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Query: UMLS:C0027497 (nausea)
 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

A comparison of the triphasic Triphasil and the combined oral contraceptive Diane 50 for treatment of acne for 6 cycles showed significant improvement in both groups. Triphasil (Wyeth-Ayerst) contains 50 mcg levonorgestrel and 30 mcg ethinyl estradiol, 75 mcg levonorgestrel and 40 mcg ethinyl estradiol for 5 days and 125 mcg levonorgestrel and 30 mcg ethinyl estradiol for 10 days. Diane 50 (Schering Ag) contains 2 mg cyproterone acetate and 50 mcg ethinyl estradiol for 21 days per cycle. 10 women in each group had physical, pelvic, ophthalmologic and neurologic exams, hematologic and biochemical screens, assays of free testosterone, sex hormone binding globulin (SHBG), androstenedione, dehydroepiandrosterone SO4 (DHEAS), progesterone, and computations of acne and hirsutism scores. Subjects had used tetracyclines, isotretinoin, erythromycin, topical clindamycin and benzoyl peroxide previously, but were withdrawn from medication in the cycle before the intervention. The mean acne scores, derived from grading and counting lesions and comedones, fell from 63.3 to 6 in the Diane 50 and from 64.2 to 4.5 in the Triphasil group. Subjective results were excellent for 6, good for 2 and unsatisfactory for 2 in the Diane 50 group, and excellent for 8 and good for 2 in the Triphasil group. In both groups mean free testosterone, androgen index, androstenedione and DHEAS, and an increase in SHBG were documented. 5 Triphasil and 5 Diane 50 subjects had increased cholesterol levels during the trial, the only abnormality detected. Side effects reported were recurrence of varicose veins and hemorrhoids in 1 women who withdrew, and complaints of mastalgia, nausea, dysmenorrhea, migraine, headache, backache and vaginal discharge.
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PMID:An open study of Triphasil and Diane 50 in the treatment of acne. 183 45

Results are presented of a phase 3 international multicenter trial to study the effect of a new, low-dose oral contraceptive (OC) containing 20 mcg ethinyl estradiol and 150 mcg desogestrel (Mercilon) with regard to efficacy, cycle control, blood pressure, and acceptability. In total, 1684 women from 12 European countries were included in the study. 4 pregnancies occurred, 3 of them patient failure and 1 tablet failure. The overall Pearl Index was 0.20. The frequency of irregular bleeding was comparable to that recorded with other commonly used low-dose OCs. No serious side effects occurred. The incidence of the most frequently reported subjective side effects, i.e., headache, nausea, and breast tenderness, was already low after the 1st cycle of treatment and decreased to below pretreatment levels with continued use. There was a small increase in mean body weight, which was confined essentially to young women. The preparation did not affect the mean systolic or diastolic blood pressure. This new preparation has thus far proven to be an effective, safe, and well-accepted ultra low-dose OC.
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PMID:Phase III clinical trial with a new oral contraceptive containing 150 micrograms desogestrel and 20 micrograms ethinylestradiol. 183 99

The results of evaluation of the contraceptive activity of the biphasic oral contraceptive anteovin are presented. 1 package of anteovin consists of 11 white tablets containing 0.05 mg of ethinyl estradiol and 0.05 mg of levonorgestrel and 10 pink tablets of 0.05 mg of ethinyl estradiol and 0.125 mg of levonorgestrel. Anteovin was tested according to the conventional 21-day regimen from day 5 of the cycle for 21 days, followed by 1 7-day rest period. Duration of anteovin administration ranged from 1 to 12 cycles. Anteovin was given to 160 women (aged 17 to 40 years old) who had a history of 618 pregnancies (182 ended by term delivery and 436 ended by induced abortion). During anteovin administration none of the women became pregnant. Side effects of anteovin included mild nausea during first several days in 12 women, breast tenderness in 4, and menstruation disorders in 8. The mechanism of contraceptive effect of anteovin was associated with ovulation inhibition. The changes in the basal temperature had a monophasic characteristic. Colpocytological examination showed decrease in the karyopyknotic and eosinophilic indices to 4-30%. All estrogen fractions (estrone, estradiol and estriol) in the urine showed statistically significant decrease on day 14-16 of the cycle (to 15.8 mcg/day, compared with 41.9 mcg/day in controls). The level of pregnanediol in the urine showed a decrease on day 20-23 of the cycle (0.66 mg/day, compared with 2.98 mg/day in controls). After 6 months of anteovin administration, there was a decrease in the basal and periovulation secretion of follicle-stimulating hormone, luteinizing hormone, and estradiol.
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PMID:[The clinico-pharmacological characteristics of anteovin]. 186 Apr 94

In view of the considerable debate concerning the possible failure of contraception in women taking broad spectrum antibiotics, the authors examined a group of 12 women ages 22-32 in a controlled study. Each had been on longterm therapy with oral contraceptives (OCs) containing ethinyl estradiol (EE) and levonorgestrel (Ng) for at least 6 months and all were in good general health. Blood samples were taken about 11.0 hours after dosing with OCs on days 5, 6, 7, and 8 of their contraceptive cycle, for measurement of EE2, Ng, FSH, and LH by radioimmunoassay. In addition, blood samples were taken on days 19, 20, and 21 of their contraceptive cycle for assay of progesterone concentrations in plasma. The study was repeated in the next cycle of OC use during which the patients took temafloxacin, a broad spectrum quinoline antibiotic in a dose of 600 mg twice daily for 7 days, beginning on day 1 of the cycle. All women completed the study satisfactorily as judged by diary cards, tablet counts, and plasma temafloxacin concentrations. In the early part of the study, some nausea and headaches were experienced; this was due to the taking of the drug on an empty stomach. When the antibiotic was administered with food, this problem was no longer a concern. There was no evidence of any interaction between temafloxacin and OCs. The plasma concentration of EE2 was 61.4 +or- 21.2 pg/ml in the control cycle and 68.5 +or- 26.6 pg/ml in the temafloxacin cycle. The plasma progesterone concentration was 0.53 +or- 0.1 ng/ml in the control cycle and 0.6 +or- 0.24 ng/ml in the temafloxacin cycle (p0.01). No woman demonstrated any significant rise in plasma FSH or LH concentrations during temafloxacin therapy. The authors conclude that there is no evidence for a systematic interaction between temafloxacin and OCs and that there is no need for use of alternative contraceptive methods in women taking OCs who are also being treated with temafloxacin.
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PMID:The lack of interaction between temafloxacin and combined oral contraceptive steroids. 190 91

From August 1988-June 1989, 983 physicians participated in a phase IV trial by following 7759 women using the monophasic oral contraceptive (OC), Demulen 1/35 (1 mg ethynodiol diacetate and 35 ug ethinyl estradiol) to evaluate its efficacy and safety. The total number of cycles for the study stood at 21,440. In addition, the total woman-years stood at 1787. Only 6382 patients could be evaluated for safety. 4.4% of the patients had adverse reactions to the OC, but only 1.7% of all patients stopped taking it. The leading side effects included nausea (67 cases), headache (45), amenorrhea (42), emotional changes (30), breast pain (19), dysmenorrhea (12), and 11 cases of weight gain, abdominal/pelvic pain, and bloating. Of the 280 reported adverse reactions, only 87 (31%) were considered severe. The leading serious adverse reactions were depression (10) and hypertension (6). Only 5412 patients could be used to determine efficacy. The physicians initially reported 121 (2.2%) pregnancies during the study. The researchers learned that 33 of the 84 returned 2nd questionnaires (response rate, 70%) reported that the women conceived after enrollment but before taking the OC. 36 conceived while taking it, but 8 did not take it daily. Noncompliance may have contributed to pregnancy for the remaining 28 cases. Therefore the 36 confirmed pregnancies made for a failure rate of .7%. 85.7% of the pregnancies happened in the 1st 3 months of taking the OC. Either patient noncompliance or true medication failure accounted for treatment failure. Therefore it is important for physicians to instruct patients on how to take OCs correctly.
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PMID:Efficacy and safety of ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms, with an emphasis on contraceptive efficacy. A phase IV trial. 204 81

Femovan contains 30 mcg of ethinyl estradiol and 75 mcg of gestodene. Gestodene has been used in combination oral contraceptives since 1987 in 38 countries with hardly any effect on carbohydrate and lipid metabolism or fibrinolysis. Its contraceptive reliability for menstrual cycle control and tolerance was examined. A total of 102.769 women aged 18-35 with 593.455 menstrual cycles were included in 2 phases. Most of the women were German women, but the study included women from Europe and Latin America. Although 2-8% of the women took Femovan irregularly, only 3 pregnancies occurred in 414 English women (4704 cycles), 7 in 3267 German women (36.711 cycles), and 124 in 95.906 German women (523.477) as a result of forgetfulness. The pearl index reached .16 and .22 in the 2 phases, respectively, under client failure, and .07 and .06 under method failure. Bleeding ranged from .6-2.8% of cycles, while spotting was 4.5-8.2%. The omission of menstrual bleeding occurred in less than 1% of this population. Tension in the breasts, headache, and nausea with nervousness occurred in up to 10% of the women. Nervousness, vertigo, and depression was significantly less frequent. Acne and edema occurred only in a few cases. The average increase of body weight was a maximum of .8 kg. Blood pressure was unchanged for a few cases. There were 2 and 26 cases, respectively, of thromboembolitic diseases in the 2 phases amounting to .3 and .6/1000 woman years of use which compares to .4-1.7/1000 of the Oxford-Family Planning Association cohort study results. Femovan was discontinued on medical grounds (headache, nausea, and irregular bleeding) in 10.3% of 3267 German women and in 7.5% of 95.906 German women. Femovan's acceptance rate was remarkably high, and it proved to reliable and well-tolerated.
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PMID:[Clinical experiences with femovan (Gynera)]. 209 80

The results of the clinical trial of the biphasic contraceptive agent Anteovin (G. Richter, Hungary) are reported. The package of Anteovin consists of 11 white tablets containing 0.05 mg of ethinyl estradiol and 0.05 mg of levonorgestrel, and 10 pink tablets containing 0.05 mg of ethinyl estradiol and 0.125 mg of levonorgestrel. Preliminary clinical- pharmacological studies indicated that Anteovin did not induce atrophy of the endometrium or hyperplasia of the uterine stroma; Anteovin had favorable effect on the cervix uteri and vaginal epithelium. Anteovin was tested in 42 women aged 20 to 31 years old during a total of 398 menstrual cycles. The trial was conducted from April of 1988 to September of 1989. Of 42 women, 12 used other oral contraceptive agents, 18 used intrauterine devices, and 12 practiced coitus interruptus. Anteovin was discontinued in 2 women due to dermatitis (1) and severe nausea (1). Side-effects, which did not require discontinuation of Anteovin, were recorded in 6 women (2 had hemorrhage during the first month of Anteovin administration, 3 had nausea during two cycles, and 1 had swelling of breast). Anteovin was well-tolerated by 34 women. None of the women became pregnant.
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PMID:[Practical observations of the use of the contraceptive preparation Anteovin]. 210 Sep 64

Oral contraceptives (OCs, long-acting progestins (LAPs), and IUDS are reviewed in terms of new information on safety and efficacy. OC formulations are described and their mechanism of action and efficacy indicated. Reports are provided for thromboembolism, hemorrhagic and thrombotic stroke, ischemic heart diseases, alterations in lipid and hypoprotein and carbohydrate metabolism, hypertension, coagulation changes, breast and cervical cancers, and such minor side effects as menstrual irregularities, nausea, headaches, weight gain, premenstrual syndrome effects, and mood and libido changes. Noncontraceptive health benefits and clinical considerations are discussed. Norplant, as the only long acting progestin available in the US is described in terms of its formulations, mechanism of action, sequelae and metabolic effects, menstrual irregularities, metabolic effects, nuisance side effects, candidates for insertion, method of insertion and removal, and continuation rates. 2 IUD types are identified as the only ones available in the US, Progestasert T and T-Cu-380A (Paragard). Mechanism of action, efficacy, candidates, major sequelae such as salpingitis, infertility, and uterine perforation, minor sequelae such as metrorrhagia and dysmenorrhea, and other considerations are indicated. OCs in the US contain an average of 35 mg of ethinyl estradiol and assorted progestins e.g.s, ethynodiol diacetate, norethindrone acetate, nortestosterone derivatives with a complex mechanism of action. The failure rate for use effectiveness is 6 pregnancies/100 woman years. Modern formulations have combined rates of no more than 50 to 100 adverse events/100,000 users. Some of the effects are indicated as follows: Thromboembolism accounts for 60% of adverse effects and appears to be declining along with hemorrhagic and thrombotic stroke, however, modern use studies are only partially available. Myocardial infarction related to OC use may be embolic, and has a low risk at 7/100,000 users. Low-dose contraceptives substantially reduce the associated risks. Those with risk factors need close monitoring. Norplant is useful for those not wanting to take a daily regimen and is commonly accompanied by menstrual irregularity and sometimes headaches. Continuation is 80% after the 1st year and 40% after 5 years. Candidates for IUDs are parous women in monogamous relationships, who are not at risk for salpingitis, which is related to IUD use, or sexually transmitted diseases. Continuation is 70% after 1 year compared with 50% of OC users.
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PMID:Modern trends in contraception. 212 11

The methods known to be practical for post-ovulatory contraception, defined as any substance or device used after coitus to prevent establishment of pregnancy up to 14 days after ovulation are reviewed. Most are used only in emergency for a single episode of unprotected intercourse or failed contraception, exceptions being the "visiting pill" of norethindrone used for migrant workers in China, and the IUD when inserted for this purpose as well as ongoing contraception. The physiology of ovulation, fertilization, transport of the ovum, and implantation of the blastocyst are reviewed. Estimates of the odds of becoming pregnant after an isolated unprotected intercourse range from 10-25%. High-dose estrogens, either stilbestrol (no longer used in the U.S.), ethinyl estradiol 5 mg, or conjugated estrogens 30 mg, have been used since early trials in the 1960s. Estrogen must be given for 5 days, started within 72 hours of coitus, and cause several unpleasant side effects, notably nausea, vomiting, mastalgia, and menstrual irregularity. Although no incidents have been reported, they are contraindicated for those at risk of thromboembolism. The failure rate is about 0.7%. Combined estrogen and progestagen, known as the Yuzpe method, consists of 2 dose of 100 mcg ethinyl estradiol and 1 mg norgestrel, repeated in 12 hours. The reported failure rates range from 0.2%-7.4%. Insertion of a copper IUD is effective post-coitally within 66 days, with failure rate less than 0.1%. The antiestrogen Danazol, which actually acts as an antigonadotrophin, can be used as a postcoital agent, in divided doses of 800 or 1200 mg 12 hours apart within 72 hours of exposure. Published failure rates are 2.5 and 0.9% with these doses. Progestagens alone have been studied by WHO, but failure rates were as high as 10.1% in women with frequent intercourse. Regular use was not recommended since cycles became unpredictable. Studies are being conducted on RU-486 and prostaglandins for postcoital use, in comparison with the Yuzpe regimen. A true luteolytic agent for women would seem to be the perfect postcoital agent, yet none exist.
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PMID:Post-ovulatory contraception. 222

The therapeutic efficacy of the new triphasic contraceptive agent trisistone was evaluated in 42 women (20-35 years old) with various gynecological diseases. The group included 25 with uterine hemorrhage, 4 with post-castration syndrome, 4 with endometriosis, 4 with hypogonadism, and 5 with other diseases. The drug was dispensed monthly. The patients received 1 to 14 packages of trisistone (average number 3-4). The first phase consisted of 6 violet tablets containing 0.003 mg of ethinyl estradiol and 0.05 mg of levonorgestrel; the second phase consisted 6 pink tablets containing 0.04mg of ethinyl estradiol and 0.075 mg of levonorgestrel and third phase consisted of 9 orange tablets containing 0.03 mg of ethinyl estradiol and 0.125 mg of levonorgestrel. Of 42 patients, 16 had stopped taking the drug after the first cycle, while 26 showed clinical improvement. The treatment was the most effective in patients with estrogen and gestagen insufficiency, luteal insufficiency, and primary ovarian dysgenesis. Side-effects of trisistone included hemorrhage (9.5%), headache (7.1%), sensation of pregnancy (7.1%), dizziness (2.4%), and nausea (2.4%).
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PMID:[The use of the triphasic contraceptive preparation trisiston for therapeutic purposes]. 237 4


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