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Japan began oral contraceptive (OC) clinical studies after 1987 when the government requested studies of 2400 menstrual cycles and a minimum of 100 patients for 12 cycles and 20-30 patients for 24 cycles. 3 monophasic, 1 biphasic, and 4 triphasic drugs were tested from 6 companies and all contained ethinyl estradiol with different progestins (norethindrone, levonorgestrel, or desogestrel). In phase I, the purpose was to examine the pharmacological effects and shortterm safety of all 8 drugs among a small number of healthy volunteers and a comparison of results with Western women. Phase II was eliminated. Phase III involved examination of toleration of the drug, dropout rate, effects on cycle control such as bleeding patterns, metabolism, and effects on hormone secretion. In phase I, Ortho Novum 7/7/7 was administered at 3 dose levels for 1 menstrual cycle and the results were toleration and minimal side effects. Some experienced bleeding, spotting, and breakthrough bleeding. Suppression of ovulation was successful. In phase III, 40 medical schools, 174 hospitals, and 200 investigators enrolled 648 patients of which 117 withdrew. Interim results among women 22-42 years show no adverse effects either in self- reports or laboratory tests. There were nuisance side effects such as nausea, weight gain, and headache, and some amenorrhea and bleeding during different cycles. There is a high continuation rate and patient satisfaction. Results from the full sample are still pending.
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PMID:The current status of oral contraceptive clinical development in Japan. 257 51

A brief review on how the combined oral contraceptive Ovral is used, without official US FDA approval, as a postcoital contraceptive is presented. The pill contains 50 mcg ethinyl estradiol and 0.5 mg norgestrel. Presumably the estrogen prevents implantation. The recommended dosage is 2 tablets taken 12 hours apart, preferably within 12-24 hours, and no later that 72 hours, after intercourse. Compared to a likelihood of pregnancy, in the event of unprotected intercourse, of 20% 3 days before ovulation, 25% 1 day before ovulation, and 15% on the day of ovulation, Ovral has been reported to prevent all by 1.8% of pregnancies. The highest failure rate cited was 7.4%. The only adverse effects noted were nausea, vomiting and breast tenderness. No fetal malformations have been published with this regimen.
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PMID:Ovral as a "morning-after" contraceptive. 279 42

2 cases of thromboembolism in young women with no risk factors except use of triphasic oral contraceptives are reported. A 21-year old White woman, Gravida I Para I, presented to the emergency room with a painful, blue, mottled right lower leg after pain in the hip and buttock for 1 week. She had taken a triphasic oral contraceptive containing 35 mcg ethinyl estradiol and 0.5, 0.75, 1 mg norethindrone for 1 month, and had no other related history. Doppler and venogram tests showed thrombosis of the ileal, femoral, popliteal and infrapopliteal veins. She was treated with heparin, streptokinase, and urokinase without success and recovered after ileal, femoral and popliteal thrombectomy. The 2nd case was a 30-year-old Gravida III Para I Black woman who had taken a pill containing 50 mcg ethinyl estradiol and 500 mcg norgestrel for 13 years and had recently switched to the triphasic pill described above. She had dull midepigastric pain, nausea, vomiting, diarrhea and chills, for 1 week. Physical exam was negative except for abdominal tenderness and a heart murmur. Abdominal ultrasound revealed portal venous thrombosis extending to the splenic and superior mesenteric veins. She was treated with transhepatic urokinase without effect and celiotomy was performed. She was discharged with an occluded right branch of the portal vein. These cases point out the fact that the estrogen dose in triphasic pills is not lower than that in low dose combined oral contraceptives.
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PMID:Idiopathic thromboembolism associated with triphasic oral contraceptives. 281 53

28 patients with polycystic ovary syndrome were treated for 12 months with the new preparation SH B 209 AE, consisting of 0.035 mg of ethinyl estradiol and 2 mg of cyproterone acetate. This was the first clinical trial of estroprogestational therapy on a homogeneous sample of women with polycystic ovary syndrome. Endocrine findings indicated a significant decrease in all hormonal parameters, the invariableness of prolactinemia, a considerable increase in sex hormone binding globulin (SHBG) at the 6th treatment cycle examination, a continuous significant decrease in 17 beta E2 and androstenedione from the 6th to the 12th treatment cycles. In terms of clinical findings, there was a significant decline in the severity of acne, seborrhea, and hirsutism during drug administration. The menstrual cycle in the 28 study subjects remained under control during treatment, and there were no pregnancies. Side effects such as weight gain, nausea, headache, and changes in libido were not reported. Overall, the findings of this study suggest that administration of the new monophasic contraceptive association SH B 209 AE can normalize endocrine patterns in polycystic ovary syndrome and improve its androgenic symptomatology. The low content of estrogen, the changes in clinical and hormonal parameters, the low incidence of side effects, and the good control of the menstrual cycle provided by this treatment make SH B 209 AE deserving of more widespread application.
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PMID:A new association of ethinylestradiol (0.035 mg) cyproterone acetate (2 mg) in the therapy of polycystic ovary syndrome. 294 60

The efficacy and acceptability of a monophasic oral contraceptive (OC) containing 30 mcg of ethinyl estradiol and 150 mcg of desogestrel were evaluated in a clinical trial involving 1613 women at 47 centers in 11 countries. A total of 23,258 menstrual cycles were available for analysis. Although or more tablets were forgotten in 892 cycles (3.8%), there was only 1 pregnancy due to patient failure in this study and no pregnancies attributable to method failure. Cycle control was good and comparable to that reported for other low-dose OCs. In 90% of the cycles, the withdrawal bleed started 1-4 days after intake of the last pill and lasted 5 days or less. The incidence of breakthrough bleeding and spotting decreased with duration of pill use. After 24 cycles, the discontinuation rate because of bleeding problems was only 6%. The discontinuation rate for minor side effects was 4% after 24 cycles; these side effects included nausea, headache, nervousness, and breast tension. After 24 cycles, body weight was not affected in 70% of the participating women, 18% reported a weight increase of greater than 2 kg, and 12% experienced a weight decrease of over 2 kg. Most of the women who reported a weight gain were under 20 years of age. The ethinyl estradiol-desogestrel combination had no effect on average blood pressure. Previous research has shown desogestrel to have unique advantages as the progestogen component of combined OCs in that it does not counteract the ethinyl estradiol-induced increase in high-density lipoprotein. This, together with the good reliability and acceptability recorded in the present study, suggests that the monophasic desogestrel OC should be prescribed on a widespread basis.
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PMID:Multicenter trial of a monophasic oral contraceptive containing ethinyl estradiol and desogestrel. 297 60

Mechanism of action, indications, side effects and contraindications of oral contraceptive agents (OCA) are reviewed. OCA can be divided into two groups: consecutive and combined agents. Combined OCA contain both estrogens and gestagens and are taken for 3 weeks, while consecutive OCA contain only estrogens and are taken for 2 weeks followed by 1 week of combined OCA until the onset of menstruation. Biological activity of synthetic gestagens is estimated by a dosage which results in a delay of menstruation by 2 weeks. Gestagens norethindrone and norethynodrel were shown to be equally effective, while ethinodiol diacetate and norgestrel were 15-30 times more effective. Estrogen component of OCA is represented by ethinyl estradiol or mestranol. Combined OCA are more effective than consecutive OCA; probability of undesirable pregnancy during administration of combined OCA does not exceed 0.2%. The most frequent side-effects of OCA include nausea, headache, uterine hemorrhage, and changes in libido. OCA can affect the endocrine and reproductive systems. Major endocrine effects of OCA include changes in the cortisol metabolism in the adrenal glands, increase in the level of thyroid-binding globulin in the thyroid gland, changes in the glucose metabolism in the pancreas, inhibition of the luteinizing hormone releasing hormone in the hypothalamus with simultaneous decrease in the production of pituitary gonadotropins and inhibition of the ovulation. The most serious side-effects of OCA include cholelithiasis, thrombophlebitis, thromboembolism, liver adenoma, and myocardial infarction. Absolute contraindications to the use of OCA include hypertension, hyperlipidemia, breast or endometrial cancer, pregnancy, cardio-vascular diseases, liver diseases, and kidney insufficiency.
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PMID:[Principles of the use of oral contraceptive preparations]. 307 80

To evaluate the safety and effectiveness of Minulet, a new low-dose combination oral contraceptive (OC) containing 75 mcg of gestodene and 30 mcg of ethinyl estradiol, a multicenter trial involving 239 women was conducted in Switzerland. Of the 239 subjects, 187 (78%) were monitored for 6 cycles of OC use and 24 (10%) were followed for 3 cycles, yielding a total of 1265 cycles for observation. No pregnancy occurred during the study period, despite the fact that 1 or more pills had been forgotten in 17.1% of cases. Cycle length and the intensity and duration of bleeding were favorably affected by Minulet use, especially in women with a prior history of prolonged, heavy bleeding. Spotting occurred in 8.2% of subjects by cycle 3, but this rate was reduced to 5.9% by cycle 6. Breakthrough bleeding alone occurred in 2.1% of the cycles. The amenorrhea rate was 1.6% after cycle 6. There were no serious side effects, and symptoms such as headache, depression, breast tenderness, acne, nervousness, and dizziness were actually reduced as a result of OC use. Most notable was the decrease in dysmenorrhea, from 40% before beginning OC use to 13% after 3 months and 8% after 6 months. No significant effects on systolic or diastolic blood pressure were recorded among study participants, nor were there significant weight changes. Of the 17 women who terminated the trial due to side effects, metrorrhagia accounted for 17% of the terminations, depression for 14%, nausea for 14%, and headache for 13%. The findings of this trial, in terms of reliability, cycle control, and tolerability, suggest that Minulet has considerable potential as a new contraceptive choice.
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PMID:Clinical experience in Switzerland with the new monophasic oral contraceptive Minulet (75 mcg gestodene, 30 mcg ethinyl oestradiol). 307 5

Detailed interview information was obtained from 515 women in connection with a Swedish-Norwegian comparative investigation on possible connections between use of oral contraceptives (OCs) and premenopausal breast cancer. The Norwegian data was reviewed to ascertain the occurrence of mild side effects and how these side effects influence the use of OCs. In all, 63% of those interviewed had used OCs. Side effects were reported in 55.6% of the 629 use periods. The most frequent side effects were weight gain (17.8%), irregular menses (14.0%), nausea (8.9%) and tender breasts (8.8%). The respondents also reported depression, aggressiveness, decreased libido, headache and migraine. Differences in side effects were found for various OCs depending upon quantity of hormone and composition. Estrogen related complaints such as tender breasts and weight gain increased in relation to the estrogen dosage in the pill. Users of the minipills often reported irregular menses. Reports of psychological problems were relatively evenly distributed but users of minipills reported significantly lower rates of side effects for such complaints. Although relatively few use periods were reported for triphasic pills, these also appear to be involved with a number of side effects. 2 out of 5 women who began taking OCs reported that they had to stop because of side effects. This reduced the value of OCs as an effective and easily obtainable means of contraception.
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PMID:[Mild side-effects of oral contraceptives]. 320 63

Confirmation of a causal relationship between hemolytic-uremic syndrome (HUS) and verotoxin-producing Escherichia coli (VTEC) infection is provided by the case of a 22-year-old West German woman. The patient presented with fatigue, nausea, and headache. Ultrasonography revealed enlarged kidneys, and laboratory investigations showed uremia, hemolytic anemia, lactate dehydrogenase, haptoglobin below the detection limit, and thrombocytopenia. She received hemodialysis and drug treatment (heparin, dopamine, and furosemide). To investigate the kinetics of the humoral response to verotoxin, the patient was followed for 3 months. Fecal specimens on day 23 yielded E coli serotype 0111:NM, and stool filtrates on days 16 and 23 showed highly cytotoxic activity for HeLa cells. While the patient's initial serum showed a high IgM immune response against purified Shiga toxin, there was a steady decline in IgM and steady increase in IgG antibodies over the ensuing 3 months. These findings are suggestive of a recent infection by a verotoxin-producing organism. This is the 1st reported case of VTEC-associated HUS with e coli 0111 infection in an adult, and the patient's 4-year history of oral contraceptives (OCs)--ethinyl estradiol and chlormadinoneacetate--is considered to be of etiologic significance. The diminished antibody coating of bacteria in the urinary tract of OC users may have facilitated invasion of verotoxin across the mucosal barrier in this patient. Severe hypertension has been reported previously in OC users with HUS. It is speculated that verotoxin may trigger HUS in longterm OC users, initiating vasoconstriction and microangiopathic hemolysis.
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PMID:Hemolytic-uremic syndrome associated with an infection by verotoxin producing Escherichia coli 0111 in a woman on oral contraceptives. 328 32

294 women between 18 and 35 years of age -- without absolute contraindications to estrogen use, with regular menses, who had had intercourse from 3 days before to 2 days after presumptive ovulation -- were given ethinyl estradiol (EE) in dosages of 5 mg/day and domperidon 20 ng twice/day for 5 days between and 72 hours from intercourse. Follow-up visits 30 days later showed that only 243 women had adhered to the protocol. It was calculated that 32.9 pregnancies were statistically probable in the absence of therapy in the study group; none actually occurred. Even among the 27 women who presented not having followed the therapeutic protocol correctly, there were no pregnancies. Side-effects such as vomiting, nausea and breast tenderness occurred in 54% of the patients, even though domperidon is an efficacious anti-emetic.
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PMID:[Use of estrogens in post-coital contraception. Our case material of 243 cases]. 337 30


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