administration within 24 h, although this association was not significant. The risk of pregnancy was higher if intercourse took place during the follicular or preovulatory phase of the cycle. Women having repeated intercourse after treatment without any contraceptive methods had a dramatic increase in the risk of pregnancy, while those who used contraceptives had similar risk to those without acts. Side effects were mild and present in only small proportions of women: nausea and vomiting in 9% and other side effects in 2-3%. Delay of menstruation of 7 days or more occurred in 6.5% of women. The expanded study confirmed the high efficacy and safety of 10 mg mifepristone for EC.
Adult↗
Effect of emergency contraception with levonorgestrel or mifepristone on ovarian function.
The mechanism of action of levonorgestrel (LNG) and mifepristone (MIF) in emergency contraception (EC), is still not fully known. The purpose of this study was to evaluate the effect of preovulatory treatment with LNG and MIF on luteal function in more detail. Two days prior to ovulation (day -2; assessed by ultrasound), we administered LNG (0.75 mg twice, 12 h apart) or MIF (10 mg, single dose) to seven women in different cycles. Follicle development was followed by ultrasound. Urinary estrone glucuronide (E1), pregnanediol glucuronide (P4) and luteinizing hormone (LH) were analyzed by enzyme immunoassays daily starting with day -2 for the rest of the menstrual cycle, along with urinary creatinine (C). The treatment caused either a delay or an inhibition of the LH peak in all subjects. A significant delay in P4 levels and an initial suppression of E1 levels were also noted. The development of the leading follicle was either arrested or continued without signs of rupture. This study indicates that, when used for EC, LNG or MIF administered prior to ovulation acts through an impaired ovulatory process and luteal function.
Contraceptives, Oral, Synthetic↗
Pituitary-ovarian function following the standard levonorgestrel emergency contraceptive dose or a single 0.75-mg dose given on the days preceding ovulation.
We assessed to what extent the standard dose of levonorgestrel (LNG), used for emergency contraception, or a single dose (half dose), given in the follicular phase, affects the ovulatory process during the ensuing 5-day period. Fifty-eight women were divided into three groups according to timing of treatment. Each woman contributed with three treatment cycles separated by resting cycles. All received placebo in one cycle, and standard or single dose in two other cycles, in a randomized order. The diameter of the dominant follicle determined the time of treatment. Each woman had the same diameter assigned for all her treatments. Diameters were grouped into 33 categories: 12-14, 15-17 or 18-20 mm. Follicular rupture failed to occur during the 5-day period in 44%, 50% and 36% of cycles with the standard, half dose and placebo, respectively. Ovulatory dysfunction, characterized by follicular rupture associated with absent, blunted or mistimed gonadotropin surge, occurred in 35%, 36% and 5% of standard, single dose or placebo cycles, respectively. In conclusion, LNG can disrupt the ovulatory process in 93% of cycles treated when the diameter of the dominant follicle is between 12 and 17 mm. It is highly probable that this mode of action fully accounts for the contraceptive efficacy as well as the failure rate of this method. The present data suggest that half the dose may be as effective as the standard dose.
Adolescent↗
Comparison of vaginal and oral administration of emergency contraception.
OBJECTIVE: To compare the physiologic effects of vaginally and orally administered emergency contraception. DESIGN: Prospective, open-label, crossover study. SETTING: University research center. PATIENT(S): Nine regularly menstruating volunteers. INTERVENTION(S): Five subjects received 1,000 microg of levonorgestrel with 200 microg of ethinyl E2 (twice the standard Yuzpe regimen dose) vaginally, and the standard Yuzpe regimen dose orally 1 week later. Four subjects received 1,500 microg of levonorgestrel (twice the standard Plan B regimen dose) vaginally and received the standard Plan B dose orally 1 week later. Serum samples were obtained at baseline and at frequent intervals after each dose. MAIN OUTCOME MEASURE(S): Serum gonadotropin, hepatic globulin, and androgen levels measured at baseline, at the time of peak levonorgestrel, and 24 hours later. RESULT(S): Gonadotropin, hepatic globulin, and androgen levels were suppressed to a similar degree among the four regimens, with a return to baseline levels after 24 hours. CONCLUSION(S): We conclude that high doses of levonorgestrel found in emergency contraception regimens lead to a transient direct suppression of gonadotropin, hepatic globulin, and androgen levels. This effect is similar after vaginal and oral administration of emergency contraception. Therefore, the vaginal route of administration of emergency contraception regimens may be as efficacious as the oral route.
Administration, Intravaginal↗
Emergency contraception with mifepristone and levonorgestrel: mechanism of action.
OBJECTIVE: To study the effect of mifepristone and levonorgestrel on ovarian function and endometrial development in doses effective as emergency contraception. METHODS: Twelve fertile women were treated with either 10 mg of mifepristone as a single dose (n = 6) or two doses of 0.75 mg of levonorgestrel, 12 hours apart (n = 6) before and after ovulation. An endometrial biopsy performed during the implantation period was analyzed for endometrial maturation and expression of markers of endometrial receptivity. The markers tested for were integrin alpha4 and beta3, cyclooxygenase-1 and -2, progesterone receptors, Dolichos biflorus agglutinin lectin binding, and pinopodes. Urinary excretion of luteinizing hormone, estrone, and pregnanediol were also determined. RESULTS: Treatment with mifepristone and levonorgestrel before ovulation inhibited the luteinizing hormone surge showing no significant differences between the means of luteinizing hormone measurements. When mifepristone was administered in the early luteal phase, downregulation of progesterone receptors was inhibited in five of six women. No significant alteration was found in any of the remaining markers of endometrial receptivity. CONCLUSION: The mode of action of emergency contraception with mifepristone or levonorgestrel is primarily due to inhibition of ovulation rather than inhibition of implantation.
Adult↗
Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial.
BACKGROUND: 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: 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.
Adult↗
[Present and potential uses of mifepristone in gynecology, obstetrics and other medical specialties].
Mifepristone, a derivative of norethindrone, a first generation synthetic progestative, has a very potent antiprogestative activity and to a lesser degree antiandrogenic and antiglucocorticoid activities. This action makes it potentially useful in the treatment of multiple hormone dependent diseases in obstetrics-gynecology as well as in a variety of medical specialties such as neurology, ophthalmology, and oncology. Nevertheless, the label of abortive pill has incited numerous ethical and political debates concerning the permission to market this drug, and this has contributed to the delay in the assessment of the potential indications of mifepristone. Largely under-utilized in practice despite its increasing theoretical benefit, clinical studies should now de conducted. Thus, based on an international review of literature during the last ten years, we have shed light on the present and potential indications of mifepristone in medical practice.
Abortifacient Agents, Steroidal↗
Potential antifertility agents. 5. 2,3-Diphenyl-1-(N-methyl-N-propargyl)aminoindenes.
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Alkynes↗
Mifepristone: contraceptive and non-contraceptive uses.
Mifepristone is an orally active progesterone antagonist. It can be used for both contraceptive and non-contraceptive clinical indications. It is a very effective drug for emergency contraception with a low incidence of side effects. There is a potential for mifepristone to be used as a once-a-month pill. There is a need, however, for a simple, inexpensive and accurate method to identify the luteinizing hormone surge before this method can be used in clinical practice. The daily administration of mifepristone offers promise as an effective method of contraception but more studies need to be done. The combination of mifepristone with a prostaglandin analogue is a well-established method for termination of pregnancy of up to 9 weeks. Recent data suggest that this combination may also be used up to 9-13 weeks of pregnancy. Although mifepristone is effective in dilating the cervix before vacuum aspiration, misoprostol is probably the drug of choice in most situations. In the second trimester, mifepristone is effective in shortening the abortion process induced by prostaglandin analogues. The combination of mifepristone and prostaglandin also offers a medical method for management of miscarriages. Mifepristone has been used for a number of other indications, but further studies are needed before such treatment can be recommended.
Abortifacient Agents, Steroidal↗
Cost savings from use of emergency contraceptive pills in Australia.
BACKGROUND: Emergency contraception, which prevents pregnancy after unprotected sexual intercourse, has the potential to reduce significantly the incidence of unintended pregnancy and the consequent need for abortion and to reduce medical care costs. AIM: To determine the savings generated by use of Postinor-2, the levonorgestrel regimen of emergency hormonal contraception, in Australia. METHODS: We modelled the cost savings when women obtain Postinor-2 directly from a pharmacist where cost savings are measured as the cost of pregnancies averted by use of Postinor-2 per dollar spent on Postinor-2. RESULTS: Each dollar spent on a single treatment with Postinor-2 saves A$2.27-A$3.81 in direct medical care expenditures on unintended pregnancy depending on assumptions about savings from costs avoided by preventing mistimed births. Postinor-2 is cost-saving even under the least favourable assumption that mistimed births when prevented today occur 2 years later. Results are robust even to large changes in model input parameters. CONCLUSION: Emergency contraception is cost saving. More extensive use of emergency contraception could save considerable medical and social costs by reducing unintended pregnancies, which are expensive.
Australia↗