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Query: UMLS:C0027497 (nausea)
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The efficacy and tolerability of a new oral contraceptive, norgestimate/ethinyl estradiol (250 micrograms of norgestimate/35 micrograms of ethinyl estradiol; Cilag GmbH Research, Sulzbach, Germany) were examined in an open-label study of 59,701 women who were evaluated during 342,348 menstrual cycles; 42,022 women completed the planned treatment regimen of six cycles. A use-efficacy (overall) Pearl index of 0.25 pregnancies per 100 woman-years was calculated based on 342,348 cycles. Tolerability was assessed for all women who completed six treatment cycles. Reductions in mean cycle length and duration of bleeding were noted; 32% of the women experienced reductions in the intensity of bleeding by the end of cycle 6. After six cycles of use, amenorrhea occurred in 1%, spotting in 4%, and breakthrough bleeding in 3% of the participating women. Treatment with norgestimate/ethinyl estradiol had minimal effects on weight, blood pressure, pulse, lipid metabolism, and blood glucose. Adverse effects (acne, nausea, or headaches) occurred at low frequencies and in many cases, were reduced compared with pretreatment levels. The results of this large-scale open trial were comparable with results from two other multicenter trials of the same formulation.
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PMID:The efficacy and tolerability of norgestimate/ethinyl estradiol (250 micrograms of norgestimate/35 micrograms of ethinyl estradiol): results of an open, multicenter study of 59,701 women. 160 86

The Norplant System consists of 6 capsules each containing 36 mg of crystal line levonorgestrel (LNG), for a total dose of 216 mg LNG. The capsules are inserted subdermally in the mid-upper arm, and LNG diffuses continuously through the capsule walls for 5 years. In the United States the Norplant System was approved in December 1990. The initial rate of hormone delivery is about 85 mcg/day, then decreases over the next 9 months to 5 mcg/day, and over the ensuing 9 months to 35 mcg/day. Thereafter, the diffusion rate levels off for the next 3.5 years, averaging around 30-35 mcg/day. Removal results in a drop in the plasma concentration of levonorgestrel to below contraceptive levels within 24 hours and below the detectable limit of .1 pg/ml at 96 hours. Preliminarily data from 402 users over 5 years show improvements of Norplant produced better efficacy in all weight classes and a lowered cumulative rate of 1.1 pregnancies of 100 users. The pregnancy rate for the first year of use is 02., better than for oral contraceptives. Side effects include headache, nervousness, nausea, dizziness, dermatitis, acne, change of appetite, breast tenderness, minimal weight gain, some change in hair distribution, and adnexal enlargement. Adverse reactions include breast discharge, possible cervicitis, musculoskeletal pain, abdominal discomfort, leukorrhea, and vaginitis. More than the usual number of bleeding days occurred in slightly more than one fourth of the patients, prolonged bleeding in 27.6% spotting in 17.1% and amenorrhea in 9.4% of patients. Hyperlipidemic users should be observed for possible low-density lipoprotein elevations. The cumulative discontinuation rate for pregnancy was 3.9 per 100 users; for bleeding irregularities the rate was 25.1 per 100 users, and for other medical results it was about 22.4 per 100 users. Personal reasons for discontinuation accounted for 38.7 per 100 users, equivalent to a cumulative continuation rate of about 30 per 100 users over the 5-year duration.
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PMID:The NORPLANT system of contraception. 168 4

This literature review compares the merits and disadvantages of the levonorgestrel-releasing IUD made by Leiras Pharmaceuticals, Turkey, Finland (LNG-IUD-20), with the Nova-T, Copper-T (TCu) and 220C, and Copper-T-38-Ag (TCu-380Ag). This IUD releases 20 mcg levonorgestrel daily from a Silastic sleeve on the vertical shaft containing 52 mg. The plasma level stabilized after a month at about 0.2 ng/ml, about half as high as that seen with Norplant implants. It is identical in size to the Nova-T. The Cu-T IUDs differ with respect to copper wire or sleeves, or silver-cored wire. The chief studies reviewed here were 2 multi-center trails primarily in European countries, and a 2 large multi-center trials in India. Cumulative pregnancy rates were 0.0 to 0.6 per 100 users for the LNG IUD, compared to slightly higher failures for inert or copper IUDs. While removal rates for bleeding, pain and pelvic inflammatory disease were lower for the LNG-IUD-20, removals for oligomenorrhea, amenorrhea and hormonal side effects were higher than for the other IUDS. In the Indian trials, removals for amenorrhea and irregular bleeding were much higher than rates reported in the European studies, resulting in significantly lower continuation rates overall. The results pointed to district benefits for the LNG-IUD-20, such as lower blood loss and anemia, relief of dysmenorrhea and menorrhagia, as well as possible lower risks of ectopic pregnancy in case of failure, less PID (pelvic inflammatory disease), and the claim by the maker that strictly correct placement is not necessary. Disadvantages of the LNG-IUD-20 are more difficult insertion due to the wider diameter; oligomenorrhea, amenorrhea and irregular bleeding; hormonal side effects such as acne, weight gain, nausea, headache and breast tension; and potential risk of functional ovarian cysts. The LNG-IUD-20 is considered comparable to copper IUDs in effectiveness, safety, longevity, and return to fertility after removal. Users should be counseled that the oligomenorrhea or amenorrhea is neither a medical problem or indicative of infertility, is common for the 1st 2 months, is reversible on removal, may signal an improved hemoglobin profile, relief of dysmenorrhea, and may be preferred to heavy bleeding from other IUDS. The program implications of this IUD are potential lower incidence of ectopic pregnancy and PID. The effect of its use on breast feeding, cost-effectiveness compared to Norplant, in-country manufacture, and cultural acceptance need to be determined in specific locales.
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PMID:An evaluation of the levonorgestrel-releasing IUD: its advantages and disadvantages when compared to the copper-releasing IUDs. 177 15

The International Planned Parenthood Federation (IPPF) new statement on the diagnosis of pregnancy was drawn up in April 1990. A pregnancy diagnosis includes clinical evaluation of the woman's history, symptoms, physical examination, and pregnancy tests. Pregnancy symptoms may include amenorrhea, nausea, vomiting, enlargement and tenderness of the breasts, frequent urination, and changes in appetite and food and drink habits. If biochemical testing is not possible, a reliable clinical diagnosis of pregnancy cannot take place before 6-8 weeks. At this time, the clinician can observe cervical softening and uterine softening and enlargement if a woman is pregnant. If the uterine size does not match the length of amenorrhea, clinicians should suspect the following: earlier or later conception than indicated, ectopic pregnancy, incomplete or missed spontaneous abortion, twin gestation, hydatidiform mole, or other uterine anomaly. They should suspect ectopic pregnancy in women with smaller than expected uterine size when they have been sterilized or are using an IUD or are using low-dose progestogen-only pills or Norplant. They should refer women with smaller than expected uterine size who are experiencing bleeding and/or pain to a more sophisticated clinical facility, where an accurate diagnosis of and adequate treatment for ectopic pregnancy can be done. Biochemical pregnancy tests consist of antibodies that mark human chorionic gonadotropin (hCG) from a urine or serum sample. hCG levels increase beginning about 10 days after fertilization. The most convenient and inexpensive pregnancy test for clinics is the immunoassay test (slide test), which requires a urine or serum sample. It can provide reliable results a few days after the missed menstrual period. Clinicians should provide appropriate counseling regardless of whether the client wishes to continue or terminate the pregnancy.
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PMID:New IPPF statement on the diagnosis of pregnancy. 192 37

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

Risk factors for ectopic pregnancy include previous ectopic pregnancy, current intrauterine device use, prior fallopian tube surgery, previous pelvic inflammatory disease and a prior history of infertility. Abdominal pain is the most common symptom, followed by amenorrhea or vaginal bleeding, nausea, vomiting, syncope and dizziness. Referred shoulder pain following the onset of abdominal pain is characteristic of intraperitoneal bleeding and, in the appropriate clinical setting, strongly suggests a ruptured ectopic pregnancy. A coordinated evaluation includes measurement of serum human chorionic gonadotropin concentration and transabdominal or, preferably, transvaginal ultrasonography. Treatment is primarily by one of a variety of surgical techniques. Medical therapy with methotrexate or other drugs is currently under investigation.
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PMID:Management of ectopic pregnancy. 218 38

Clinical trials in Europe have found that a single oral dose of RU-486, followed by prostaglandin administration, effectively and safely terminates early pregnancy in about 95% of women. In a multicenter study carried out in France, 1 600-mg dose of RU-486, followed 36-48 hours later by intramuscular sulprostone or intravaginal gemeprost, induced complete abortion in 96% of 2000 women with up to 49 days of amenorrhea. In a British multicenter study, the combination of RU-486 and intravaginal gemeprost induced abortion in 95% of 600 women with up to 63 days of amenorrhea. RU-486 is not effective in aborting ectopic pregnancies. Bleeding usually starts 1-2 days after treatment and lasts for 1-2 weeks. About 1% of patients have required curettage since the amount of blood loss exceeds that in a normal menstrual period. The other side effects recorded with any frequency--abdominal cramping, nausea, vomiting, diarrhea, and headache--are all transitory and mild. Only 1 case of myocardial infarction has been reported in the more than 20,000 RU-486 acceptors studied. Endometritis and salpingitis are extremely rare complications. There have been no maternal deaths, and no fetal abnormalities have been observed in women who took RU-486 alone early in pregnancy and failed to abort.
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PMID:Mifepristone (RU 486). 224 20

The authors report a case of toxic hepatitis in a woman of 22 years of age in the third trimester of her first pregnancy treated by methyldopa for hypertension of pregnancy which was diagnosed at 33 weeks of amenorrhoea. The prodromal symptoms were mild and consisted of nausea, vomiting and rise in temperature and this phase was associated with febrile jaundice without pruritus and it was only associated with coagulation disorders in the third stage of labour. This was a case of mixed cytolytic hepatitis (ASAT x 3N) and cholestasis (x 1.5N). The outcome was fatal. The patient died three days after delivery following haematemesis and renal failure as well as hepatic encephalopathy. The main diagnostic feature was acute hepatic stasis in spite of the absence of pruritus and the presence of a raised temperature after hematolytic, viral and obstructive causes had been eliminated. Histology confirmed that there was toxic hepatitis. This aetiology was suggested by the timing of the symptoms after MD (methyldopa) had been taken. Elkington described methyldopa hepato-toxicity in 1969. Fatal cases in the literature were in patients who were over 40 years of age. Methyldopa is used in pregnant women because of its safety as far as the fetus is concerned. Mechanism by which it causes toxic hepatitis is a combination of abnormal metabolism (the cytochrome P450 chain produces an antigen) and an immune reaction in response to this antigen and these explain why such severe and potentially fatal forms of the condition exist.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:[Fatal toxic hepatitis in pregnancy. A discussion of the role of methyldopa]. 232 42

Thirteen women with hyperprolactinemic amenorrhea were treated with lisuride (Dopergin, Schering AG, Germany). The dosage of lisuride was started with 0.1 mg per day and increased to 0.2 mg per day after one week of treatment. Further increment of the drug depended on clinical and laboratory responses of the patients. One patient dropped out from the study due to marked nausea and dizziness. In ten out of twelve patients serum prolactin decreased to normal. Most patients received lisuride 0.2-0.4 mg per day. Only one got more than 0.4 mg per day. Two patients whose serum prolactin levels did not decrease to normal range had uterine bleeding, quite regularly. Menstrual cycle resumed within 23 to 141 days. All galactorrhea disappeared during treatment. Two of five patients who desired pregnancy became pregnant during the treatment. The course and outcome of pregnancies were normal. Common side effects of lisuride treatment were nausea and dizziness. In conclusion, this study demonstrated that lisuride is another effective prolactin inhibiting agent even at low dose. This drug provides an alternative treatment to bromocriptine.
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PMID:The efficacy of lisuride in the treatment of hyperprolactinemic amenorrhea. 235 12

CV 205-502 is a nonergot oral dopamine agonist with specific D2 activity, which has a prolonged suppressive effect on serum PRL and may have fewer side-effects than other dopamine agonists. We treated 26 hyperprolactinemic women with this compound given as a single bedtime (hs) dose for up to 12 weeks. All had gonadal dysfunction, either amenorrhea or oligomenorrhea, and 15 had galactorrhea. The initial and subsequent doses were administered in a randomized fashion; the initial dose ranged from 0.01-0.05 mg, and the dose at 12 weeks ranged from 0.03-0.09 mg. The women were evaluated every 2 weeks, and the dose was increased by 0.02 mg every 4 weeks if the serum PRL level was greater than 20 micrograms/L. Of the 26 women initially enrolled, 24 completed 12 weeks of therapy, and 2 discontinued therapy because of side-effects. Thirteen women (54%) had return of menses, and 12 (80%) had either a decrease in or disappearance of galactorrhea. Serum PRL concentrations decreased to a variable degree in all patients; 13 (54%) achieved a normal serum PRL level (less than or equal to 20 micrograms/L). The mean (+/- SE) pretreatment serum PRL concentration was 129 +/- 34, and it was 29.9 +/- 5.9 micrograms/L after 12 weeks of treatment (P = 0.005). The mean (+/- SE) percent reduction in serum PRL was 66.5 +/- 5.0% (median, 78.0%). A dose response was not demonstrated (r = -0.08; P = 0.70) among the 6 dose groups during the last 4 weeks of therapy. In 5 women, serum PRL levels, measured frequently for 24 h after treatment remained low. Side-effects after the initiation of therapy included nausea, headache, and morning fatigue in 10 women. These symptoms caused 2 women to discontinue therapy; they subsided in the other women. An optimal dose was not determined and will probably need to be determined by titration in each patient. CV 205-502, given once daily, appears to be a safe and effective alternative to other dopamine agonists in the treatment of hyperprolactinemia.
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PMID:CV 205-502 treatment of hyperprolactinemia. 252 63


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