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56,091 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Effects of a new low-dosage combination oral contraceptive containing .5 mg WY3707 (a progestational substance) plus .05 mg ethinyl estradiol were studied on 30 normal women. Findings based on 25 patients remaining in the study for 5 months indicate a weight gain (64%), a tendency to hypo- and oligomenorrhea (58.3%), headache (52%), dizziness (44%) and nausea (20%) as common side-effects. Blood pressure recordings were below 140/90 and had no major variations. Blood sodium and potassium levels, measured before therapy initiation and 2 and 5 months after use, showed no significant changes. Discussion centers on 20 previous studies relating oral contraceptives to blood electrolytes and pressure and weight and menstrual changes.
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PMID:Effect of a new low-dosage oral contraceptive pill on blood electrolytes. A combined clinical and laboratory evaluation. 576 88

A total of 835 women in a Swedish multicenter study completed a total of 6472 oral contraceptive (OC) treatment cycles; half of the women were allotted at random to use the monophasic OC Neovletta, also known as Microgynon 30 (30 mcg ethinyl estradiol + 150 mcg levonorgestrel in each tablet) and the 2nd half was allotted to Trionetta, also known as Triquilar, Trigynon, and Logynon (6 tablets with 30 mcg ethinyl estradiol + 50 mcg levonorgestrel, 5 tablets with 40 mcg ethinyl estradiol + 75 mcg levonorgestrel and 10 tablets with 30 mcg ethinyl estradiol + 125 mcg levonorgestrel). The latter version was also present in a 28-day version containing in addition 7 placebo tablets to be used in the otherwise tablet-free interval. There was a comparatively high number of missed tablets. Tablets were omitted in 8.1% of the total number of cycles in the triphasic group and the corresponding figure for the monophasic group was 9.4%. Despite this fact, only 1 pregnancy occurred during the observation period and during treatment with Trionetta 21. This pregnancy was classified by the attending physician as clearly due to patient failure (3 consecutively missed tablets). Both formulations exerted a normalizing effect on cycle length, being more pronounced with the triphasic formulation. The 2 combinations reduced to the same extent previously prolonged bleeding periods, i.e., greater than 7 days. The percentage of women with bleeding periods longer than 7 days in the 6th and 12th treatment cycle was 1.4% and 0.6%, respectively, for Neovletta and 0.9% and 0.6%, respectively for Trionetta. The 2 combinations reduced to the same extent previously profuse bleedings. In the last untreated cycle, the percentage of women with profuse bleeding was 6.7% in the Neovletta group and 9.1% in the Trionetta group. Failure of getting withdrawal bleeding was rare in both treatment groups, but the triphasic formulation was found to be superior to the fixed dose combination. In the Neovletta group 85.9% completed the 1st trial period of 6 cycles. The corresponding figure for Trionetta was 83.9%. Acne and headache were, for both formulations, reported less frequently during treatment than in the last untreated cycle. 1 case of thrombophlebitis was reported during treatment with Neovletta. There was no statistically significant increase of the mean blood pressure or the mean body weight during treatment.
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PMID:Comparison of contraceptive acceptability of levonorgestrel and ethinyl oestradiol administered in one three-phasic (Trionetta) and one monophasic (Neovletta) version. 634 25

Oral contraceptive agents (OCs) containing levonorgestrel, 150 micrograms, and ethinyl estradiol, 30 micrograms, account for almost half the sales of such agents in the United Kingdom. The remarkable success of this formulation has occurred primarily because it provides extremely low doses of both hormonal constituents yet still gives most users a very acceptable bleeding pattern: the incidence of breakthrough bleeding is about 6% and of amenorrhea, less than 3%. Approximately 90% of users have cycle lengths of 28 +/- 3 days. The risk of serious side effects is significantly lower than with formulas containing higher doses of progestogen and/or estrogen. Minor side effects occur in only a small percentage of cycles. Headache is reported in approximately 10% of all cycles and should be regarded as a potential indicator of increased risk. If it presents as focal migraine, use of the combined OC should be discontinued. The contraceptive effectiveness of the 150/30 formulation is similar to that of the 50 micrograms formulations among compliant women; in less compliant women the margin of error is reduced, and the possibility of an increased risk of accidental pregnancy must be considered.
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PMID:The 150/30 formulation. Experience in the United Kingdom. 640 2

Compilation of recent data on 1130 female volunteers from 17 US sites enrolled in a study of a new low dose combination oral contraceptive (OC) containing .15 mg levonorgestrel and .03 mg ethinyl estradiol are reported. All clients had complete histories and physical examinations at entrance and at 6 month intervals during treatment, and about 20% also had blood sugar, blood urea nitrogen, and liver profile determinations. Follow-up evaluation was performed after the 1st and 3rd cycles and every 3 cycles thereafter to determine patterns of pill taking, bleeding episodes, untoward effects, and concomitant medication. Clients ranged in age from 15-40 with mean age of 23.6; 76.1% were white, 11.9% black, 7.5% Hispanic, and 4.4% Oriental. 61.9% were of proven fertility and 92% had regular cycles. 48.1% of the study population had not used female hormones or been pregnant within 60 days of enrollment. A total of 11,064 cycles over a maximum 31 cycles of treatment are reported. Despite 1-6 or more missed pills in 1623, or 14.7% of the cycles, only 3 pregnancies were reported, only 1 presumed to be a method failure, for a use-effectiveness Pearl index of .35/100 women years of usage. Use of the formulation resulted in a mean cycle length of 28.5 days. 92.7% of cycles ranged from 26-30 days, almost equal to pretreatment values. The frequency of light menstrual flows increased. Breakthrough bleeding was reported in 669 cycles, or 6.0%, while spotting occurred in 852 cycles, or 7.7%. Amenorrhea was reported after 194 cycles (1.8%). No reports of post-pill amenorrhea were made. Incidence of side effects was very low. Only acne, breast discomfort, dysmenorrhea, gastrointestinal symptoms, headache, nausea, and vaginal discharge were reported in more than 1.0% of cycles. The pill had essentially no effect on weight or blood pressure, and produced no clinically significant laboratory abnormalities in hematology, urine, blood sugar, blood urea nitrogen, or liver profile determination. A total of 515 subjects (45.6%) discontinued use of the drug for various nonmedical reasons. Another 146 women (12.9%) discontinued use and gave medical reasons; 132, or 11.7%, were commonly reported side effects of OCs such as breakthrough bleeding, headache, and nausea. Clinical trials with the formulation have shown it to be a safe and effective ultra-low dose combined OC agent whose mode of action is primarily gonadotropin suppression and subsequent anovulation.
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PMID:A new ultra-low-dose combination oral contraceptive. 640 5

102 patients using Trinordiol, a triphasic oral contraceptive (OC) containing ethinyl estradiol and d-norgestrel, were followed for 932 cycles in a study of secondary effects. Follow-up visits were scheduled after 1,3, and 6 months and every 6 months thereafter. 26 patients discontinued use of the pills during the study after using them for a total of 159 cycles. 5 discontinued because of abdominal pain, 1 for breast tenderness, and 1 because of headaches or migraines. 7 discontinued because of metrorrhagia, 4 for weight gain, 3 for amenorrhea, 2 for nausea and vomiting, and 1 each for nervousness, water retention, acne, desire for pregnancy, leaving the country, hypertension, and unknown motivation. the average age of patients was 23.6 years, with a range from 14-48. 76% were aged 15-29 years. 52.9% were nulliparas. 58.8% were Belgian, 21.6% were from Mediterranean Europe, 10.8% were Moroccan, and 7.9% were from black Africa. Only 1 patient, a 37 year old, developed hypertension. 15 patients gained more than 2 kg and 17 lost more than 2 kg. 15.8% complained of spotting during the 1st cycle compared to 3.1% during the 6th cycle, 5.2% during cycle 7-12, and 9.1% during cycle 13-30. Among 35 patients who did not discontinue treatment, 7 complained of amenorrhea and 1 of scanty menstrual bleeding, 14 of pain including 7 cases of pelvic pain, 2 of dysmenorrhea, 3 of breast tenderness, and 2 of headaches, 15 of leukorrhea, 3 of nausea, 2 of dizziness, and 1 each of fatigue, acne, galactorrhea, and cutaneous pruritus. 1 case of myoma at the level of the uterine cornu was identified after 24 cycles of treatment. In all, 61 patients had some complaint, while 41 were totally satisfied. No patient became pregnant during the study.
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PMID:[Clinical study of the secondary effects associated with taking a triphasic anti-ovulatory contraceptive]. 670 4

A randomized double-blind study of two combined oral contraceptives and two progestogen-only oral contraceptives was conducted using the same protocol at WHO Collaborating Centres for Clinical Research in Human Reproduction in Bombay and Ljubljana of the 518 women admitted to the trial, 123 received mestranol 50 micrograms + norethisterone 1mg (MES 50 + NET 1); 137 received ethinyl estradiol 30 micrograms + levonorgestrel 150 micrograms (EE 30 + LNG 150); 130 received norethisterone 350 micrograms/NET 350); and 128 received levonorgestrel 30 micrograms (LNG 30). At one year, between 52.6 and 61.0 percent of those recruited had discontinued oral contraceptive use for all reasons, and by two years, between 70.5 and 76.5 percent had discontinued the treatment. These rates did not differ between the four treatment groups. However, discontinuation rates for all medical reasons at one and two years, and at two years pregnancy rates and discontinuation rates for bleeding disturbances, were significantly lower in the EE/LNG preparation. The groups receiving the MES/NET, LNG and NET had similar pregnancy rates, discontinuation rates for all medical reasons and all bleeding disturbances. There were two ectopic pregnancies among the 22 pregnancies in the progestogen-only groups. Discontinuation because of headache, dizziness and other central nervous system symptoms were significantly more common in those receiving MES/NET compared to EE/LNG. In contrast, discontinuation for gastro-intestinal disturbances were significantly higher in the EE/LNG combined preparation. Bleeding disturbances in the first few cycles tended to be higher in NET than in the LNG group. The data suggest that greater consideration be given to the benefits and risks of including progestogen-only oral contraceptives in the family planning programmes of some countries.
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PMID:A randomized, double-blind study of two combined and two progestogen-only oral contraceptives. 680 62

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 advantages of the microdose progestogen-only approach to contraception include: low hormonal intake, non-inhibition of ovulation, and nonadministration of exogenous estrogen. Results of pilot trials with 2 regimens are reported. Medication A was given to 80 women and consisted of 30 mcg levonorgestrel taken daily on days 5-14 of the menstrual cycle, followed by a combination of 500 mcg norgestrel with 50 mcg ethinyl estradiol taken daily on days 15-24. The Medication B group (101 women) took 30 mcg levonorgestrel on days 5-14 and 150 mcg levonorgestrel with 30 mcg ethinyl estradiol daily on days 15-24. Detailed medical histories and physical and laboratory examinations were used to screen patients with contraindications to hormonal contraceptives. The patients in both groups were young healthy married women, all had previous pregnancies, and the majority were white. The women kept diaries of pill intake, sexual intercourse, bleeding, and symptoms and returned for follow-up monthly for 6 months. 493 cycles were studied for Medication A and 792 with Medication B. In 36 patients in the Medication B group, measurements of high density lipoproteins and cholesterol were taken on admission and on the 21st day of the 3rd and 6th cycles. For Medication A, a total of 179 days (1.8%) of intermenstrual bleeding was reported. Breakthrough bleeding was reported by 27.5% of the patients, occurring in 6.5% of the cycles. Spotting for this group was reported by 26.3% in 6.1% of the cycles. For Medication B, 210 days (1.4%) of intermenstrual bleeding was reported. Breakthrough bleeding was reported by 25.7% of the group in 4.4% of the cycles; 13.9% reported spotting in 4.0% of the cycles. 3 patients in each group discontinued for medical reasons including headache and nervousness in the Medication A group, and breakthrough bleeding in the Medication B group. 2 pregnancies occurred in the Medication B group, each patient had missed the 10th microdose tablet and 1 also missed the 9th tablet. For all symptoms (e.g., headache, nervousness, dysmenorrhea) more women reported the occurrence of the symptom before treatment than during treatment. The mean values for cholesterol and high density lipoproteins in the 36 sampled patients remained within normal range but small decreases were noted. Better cycle control was suggested with Medication B but the results were not submitted to statistical analysis because the groups were small and not random. The data also suggest that the incidence of intermenstrual bleeding might be reduced by the administration of 1 additional combination tablet in each cycle. Further investigation is needed for clarification.
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PMID:Progestogen-only microdose followed by estrogen-progestogen combination, a new approach to oral contraception. 712 33

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


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