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Highlights of papers presented at an international symposium on advantages and risks of oral contraceptives, and the details of the results of 2 studies are discussed. 1 study compared the effects of a combination of 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel with a reduced dose 3-phase combination of these hormones; it involved 489 women with 2777 menstrual cycles for a 6-month period. No pregnancies occurred. Missed menstruation occurred in 0.9% of the cycles with the 3-phase combination, contrasted with 2.3% of the 30/150 mcg combination group. Bleeding disorders were more frequent in the 30/150 pill group (15.7% vs. 10.1%). Spotting occurred in 8% of cases in both groups. The 3-phase pills proved to be safe and were preferred because they caused less bleeding. Another study compared the effects of 2 Swedish-made contraceptives by administering Neovletta (N) to 50%, Trionetta (T) to 25%, and Trionetta 28 (T 28) to another 25% of the 862 women with 6472 menstrual cycles who participated at 12 family planning centers in Sweden. T and N contain the same amount of estrogens, but T contains 40% less gestagen than N. The T 28 treatment also included 7 placebo tablets. Results showed that only 1 pregnancy occurred in the T group, despite a high rate of failure to take the pills (8.1-9.4%). Menstruation was normalized in both the N group (90.4%) and the T group (94.2%) reaching the normal 28 (+ or - 2) days cycle. Missed menstruation occurred in 0.6% of the T group as opposed to 2.3% of the N group. There was a significant difference in spotting and irregular bleeding between the 2 groups: 6.3%-15.8% for N and 3.0-9.0% for T. Also, there was a higher rate of bleeding problems for T 28 than for T. 8.6-8.8% of women in both groups quit the experiment because of complications, e.g., bleeding, nausea, headache, and hypertension. Both pills proved to be reliable and safe, but the new 3-phase preparation, T, is recommended because it does not reduce the beneficial HDL cholesterol as does N.
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PMID:[Report from an international symposium about advantages and risks of oral contraceptives. Amsterdam, March 1982]. 692 Nov 98

A review of the composition, usage, and side effects of hormonal contraceptives is presented. The estrogens ethinyl estradiol, mestranol, ethinyl estradiol sulfonate, and quinestrol, as well as the gestagens chlormadinon acetate, norethindrone acetate, and d-norgestrel, are used in combination, sequential, and depot preparations, mini-pills, and morning-after pills. The failure rate of combination preparations is 1/100 women-years and of sequential preparations is 1-5/100 woman-years. Gestagen-intensive preparations can be used for women showing symptoms of gestagen deficiency (e.g. hypermenorrhea, endometriosis), while estrogen-intensive preparations are indicated for women with e.g. hypomenorrhea, acne, or hirsuitism. Preparations containing chlormadinon acetate are indicated for women with signs of androgen imbalance or for women who sing or use their voices professionally. Control check-ups of patients using hormonal contraceptives should occur every 6 months. Women who still want to bear children should discontinue hormonal contraceptive use for a certain period every 2 years. Hormonal contraceptives can be prescribed to adolescents 2 years after menarche and after one year of regular menstruation. The side effects of hormonal contraceptive use are listed. Subjective side effects such as nausea and headaches are frequently reported. Hormonal contraceptives can cause menstrual irregularities; spottings or break-through bleedings during hormonal contraceptive use indicate a reduced contraceptive effectiveness. Hormonal contraceptive use causes increases in laboratory values, e.g. SGOT, SGPT; lipid metabolism and carbohydrate metabolism are also affected by hormonal contraceptives. Hormonal contraceptives have been shown to cause an increase in blood pressure and affect the circulatory system, liver and gall bladder function, and blood coagulation. Neoplasms may be affected positively or negatively by hormonal contraceptive use. Relative and absolute contraindications for hormonal contraceptive use as well as indications for discontinuing hormonal contraceptive use are listed.
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PMID:[Hormonal contraception--side effects and surgical aspects (author's transl)]. 701 44

The study purpose was to obtain additional clinical experience with 200 mcg of ethinyl estradiol combined with 2 mg dl-norgestrel as an emergency postcoital contraceptive. Half the dosage was administered immediately upon entry into the study and the remainder 12 hours later. A total of 28 clinics in Canada agreed to participate in the study, but 4 withdrew before entering any cases. Participants were either health services of educational institutions, Planned Parenthood facilities, or hospital based women's clinics. A 24 month enrollment period was chosen, but the largest numbers of subjects were enrolled during a total of 14 months. A total of 692 subjects were enrolled. The total dosage administered was 200 mcg of ethinyl estradiol and 2 mg of dl-norgestrel. 3 of the 24 participating clinics provided 60.1% of the enrolled cases. 120 of the 692 subjects had been pregnant at least once before. 95 of these were regularly cycling, and 25 were irregularly cycling. Subjects were divided into 2 groups, those having regular menstrual cycles and those with irregular cycles. Regular cycles were defined as no more than +or- 5 days variation in cycle length from cycle to cycle. There were 496 regularly cycling women (71.8%) and 194 (28.0%) with irregular cycles. In 2 cases data were lacking regarding cycle regularity. An almost equal number of study subjects were treated within the 1st 24 hours (42.4%) and the subsequent 24 hours (35.6%) following exposure. A further 20.1% were treated between 48 and 72 hours following exposure. A midcycle exposure (MCE) for regularly cycling subjects was calculated from the average cycle length, minus 14 days +or- 3 days. Of 451 who were regularly cycling and for whom data were available, 101 were exposed prior to midcycle, 217 at midcycle, and 133 after midcycle. 11 pregnancies were reported from 6 of the participating clinics. 4 of these women had been pregnant at least once previously. 9 had regular cycles, and 2 had irregular cycles. 4 of the 9 regularly cycling women reported other unprotected coital exposures more than 72 hours prior to treatment during their treatment cycle. 42.4% of the subjects experienced no side effects. Nausea and/or vomiting occurred in 51.7% of the subjects and was absent in 48.3%. Other side effects were infrequent. the combination of 200 mcg ethinyl estradiol and 2 mg of dl-norgestrel appears to be an effective method of postcoital contraception with failure rates comparable to those reported for the estrogens used alone.
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PMID:A multicenter clinical investigation employing ethinyl estradiol combined with dl-norgestrel as postcoital contraceptive agent. 704 Jan 17

A case is described wherein a 29 year old woman was admitted to the hospital because of the possibility of a hepatic tumor; symptoms included abdominal pain, diffuse hepatic enlargement and absence of uptake in an area of the right hepatic lobe. After a normal pregnancy and delivery 11 years earlier the patient used oral contraceptives (OCs) composed of norethindrone with mestranol until 8 years before entry; 5 years before admission she resumed use of an OC containing norethindrone and ethinyl estradiol. She smoked 1.5 packages of cigarettes and drank 1 glass of wine daily, and there was no history of nausea, vomiting, melena, jaundice, dark urine, light stools, hepatitis, or blood transfusions. Benign lesions which are known to be caused by OCs fall into 2 groups: designated focal nodular hyperplasia and liver-cell adenoma. The evidence linking the latter with OCs is more convincing since in case-controlled studies the risk of development of adenomas has been shown to increase with the estrogen strength of the OCs and duration of use; in women who have been taking OCs over 7 years the relative risk is 500 times that for matched control nonusers. The vascular complications of OC therapy include Budd-Chiari syndrome, peliosis hepatis, and periportal sinusoidal dilatation. The patient in this case was diagnosed to have periportal and midzonal hepatic sinusoidal dilatation association with OC medication. She underwent an operation on her liver which proved to be successful combined with cessation of OC use. The mechanism by which OCs cause these lesions is not known. In 5 of 13 cases similar to the one described here clinical and biochemical abnormalities resolved and 1 patient had a follow-up liver biopsy that revealed normal findings 10 months after cessation of OC therapy; there is no evidence to suggest that sinusoidal dilatation is irreversible.
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PMID:Case records of the Massachusetts General Hospital. Weekly clinicopathological exercises. Case 40-1982. Tender hepatomegaly in a 29-year-old woman. 711 Feb 74

Although oral contraceptives (OCs) are yet to be legalized in Japan, it is estimated that at least 500,000 women were on pills in 1975. Intrahepatic cholestasis has been associated with OC in the Western countries, but only a few cases have been reported in Japan. A case of pill-related intrahepatic cholestasis in a 25-year old housewife will be presented in terms of clinical/pathological findings, changes in plasma and bile acid levels, and the effect of phenobarbital on bile stagnation. The patient had been taking 1 pill (Anovlar)/day, 25 days a month, for 5 months, and had experienced exhaustion, nausea, and constipation after 3 months of use; body itch and jaundice symptoms after 4 months. Cholangiography showed neither enlargement of the bile duct nor obstruction of the bile duct outside the liver. The condition was diagnosed as pill-related intrahepatic cholestasis. Total bilirubin was considerably raised; serum transaminase was moderately raised. Electromicroscopy showed the enlargement of bile canaliculi, which had electron dense bile content. Hepatic cellular peroxisome significantly increased. Plasma bile acid level, which was slightly raised initially, came down to the normal range when total bilirubin was back to normal with daily administration of phenobarbital 2 mg/kg. Studies which included experiments with rats as well as clinical-pathological results mentioned above suggested that bile stagnation was caused by ethinyl estradiol. By lowering bile canaliculi Na-K ATPase activity, ethinyl estradiol decreased bile acid independent of bile flow. Phenobarbital was effective for cholestasis by increasing bile canaliculi Na-K ATPase activity.
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PMID:[Intrahepatic cholestasis caused by oral contraceptives]. 714 55

In a randomized study, 63 postmenopausal patients with advanced breast cancer were treated with ethinyl estradiol (EE2) or the antiestrogen tamoxifen to compare the efficacy and side effects of both drugs. EE2 was always given in combination with chlorothiazide to prevent fluid retention. Pretreatment characteristics of the patients of both groups did not differ significantly. Objective remissions were achieved in 31% of the EE2-treated patients and in 33% of the tamoxifen-treated patients. The median duration of remission was 12 months (range, 5-32) for the EE2 group and 11 months (range, 5-26) for the tamoxifen group (P greater than 0.1), and the estimated median survival times from the start of treatment were 31 and 25 months, respectively (P greater than 0.1). The best treatment results in both groups were obtained in patients with estradiol receptor-positive tumors and less advanced disease. After therapy was stopped, objective withdrawal responses were observed in EE2- but not in tamoxifen-treated patients. Two patients receiving EE2 had to discontinue treatment because of drug-related liver function impairment. Both patients had cholelithiasis. Two patients in the tamoxifen-treated group discontinued therapy because of nausea. Deep venous thrombosis occurred in one patient receiving EE2, whereas two patients receiving tamoxifen developed superficial thrombophlebitis. Other side effects in both groups of patients, including initial hypercalcemia, were mild. It is concluded that both treatment regimens, EE2 or tamoxifen, are equally effective with respect to induction and duration of remission in postmenopausal patients with advanced breast cancer. Side effects of EE2 therapy appeared to be more serious than those of tamoxifen treatment.
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PMID:Tamoxifen versus ethinyl estradiol in the treatment of postmenopausal women with advanced breast cancer. 723 48

Cyproterone acetate (100 mg daily on the 5th-14th days of the normal cycle) together with ethinyl estradiol (0.05 mg daily on the 5th-25th days) was used for the treatment of hirsutism in 23 women for six months. This treatment caused a significant decrease in the severity of the hirsutism after only three months, the effect being maximal after six months. Sixty per cent of our patients reported being subjectively satisfied with the results. A relapse occurred, however, within three months of the end of the treatment in half the patients. The serum testosterone was significantly decreased after three months of treatment, but the changes in serum testosterone did not follow the changes in the clinical picture of hirsutism, suggesting that one facet in the favorable action of cyproterone acetate is an inhibition of the action of androgen on target cells. Various side effects, such as nausea, headache, loss of libido and depression, were reported very frequently, which undoubtedly limits the large scale use of this treatment, at least with the doses used in this study.
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PMID:Cyproterone acetate in the treatment of hirsutism. 728 7

A core design contraceptive vaginal ring (CVR) releasing 650 mcg of norethindrone acetate (NA) and 10, 20, 30 or 65 mcg of ethinyl estradiol (EE) daily was developed and tested in 99 women. The CVR inhibited ovulation well with 30 or 65 mcg EE. Vaginal bleeding was better controlled than in 23 control women using NA/EE oral contraceptives. Side effects were comparable to controls for the 20 and 30 mcg EE CVR. The 65 mcg EE CVR resulted in an unacceptably high level of nausea. The 20 and 30 mcg EE CVR caused an increase in serum HDL cholesterol and triglycerides. Total cholesterol was unchanged. Angiotensinogen and sex hormone binding globulin-binding capacity were increased in a subgroup of the 20 and 30 mcg EE CVR subjects, similar to that of 20 controls using EE/gestodene oral contraceptives. This new CVR offers an excellent contraceptive alternative with the best performance provided by the 30 mcg EE dose.
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PMID:A contraceptive vaginal ring releasing norethindrone acetate and ethinyl estradiol. 770 95

A core design contraceptive vaginal ring (CVR) with average daily release of 650 mcg of norethindrone acetate (NA) and 30 mcg of ethinyl estradiol (EE) inhibited ovulation and controlled vaginal bleeding well, but caused some nausea. This study was designed to minimally alter the dose of steroid to see if nausea could be reduced without loss of contraceptive efficacy. This 30/650 CVR was compared to a CVR releasing 20 mcg of EE and 1000 mcg of NA (20/1000) and another releasing 25 mcg of EE and 650 mcg of NA (25/650) in 69 subjects. Twenty-three subjects using an oral contraceptive containing NA/EE served as controls. Ovulation inhibition was excellent and comparable to the OC for all formulations. The CVR provided better control of vaginal bleeding than did the OC. Side effects were equivalent to the OC with the exception of a slight increase in nausea in CVR users. Lipid changes and globulin increases were comparable to oral contraceptive users. The 20/1000 CVR increased sex hormone binding globulin-binding capacity less than the other two CVRs. The performance of the three CVRs was not significantly different, but the 25/650 showed a trend of reduced performance relative to the other two formulations.
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PMID:Dose-finding study of a contraceptive ring releasing norethindrone acetate/ethinyl estradiol. 770 96

Postcoital contraceptives are available for adolescent use in the US. They include combination oral contraceptives (OCs), high dose estrogens, danazol, and IUDs. Mifepristone (RU-486) is currently not available in the US but is used in France, the UK, and Sweden. Postcoital contraception is especially important for adolescents who have a very high pregnancy rate due to poor contraceptive use. Administration of 2-5 mg ethinyl estradiol (EE) for 5 days beginning within 72 hours of unprotected intercourse yields pregnancy rates ranging from 0-0.92%. EE-related side effects include nausea, vomiting, sore breasts, and irregular menstrual bleeding. DES should not be used, since it is associated with reproductive tract anomalies and vaginal cancers in exposed offspring. Conjugated estrogens have not been used in adolescents for postcoital contraception. The Yuzpe regimen consists of 2 tablets of a combined OC with 200 mg EE and 2 mg dl-norgestrel administered within 72 hours of unprotected intercourse followed by the same dose 12 hours later. Common side effects are nausea and vomiting. Its pregnancy rate is 1.8%. Levonorgestrel-containing OCs can also be used. Administration of 800-1200 mg danazol up to 120 hours after unprotected intercourse protects against pregnancy in about 98% of cases. Copper IUDs have a high efficacy rate when used as postcoital contraception (99.9%), but public opinion, medicolegal considerations, financial costs, and potential for infection impede IUD as a postcoital contraceptive in the US. RU-486 is best known as an abortifacient. It is also a potential postcoital contraceptive. Two UK studies find that RU-486 used as a postcoital contraceptive has a very low pregnancy rate and fewer side effects than the Yuzpe regimen and danazol. It is much more costly than currently used postcoital contraceptives (600 mg of RU-486 cost US$ 68, while Ovral costs US$ 0.48-2.24). Nevertheless, RU-486 may replace the higher doses of OCs as a postcoital contraceptive method.
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PMID:Postcoital contraception: present and future options. 774 40


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