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A study comparing 2 triphasic hormonal contraceptive preparations (combinations of ethinyl estradiol and levonorgestrel) is reported. SH B 264 AB was used by 594 women for 6628 cycles with no pregnancies, while 634 women used SH B 261 AB for 6025 cycles with 1 pregnancy. A lower incidence of breakthrough bleeding and spotting was observed among SH B 264 AB users, and this preparation ("Triquilon") is preferred to the other. Triquilon users had a menstrual cycle length of 26-30 days and an amenorrhea rate of .4%. There was a low rate of breakthrough bleedings and spottings, which was higher when patients forgot to take their pills. In the vast majority of Triquilar users, body weight and blood pressure remained constant. Subjective side effects (e.g. nausea, dizziness, headache) were infrequent and decreased as the length of Triquilar use increased. A separate study of 1440 cycles of Triquilar use and 1343 cycles of Microgynon use showed that, while the contraceptive effectiveness was the same, the incidence of breakthrough bleeding and spotting was significantly less frequent among Triquilar users.
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PMID:[The first three-stage preparation for hormonal contraception. Clinical results (author's transl)]. 11 12

Prevalence rates of various side effects were studied comparatively among 3 oral contraceptive preparations containing 50 mcg of the estrogen component. Norinyl 1/50, Ovral, and Norlestrin 1 were each randomly assigned to groups of 160 healthy women who had consented to participate in the study designed to quantitate probabilities of experiencing specific side effects and of their continuing into the subsequent cycles. Acne, breast discomfort, nausea, abdominal bloating, headache, fatigue, depression, irritability, vaginal discharge, and breakthrough bleeding were the specific side effects studied; only breakthrough bleedings showed a statistical difference in prevalence. The rate of breakthrough bleeding associated with Ovral use in the 1st 3 cycles (16.6%) was significantly (P .05) lower than that associated with using either Norinyl or Norlestrin (46% and 51.7%, respectively). Norelestrin, aside from breakthrough bleeding, was reported as generally freer of side effects than the other 2 preparations. The probabilities of side effects being experienced in the 2nd or 3rd cycle after the effect(s) was experienced in the 1st cycle showed that overall, for all 3 combination pills, the probabilities significantly decreased from the 2nd to the 3rd cycle (P .05). Also examined was the probability that a side effect would occur in the 2nd or 3rd cycle if the user had not experienced such an effect in the 1st cycle. In each instance, the probabilities are significantly lower (P .05) than the corresponding probabilities where the symptom had been experienced in a previous cycle. These data support the contention that side effects experienced on inititation of oral contraceptives should not prohibit its continuation because the majority of symptoms will disappear as the patient becomes accustomed to the hormonal preparation.
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PMID:The probability of side effects with ovral, norinyl 1/50 and norlestrin. 16 Aug 60

A case report of subacute, reversible ischemic colitis associated with use of oral contraceptives (OCs) is reported. A 19-year-old woman was admitted to the hospital with chief complaints of abdominal cramps, nausea, vomiting, diarrhea, and rectal bleeding of 2 days' duration. Past medical history and family history were noncontributory. The patient was receiving no medication other than Norinyl 2 (2 mg of norethindrone and .1 mg of mestranol), which she had been taking for 6 months. 2 days before admission the patient had taken 100 mg of dimenhydrinate and 2 ExLax tablets (90 mg of phenolphthalein) for constipation. Colonic roentgenograms revealed impaired mesenteric circulation and bowel ischemia; OC-induced ischemic bowel disease was diagnosed. Patient symptoms subsided within 96 hours of discontinuing the OC and initiating supportive therapy (including intravenous fluid infusion, nasogastric suction, analgesics, and antiemetics). When a repeat barium enema was performed, it showed resolution of the ischemia. In a short review following the case report, these drugs were indicted in causation of colitis-like syndrome: amoxicillin, ampicillin, cephazolin, chloramphenicol, chlorpropamide, clindamycin, cloxacillin, cotrimoxasole, cyclophosphamide, digitalis, ergotamine tartrate, flucytosine, fluorouracil, gold salts, laxative and cathartic abuse, mercurous chloride, methyldopa, penicillin V, and tetracycline. Ischemic bowel disease secondary to OC use is a rare but important complication because of its significant morbidity and potential mortality, and because of the widespread use of the drugs. The case report emphasizes the need to consider the differential diagnosis of acute vascular insult with bowel ischemia when acute abdominal pain progressing to bloody diarrhea occurs in young women taking OCs.
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PMID:Oral contraceptive-induced ischemic bowel disease. 48 72

Research in the area of oral contraception currently focuses on the development of selective progestogens that combine targeted progestational and antiovulatory activity with a minimal potential for androgenicity. The present dual-center study was conducted to investigate the efficacy, tolerability, and safety of a new monophasic oral contraceptive (OC) containing 250 micrograms norgestimate in combination with 35 micrograms ethinyl estradiol (Ortho-Cyclen or Cilest). Ninety-seven healthy women of childbearing age participated in the study: 37 received the new norgestimate/ethinyl estradiol combination OC as primary therapy and 31 were switched over from other OCs. The norgestimate/ethinyl estradiol formulation was well tolerated and was associated with excellent cycle control. After six cycles of use, there were no statistically significant differences in the incidence of spotting or breakthrough bleeding compared with baseline, nor were there any significant changes in the incidence of headache, nausea, or mastalgia. Body weights remained constant for the duration of the study, as did systolic and diastolic blood pressures. Of particular note was the absence of any statistically significant alterations in metabolic parameters, including blood glucose or lipoprotein levels. These findings are consistent with the results of several other European studies and indicate that the norgestimate/ethinyl estradiol combination OC combines superior cycle control with minimal risk of androgenic side effects.
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PMID:Clinical experience with a new norgestimate-containing oral contraceptive. 134 20

The performance of a new low-dose oral contraceptive (Mercilon) containing only 20 micrograms ethinyloestradiol combined with 150 micrograms desogestrel is reviewed. Eight multicentre clinical trials have been completed and provide information on 10,672 women studied over 73,477 cycles. The high efficacy of Mercilon was indicated by the finding that only 10 pregnancies were reported; nine of these occurred in women who omitted to take Mercilon on a number of days and only one in a woman who took all the tablets according to instructions. Cycle control was good; as with all oral contraceptives, the incidence of breakthrough bleeding and spotting was highest in the first treatment cycle and by the sixth treatment cycle the values were usually < 5% and < 7%. More than 80% of women had regular cycles. Side effects were few, the most common being headache, nausea and breast tenderness with incidences in the sixth treatment cycle of less than 2%, 6% and 6%, respectively. There were no significant changes in body weight or blood pressure. Pharmacodynamic investigations showed no adverse effects. Only 1 of 5 studies found an increased response to a glucose tolerance test compared to the pretreatment test. In 8 of 10 studies, serum HDL-C concentrations increased on treatment and this was associated with increases in apoproteins A1 and A2. Serum triglyceride levels also increased but no change occurred in serum cholesterol or LDL-C levels. Haematological factors were assessed in 8 studies and only minor changes were observed. Serum binding protein (SHBG, CBG, caeruloplasmin) concentrations increased and serum androgen levels decreased. Measurements of blood FSH, LH, oestradiol and progesterone indicated adequate inhibition of ovulation. Mercilon is the only oral contraceptive containing 20 micrograms ethinyloestradiol to have high efficacy, to have no adverse pharmacodynamic effects and, importantly, to produce an acceptable bleeding pattern not significantly different from that of oral contraceptives with a higher content of ethinyloestradiol.
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PMID:Clinical experience and pharmacological effects of an oral contraceptive containing 20 micrograms oestrogen. 145 94

In addition to oral contraceptives (OCs), the morning-after pill, the minipill, and depot preparations also belong to hormonal contraceptives. The latter two contraceptives have not become established among young women because of inadequate cycle control. For postcoital contraception in Austria, Neogynon and Stediril-D, consisting of 0.05 mg of ethinyl estradiol (EE) + 0.25 mg of levonorgestrel, are used within 48 hours of unprotected intercourse. Lower dose OCs have considerably reduced the risks of side effects. Micropills are the optimal OCs with EE under 50 mcg combined with the new generation of gestagens. The beneficial effects include menstrual regularity and the prevention of anemia, ovarian cysts, and fibrocystic mastopathy. Nausea, headache, spotting, and weight gain do occur in individual cases, even among young people. The potential risk of thromboembolism is the most important, although arterial cardiovascular risk is minimal in young age. The probability of postpill amenorrhea is less than 1%. Micropills can be used by young diabetics provided the disease is not beyond 10 years' duration and there is no angiopathy. Acne, seborrhea, and hirsutism are beneficially influenced by a combination of 0.035 mg of EE with 2 mg of cyproterone acetate. The relative risk of endometrial and ovarian cancer are only about half as high among OC users as among nonusers. The risk of breast cancer in young OC users has not been conclusively explained. Regular colposcopy and cytology is recommended for young OC users to preclude the risk of malignancies of the genital tract. Sex education and the use of OCs that are the most suitable and effective for young people can reduce the number of unwanted pregnancies and abortion. The comparison of two 5-year periods in the 1970s and 1980s at the University Obstetrical-Gynecological Clinic in Graz showed that the incidence of births among women under 18 years of age decreased from 3.6% (778) to 1.6% (353).
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PMID:[Benefits and risks of hormonal contraception]. 146 64

A new form of postcoital contraceptive therapy is described as more effective because of reduced incidence of nausea, vomiting, and breast tenderness. Other forms of emergency contraceptive pills (ECPs) are the "Yuzpe" method or high-dose contraceptives. The new method calls for administration of 3 200-mg tablets of danocrine (Danazol) within 72 hours of unprotected intercourse and a second dose 12 hours later. There are mixed reviews of the efficacy of danocrine and ECPs. In one comparative study of ECP and danocrine use, efficacy of danocrine was greater but not significantly so. Another study found danocrine so ineffective that the study was halted. ECP use would not end unintended pregnancies caused by method failure unless it was condom failure. Estimates of ECP use involve 75% of the 1.7 million women with user or method failure, all 1.9 million women with unintended pregnancies from nonuse of contraceptives, and some of the 1.6 million abortion users. An obstacle to ECP use is lack of knowledge due to lack of Food and Drug Administration approval of Ovral and Danazol and physician concern for legal liability. Another obstacle consists in the logistics of obtaining ECPs and the fear of side effects. Provision of ECP kits with 3-5 regimens in clinic or physician offices is proposed for women without contraindications. Anticipated objections are reported to be encouragement of contraceptive risk taking, the health risks of repeated use, restrictions in Title X programs, and the drug effect on fertilization. Another proposal is to sell ECPs as over the counter drugs or in vending machines and changing US contraceptive prescription laws. Objections to elimination of the physician prescription requirement might be an increase in use among women with contraindications and a decrease in regular checkups and Pap tests. The objections could be overcome with proper package labeling. Paternalism is not a sufficient justification for requiring prescription of contraceptives and medical visits. ECPs, in fact, are already available as low dose contraceptives such as Lo/Ovral, Nordette, Levlen, Triphasil, and Tri-Levlen when 4 pills are used. Instructions for ECP use are given.
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PMID:Emergency contraceptive pills: a simple proposal to reduce unintended pregnancies. 148 31

Estrogens, gestagens, or estrogen-gestagen combinations can be employed as postcoital oral contraceptives. High dose estrogens, such as 5 mg of ethinyl estradiol (EE) daily for 5 days started at the latest 72 hours after unprotected coitus have been proved quite effective with a failure rate of about 1%. However, in about half of the women nausea and in one=third vomiting occurred. Among gestagens the highly effective 19=testosterone preparations are notable. Most experiences pertain to norgestrel (Razemat) as well as to the twice as effective levonorgestrel (D-(-)-norgestrel) LNG. After unprotected coitus, 0.6 mg of LNG taken within 12 hours but possibly even after 1-3 hours is effective. It is common to use a combination of 0.25 mg of LNG and 0/05 mg of EE (Tetragynon). 2 tablets are taken within 48 hours after unprotected intercourse and 2 more 24 hours later. In 4 large studies in Canada and the US with a total of 1540 women who were given instead of LNG the double dose of the half so effective Razemat, the pregnancy rate was 0.9% (14 pregnancies) and the corrected failure rate was 0.65% after excluding women with several unprotected exposures. Assuming a probability of pregnancy of up to 30% after unprotected intercourse depending on the day of the menstrual cycle, the action of the gestagen=estrogen preparation can be regarded as reliable. The side effects are less frequent compared with the high-dose EE therapy. In an Austrian study of 50 women taking Tetragynon, 11 women had nausea, 2 had breast tension, and 4 had vomiting. The duration of bleeding lasted an average of 2 days longer after the taking the pill. 2 women who vomited 2 hours after taking the 1st Tetragynon dose became pregnant. Therefore, in case of nausea it is recommended that an antiemetic be given, and in case of vomiting, the 1st dose of Tetragynon has to be repeated to assure an effective action.
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PMID:[The postcoital pill]. 150 66

Research in the area of oral contraception currently focuses on the development of selective progestogens that combine targeted progestational and antiovulatory activity with a minimal potential for androgenicity. The present dual-center study was conducted to investigate the efficacy, tolerability, and safety of a new monophasic oral contraceptive (OC) which contains 250 mcg norgestimate in combination with 35 mcg ethinyl estradiol (EE; Ortho-Cyclen or Cilest). 97 healthy women of childbearing age were part of this study; 37 received the new norgestimate/EE combination OC as primary therapy and 31 were switched over from the other OCs. The formulation was well-tolerated and was associated with excellent cycle control. After 6 cycles of use, there was no statistically significant difference in the incidence of spotting or breakthrough bleeding as compared with the baseline. Nor were there any significant changes in the incidence of headache, nausea, or mastalgia. Body weights remained constant for the duration of the study as did systolic and diastolic blood pressures. Of particular interest was the absence of any statistically significant alterations in metabolic parameters, including blood glucose or lipoprotein levels. These findings are consistent with the results of several other European studies and indicate that the norgestimate/EE combination OC combines superior cycle with minimal risk of androgenic side effects.
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PMID:Clinical experience with a new norgestimate-containing oral contraceptive. 167 78

Health workers took blood samples from 41 black women living in the greater Harare area of Zimbabwe before they began taking a combines oral contraceptive (OC) with 30 mcg ethinyl estradiol and 150 mg desogestrel (Marvelon formulation) and 3, 6, 9, and 12 months after taking it to conduct metabolic tests. They also recruited 190 other black women from Harare and rural Chiweshe, Mazowe, and Domboshawa populations taking the same new generation progestogen-containing OC to determine the efficacy, acceptability, and safety of the OC. Only high density lipid (HDL) cholesterol levels rose considerably between pretreatment and 12 months (0.94-1.3 mmol/ml; p.05). Low density lipid (LDL) cholesterol levels remained basically the same. This accounted for the significant rise of the HDL cholesterol/LDL cholesterol ratio over 12 months from 0.41 to 0.61. Triglyceride levels did not rise significantly and always stayed within the normal range. No woman became pregnant during the clinical trial. 2% experienced minor side effects including backache, spotting, headache, and nausea. Body weight and blood pressure did not change significantly. Sociodemographic reasons accounted for the high dropout rate (60%). The leading reason was change of address since many women were migrant farm workers. Since HDL levels rose and LDL levels were the same, this OC appears to have a reduced risk of atherosclerosis and cardiovascular disease. The findings indicated that the Marvelon formulation OC did not adversely affect lipid metabolism and therefore did not increase the risk of atherosclerosis or cardiovascular disease among these women. It also effectively protected them from pregnancy and induced minimal side effects.
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PMID:Evaluation of a combined oral contraceptive pill in black Zimbabwean women. 180 54


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