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2 cases reports are described of patients with renal artery stenosis who presented with hypertensive encephalopathy, normal blood pressures having been recorded within the previous 6 months while taking oral contraceptives (OCs). A 27-year-old woman, admitted to the hospital following 2 grand mal fits, had suffered from increasing headaches, nausea, and vomiting over the previous month. Her blood pressure had been elevated at 160/110 mmHg 1 week prior to admission but had been normal over previous 11 years while taking OCs (various formulations of combined estrogen and progestogen) which she had stopped taking 2 months previously. She was a nonsmoker. Her blood pressure was controlled with atenolol, nifedipine, and bendrofluazide, and her conscious level returned to normal with no further fits. An intravenous urogram revealed a small left kidney with a delayed nephrogram, and subsequent arteriography showed bilateral medial fibromuscular dysplasia with a narrow stenosis of the left renal artery. Attempted balloon angioplasty was unsuccessful due to arterial spasm. 4 months after presentation she became pregnant. Blood pressure was controlled with methyl dopa during pregnancy which progressed uneventfully to full term. In the 2nd case, a 19-year old girl became confused and suffered a grand mal convulsion. She had complained of headaches over the previous 3 days. Her blood pressure had been normal over the previous 6 months while taking Logynon (phased formulation of ethinylestradiol and levonorgestrel). She was a nonsmoker. On admission to the hospital, she suffered further generalized convulsions. Despite control of her convulsions with intravenous chlormethiazole, her blood pressure rose to 220/140 mmHg, and this was controlled with intravenous hydralazine and propranolol. The following day she was conscious and was changed to oral therapy. A renogram and DMSA scan showed normal sized kidneys, but there was evidence of decreased blood flow to the left kidney with an increased transit time. Renal arteriography showed a stenosis of the left renal artery, typical of intimal fibromuscular dysplasia, which was dilated by balloon angioplasty. Anti-hypertensive medication was withdrawn postoperatively, and her blood pressure has remained well controlled. In both of the cases the onset of hypertension was rapid with encephalopathy being the presenting feature. Hypertensive encephalopathy is well recognized as a presenting feature of renal transplant artery stenosis but not in cases of native renal artery stenosis. 1 of the patients had stopped using OCs 2 months before presentation, suggesting that although there may have been an association between OC use and the development of fibromuscular dysplasia, it could not be implicated in the mode of presentation.
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PMID:Encephalopathy in renovascular hypertension associated with the use of oral contraceptives. 311 27

A comparative study of Norinyl 1/35 and Brevicon was conducted at the APLAFA clinic in Panama City, Panama. The study sought to evaluate the differences in continuation rates and the frequency of selected side effects which might contribute to method discontinuation. The 300 subjects were randomly allocated to one of the two oral contraceptives. Women in the Brevicon group reported significantly more (p less than 0.05) intermenstrual bleeding, nausea, headaches, dizziness and vaginal discharge than women in the Norinyl 1/35 group. The total discontinuation rate at 12 months was 28.0 for the Norinyl 1/35 group and 46.7 for the Brevicon group, and this difference was significant (p less than .01). Also, significantly more women (p less than .01) in the Brevicon group discontinued for menstrual problems than women in the Norinyl 1/35 group. No pregnancies were reported during this study. While both oral contraceptives appear safe and effective, Norinyl 1/35 was more acceptable to this group of Panamanian women.
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PMID:A comparative study of Norinyl 1/35 versus Brevicon in Panama City, Panama. 344 38

To collect data on clinical and laboratory effects of the oral contraceptives (OCs) marketed in Hungary, a prospective study was initiated in January 1983. Patient data were collected in regular intervals using standard statistical forms. During the first 2 years of the study, data were collected on 1256 women. A complete segment of the data was selected to be reported in this paper and included 1844 cycles of 121 women using a biphasic OC compared to 1940 cycles of 142 women using a classical formulation pill. The biphasic preparation was characterized by a very low levonorgestrel content with an average ethinyl estradiol dose; the reference preparation was a relatively high dose classical OC. No biologically significant difference was found between hormone and receptor levels. The basis of the comparison of the 2 preparations was the termination of OC use in the 2 groups as a function of time. The primary reasons for stopping administration of these preparations were unwanted pregnancy, medical reasons, critical age above 35, planned pregnancy, and other personal reasons. The difference between the 2 groups proved significant according to the life table method only in the category of medical reasons. Slightly more patients were lost to followup in the higher dose group. In the category of medical reasons, digestive tract complaints like nausea, vomiting, menstrual bleeding anomalies, too frequent bleeding-spotting, episodes of amenorrhea, weight gain, psychic disturbances, headache, breast tenderness, and swelling were prominent. These symptoms were most frequent in the first 3-4 months of OC use. The difference was due to the significantly higher rate of amenorrhea/hypomenorrhea, weight gain, and headache in the high dose monophasic pill group. The biphasic pill group was characterized by a slightly higher rate of gastrointestinal complaints and breast swelling. The overall difference favored the latter preparation. The biphasic OC did not cause a thrombotic change in homeostasis despite the fact that it was estrogen dominated. The basal levels of luteinizing hormone and follicle stimulating hormone were less affected in the biphasic OC users compared to the classical formulation OC users. Estradiol levels did not change significantly. The inhibition of ovulation was about the same with both treatment regimens.
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PMID:Clinical and endocrine effects of long-term hormonal contraception. 358 64

Triphasil, a low-dose combination oral contraceptive containing levonorgestrel and ethinyl estradiol, was tested in four Planned Parenthood clinics on 317 women between 18 and 34 years of age (mean, 23) for a total of 4,692 cycles, or 361 woman-years of usage. Approximately half these volunteers (165) were nulligravidas, and 309 (97.5%) were white. Despite instructions on proper tablet usage, there were 416 cycles (8.9%) in which one or more tablets were missed. Only one pregnancy occurred, in a cycle in which a total of four tablets was missed, for an uncorrected Pearl index of 0.28 pregnancies per 100 woman-years of usage. No pregnancy resulted from method failure, indicating a 100% efficacy rate for Triphasil when taken properly. The mean length of the menstrual cycle with Triphasil was 27.9 days; the mean length of menses, 4.4 days; and the mean latency period, 2.1 days. Menstrual flow was average in 64.1% of the subjects, light in 34.1%, heavy in 1.3% and variable in 0.5%. Amenorrhea during the tablet-free interval occurred in only 0.6% of the 4,692 cycles in which Triphasil was used. Breakthrough bleeding occurred in 6.9% of first cycles and 3.2% of total cycles; spotting, in 10.7% of first cycles and 4.4% of total cycles. Other symptoms that occurred with an incidence of greater than or equal to 1% were acne (1.0%), appetite increase (1.2%), breast discomfort (2.8%), breast enlargement (1.3%), gastrointestinal symptoms (1.7%), simple headache (1.4%) and nausea (1.1%). A total of 44 women (13.9%) discontinued treatment for medical reasons.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Planned Parenthood experience with triphasil. 365 99

At the Institute of Scientific Investigation of Juarez University of Durango State in Mexico, clinical researchers compared three delivery systems of norethisterone (NET) contraceptive microspheres (biodegradable polymers [e.g., polyglycolic or polylactic acid] containing micronized crystals of NET). In the 6-month system, they injected 800 mg of microspheres containing 200 mg NET intramuscularly into 19 women and then monitored the women for various effects and side effects. Soon after injection, the mean NET level in serum rose to a peak value of about 3 ng/ml and then fell gradually until it was below 0.5 ng/ml at 25 weeks. No pregnancies occurred during this period. Estradiol levels remained well below 100 pg/ml, suggesting inhibition of follicular activity. However, one patient showed an elevation in estradiol at week 16. By 24 weeks, 4 of the 19 women showed signs of the return of follicular activity. Rises in progesterone levels, indicative of ovulation, were not seen in most women during the 6-month period. However, 4 women showed progesterone peaks followed by menstruation in weeks 4, 7, 17, and 23, suggesting that their cycles had begun to return before the end of the 6-month period. 35% of women reported dizziness and nausea. 26% reported nausea. A more serious concern was the disruption seen in the menstrual pattern. 13 women had bleeding and spotting, which continued for 8-30 days in 8 women. In the 3-month system, microspheres containing either 75 or 100 mg NET were injected, each into 5 women. NET levels rose to between 1 and 2 ng/ml and fell to 0.5 ng/ml by week 15. At week 25, they were undetectable. Levels of estradiol remained low for at least 15 weeks as did serum progesterone. No pregnancies occurred. One woman ovulated in week 17. Although no headache, dizziness, and nausea were reported, many of the same disruptions in the menstrual cycle reported in the 6-month study were observed, particularly prolonged cycles, amenorrhea, and spotting. Based on these findings, the researchers deemed the 100 mg for 3 months to be the most safe and effective formulation.
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PMID:Norethisterone contraceptive microspheres. 369 1

At this time 3 triphasics are widely used in the US: Ortho-Novum 7/7/7, Tri-Norinyl, and Triphasil. Ethinyl estradiol is the preferred estrogenic agent for the triphasic products. Torethindrone and levonorgestrel were chosen as the progestins for the triphasic products. It is the combined effects of estrogen and progestin in the triphasics that provide their contraceptive action. Triphasil increases both the estrogen and the progestin at midcycle; Tri-Norinyl and Ortho-Novum 7/7/7 elevate the progestin only. The midcycle surges of estrogen and luteinizing hormone are dampened, and ovulation is inhibited. The triphasics represent a 98.7% reduction in total steroid content since oral contraceptives (OCs) were introduced. An estrogen dose of 30-50 mcg will inhibit ovulation, and side effects with such a dose are considered tolerable. The triphasic OCs are in this range. An estrogen dose of 20 mcg has been tested but is slightly less effective and is not recommended. Contraceptive failures have occurred with the triphasic products. In 1486 women studied, 6 pregnancies have occurred. Of these failures, one may have been because of a drug interaction with a barbituate. 1 pregnancy was due to patient failure; 3 consecutive pills were missed. Only 2 pregnancies were certain drug failures. Because of the gentle suppression of ovarian function, it has been observed that the menstrual flow is less affected than by standard OCs. Due to the fact that less total steroid is delivered and more endometrial shedding occurs, it is hoped that the triphasic preparations will have less of a "lingering" effect on the return to functional fertility. Most of the published data on side effects is available from the UK, North America, and Europe on the formulation known in the US as Triphasil. Nausea, vomiting, breakthrough bleeding, weight gain, and breast tenderness appear to be the most common side effects. The major medical reasons for triphasic discontinuation include breast tenderness, weight gain, breakthrough bleeding, nausea and vomiting, headache, and increased bleeding during the 1 week of withdrawal. Rifampin and phenobarbital are examples of drugs found to decrease pill efficiency, including triphasics. Also, a triphasic may interfere with the action of another drug. The new triphasics are appropriate when starting new patients on OCs. Patient counseling is essential. Due to the low margin of error as a consequence of lesser suppression of ovarian function, the patient needs to be well instructed in how to take the pill and advised of the consequences of missed tables.
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PMID:The triphasics: insights for effective clinical use. 382 67

Drug companies have been at work throughout the 1960s, 1970s, and 1980s trying to reduce the steroid content of their oral contraceptives (OCs). Researchers have been successful in reducing steroid content while maintaining effectiveness, thereby making OCs safer. In the 1st half of the natural menstrual cycle, a woman secretes estrogen as the dominant steroid product. In the 2nd half, estrogen is the principal reproductive hormone. Estrogens inhibit ovulation, possibly by inhibiting implantation, altering ovum transplant, or in some way preventing corpus luteum function, which is necessary to maintain early pregnancies and the endometrium. There are still only 2 estrogens and 6 progestins on the market today. They are probably the most thoroughly studied chemical ever seen in the history of pharmacy or medicine. 1 of the estrogens, mestranol, is really a drug of the past. In the body, mestranol is converted to ethinyl estradiol, the other estrogen on the market. Consequently, there is no reason to use mestranol itself. Within the dose range of 50-100 mcg, there's little difference in contraceptive effect. Progestins are the other active ingredient in the combination OC. Their principal action is the thickening of the cervical mucus, which prevents sperm penetration. Also, with sufficient progesterone, ovulation is inhibited, but this happens in only 40% of those patients taking, for instance, the "mini-pill" (which consists of progesterone only). The progestins and the estrogens work in concert to make OCs a highly effective contraceptive method. Recent surveys conducted by the Centers for Disease Control and National Cancer Institute looked into the relative effectiveness of OCs. Nordette had a use effectiveness failure rate of 3.5; Ovral, 3.6. Loestrin 1/20 -- norethindrone acetate, 1 mg, and estinyl estradiol, 20 mcg -- shows a failure rate of 4.5. This indicates that the threshold for an effective dose of estinyl estradiol in OCs is 30 mcg. For 1 mini-pill, Ovrette, the failure rate is 9.5 -- much higher. Depo-Provera has a failure rate of 0.7. The primary complaint from women taking OCs is spotting and breakthrough bleeding during the cycle. 30-50% of women given OCs stop taking them within a year. OC side effects include nausea, fluid retention, breast tenderness, leukorrhea, hypomenorrhea, headaches, spotting around the face, hypertension, and visual changes. 1 of the risks of birth control pills may be cervical dysplasia -- changes in the cells of the cervix. The relative risk of cervical cancer with OCs after 5-9 years is approximately 1.8. Clinical cases of deep vein thrombosis number 1/1000 per year among nonusers of OCs. Among users, the rate is 3 times as high: 3/1000. The most serious potential adverse effect is myocardial infarction. Of the excess deaths attributed to OCs (23.3 total per 100,000 users), 22.7 are due to myocardial infarctions and hemorrhage. The discussion also briefly reviews other methods of contraception -- Depo-Provera, male contraceptives, implants, the diapragm, and IUDs.
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PMID:Prescription contraceptives: countering the risks. 405 Jun 70

490 women who used Stediril (.5 mg norgestrel and .05 mg ethinyl estradiol, combined) for a total of 5600 cycles or 466 woman-years over a 3 year period are presented. They all took the pills primairly for contraception; most were 20-30 years old, and took Stediril 3-6 months. Some other indications were 119 cases of menstrual irregularity, 15 of spaniomenorrhea, 14 of premenstrual syndrome and 3 of acne, all relieved. 46 of 50 cases of menorrhagia, 83 of 89 of dysmenorrhea and 32 of 34 with pelvic pain were relieved. Withdrawal bleeding was usually less than before and tended to diminish with time. There were 46 women with nausea, 3 of whom stopped Stediril. Migraines sometimes a ppeared, sometimes disappeared, but often occurred regularly on the first day between pill cycles. 52 women complained of breast congestion for the first time. Weight rose in 2301, fell in 98 and stayed constant in 134 after 3 months: weight was easily controlled with diet and appetite supressant drugs. No hypertension was observed. There were 19 single cycles of amenorrhea, several cases of persistant amenorrhea and 4 cases of amenorrhea after stopping. 2-3% of cycles were marked by metrorrhagia; 63 women had spotting, 8 had significant metrorrhagia; 7 had metrorrhagia followed by withdrawal bleeding in that cycle. 1 woman had a thromboembolism of the left leg after 2 pill cycles during which she gained 3 kg. There was 1 pregnancy due to irregular pill use.
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PMID:[Clinical study of an estro-progestative association in low doses. Experience of 3 years (490 patients-5600 cycles)]. 426 90

The efficacy, side effects, and biologic actions of the progestogen-only minipills marketed since February 1973 are reviewed. The preparations are: 350 mcg norethisterone (Micronor Ortho), 30 mcg d-norgestrel (Microlut Schering and Microval Wyeth), and 500 mcg lynestrenol (Exluton Organon). The efficacy of these drugs depends on motivation: Pearl indexes vary from 1.17-3.72 for norethisterone, .9-4.4 for d-norgestrel, and .8- 2.2 for lynestrenol. Some physiologic effects of minipills possibly related to their mode of action are impermeable cervical mucus and low levels of progesterone, pregnanediol, estrogen, and LH. The side effects influencing dropout most are spotting (40-55% in the first cycle), polymenorrhea (about 10%), and amenorrhea (about 5-10%). Some transient estrogenic side effects such as nausea, headaches, and breast pain may be due to estrogenic metabolites from lynestrenol and norethisterone. None of the severe estrogenic side effects, such as thrombophlebitis and impaired glucose tolerance and liver function, are characteristic of progestogen pills.
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PMID:[Minipill as the new contraceptive method]. 481 42

203 women 19-40 years of age were administered the gestagen preparations Volidan, Cyclofarlutal, Ovulen, Ciba AC-101, and Stediril as a contraceptive. 49 other women were administered these preparations as therapeutic and/or diagnostic measures in different gynecological complications. Side effects such as spotting, acylic bleeding, nausea, headaches and breast swelling were more frequent with the high-dose preparations such as Volidan and Cyclofarlutal. Intolerance to the preparation and subsequent discontinuation occurred only in a small percentage of the users. All of the preparations achieved 100% effectiveness as contraceptives. It is noted that these preparations were used with some success in treating dysmenorrhea, menometrorrhagia because of hyperplasia of the endometrium, and in severe climacteric syndromes. It has also been used as a pregnancy test. Constant medical control of the administration of these preparations is necessary both when they are used as contraceptives and as therapeutic measures, particularly in the case of young women.
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PMID:[Clinical aspects of the administration of gestagen preparations (Volidan, Cyclofarlutal, Ovulen, Ciba AC-101 and Steridil)]. 545 44


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