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Query: UMLS:C0018681 (headache)
 56,091 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Silastic implants containing the progestin, levonorgestrel, were tested as long-term contraceptives in 101 women. After three full years of exposure and 2,998 woman-months of use, no pregnancies had occurred. The continuation rates were 87% at 12 months, 79% at 24 months and 66% at 36 months. The most important side effect was excessive or irregular bleeding during the first year. No treatment was offered for this side effect other than vitamins and iron or change of method, with the exception of 3 cases where ethinyl estradiol was used one time for 2 weeks each. Bleeding disturbances led 8 patients to ask for removal of implants. Other side effects were headache, acne and lower abdominal pain. Blood and urine analysis tested 17 different parameters and all but plasma cortisol remained within normal limits throughout the study. A general tendency toward lowered cortisol values was observed and two subjects had more than one value below the normal limit for the population during the study. Glucose tolerance tests during the second year were abnormal in two women with familial diabetes but they returned to normal values spontaneously at the next test. It is concluded that levonorgestrel implants offer effective protection against pregnancy during the first three years of continuous use. Their acceptability and few side effects justify larger trials, especially if treatment of bleeding irregularities is introduced.
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PMID:A three-year clinical trial with levonorgestrel silastic implants. 38 43

Ovamin 30, a new low-dose oral contraceptive (OC) containing 30 mcg of ethinyl estradiol and 2 mg of ethynodiol diacetate, was evaluated for efficacy and acceptability in a group of women (504 patients; 3236 woman months of use) requesting OCs from their general practitioner. 39 patients withdrew from the study because of side effects which could reasonably be associated with the pill (excessive/irregular bleeding, amenorrhea, depression/headache, and breast discomfort/weight gain), and only 18 of these were menstrual disorders. 12 patients withdrew from the trial to conceive. 1 involuntary pregnancy occurred, and 58 patients were lost to follow-up. An early establishment of acceptable bleeding cycles was maintained in later cycles. The pregnancy rate for this preparation by the Pearl Index was .4/100 woman years with 95% confidence limits of .01-2.24. Ovamin 30 appeared to be an effective and well tolerated low-estrogen OC, and further studies may determine whether side effects are reduced with 30-mcg products as opposed to those containing 50 mcg of estrogen.
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PMID:An open assessment of a new low dose oestrogen combined oral contraceptive. 62 4

Multicenter clinical trial of Ovoresta M, a low-dose combined oral contraceptive containing 0.75 mg lynestrenol and 0,0375 mg ethinyl estradiol, is reported. The trial included 150 women (2,541 treatment cycles). No pregnancies were observed in the group. Bleeding was seen in 95.1% of all treatment cycles between 2-6 days after the last pill was taken, and was not materially different from normal menstruation in 89.3% of cases. Irregular bleeding occurred in 8.1% of cycles. Other side effects included nausea and vomiting, headache, breast fullness, leg circulatory complaints, infections, nervousness, and depression; 140 patients had no previous treatment with oral contraceptives. 2 patients Dropouts included 3 patients who desired to become pregnant, 2 because of irregular bleeding, and 3 others for other reasons. Because of the low dosage of active ingredients the authors consider Ovoresta M a welcome supplement to existing oral contraceptives.
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PMID:[Clinical aspects of a new, very low dose combination contraceptive]. 63 15

The side-effects encountered by 1,090 patients taking the oral contraceptive pill were reviewed. The main side-effects were migraine, headaches, weight gain, depression, and irregular bleeding. Reasons for changing the Pill are discussed, and recommendations are suggested for a way of monitoring patients taking the Pill. Analysis of the results show that 50 per cent of patients are happy with their first Pill, and that the 30 microgram pill produces fewer side-effects.
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PMID:A retrospective survey of over 1,000 patients on oral contraceptives in a group practice. 95 17

The US Food and Drug Administration (FDA) has not approved any injectable contraceptives, but, in December 1990, it approved Norplant, an implantable contraceptive. Family planning providers insert 6 capsules, each with 36 mg levonorgestrel, in a fan shape under the dermis of the upper arm. Norplant protects against pregnancy for at least 5 years . Fecundity returns within 2 weeks after capsules' removal. The steady low levels of levonorgestrel keep down both luteinizing hormone and follicle stimulating hormone levels. It suppresses ovulation and thickens the cervical mucus. Contraindications of Norplant are active thromboembolism, undiagnosed genital bleeding, acute liver disease, liver tumors, and breast cancer. Phenytoin and other drugs which speed up liver metabolism reduce Norplant's efficacy. The leading side effect of Norplant is irregular bleeding patterns. Some less common side effects include headaches, nervousness, dizziness, and acne. First year continuation rates range from 76 to 99% and 25 to 78% for 5 years of use. More than 85% of Norplant users are satisfied. Both continuation and satisfaction are associated with patient counseling. Research and development of biodegradable and other nonbiodegradable implants is ongoing. The most common injectable contraceptive in the world is Depo-Provera. 150 mg of Depo-Provera every 3 months suppresses ovulation, deteriorates the endometrium, thickens cervical mucus, and reduces motility of the tubes, thereby providing adequate protection against pregnancy. Some research shows Depo-Provera use significantly increases the low-density lipoprotein to high-density lipoprotein ratio, thereby increasing the risk for atherogenesis. Effectiveness rates match those of Norplant. Norethindrone enanthate was the first injectable contraceptive. Even though 40 countries approve it, the US does not. Animal studies of injectable microspheres or microcapsules with either progestogen or progestogen and estrogen are in progress.
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PMID:Injectable and implantable contraceptives. 138 11

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

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

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

Medroxyprogesterone acetate injections (Depo-Provera) were given to 625 women at 3 monthly intervals involving 693 episodes. Ages at entry to the study ranged from 15-51 years with the majority in their 20s and a mean age of 30. Length of exposure ranged from 3-168 cycles. 4 women have received more than 160 continuous cycles of DMPA. Of the medication-induced reasons for discontinuing DMPA, bleeding was the most common with an incidence of 10.5% followed by depression (1.4%), weight gain (1.4%), and loss of libido (1.6%). No patient ceased treatment because of headaches, recurrent vaginal infections, mastalgia, nausea, chloasma, hypertension, or other vascular illnesses. The 59 women who move away or were lost to follow-up accounted for 405 cycles of treatment. The solitary unplanned pregnancy occurred in a 28-year-old obese woman who had previously had other method failures, once with an IUD and once with oral contraceptives (OCs). No association was found with carcinoma of the cervix. Of 80 women ceasing treatment to become pregnant, only 1 women has required the assistance of chlomiphene and conceived 2 years after ceasing DMPA. Amenorrhea was the side effect most appreciated by the women using DMPA. Due to the problem of irregular bleeding, it is wise to warn prospective patients about the lack of bleeding control that they have 1 chance in 10 of having relative menorrhagia. Women using OC subject to frequent vaginal moniliasis had a marked reduction in episodes after switching to DMPA. Chloasma, 1 of the minor stigmas of OC, was not induced in any of the patients. DMPA is a safe and efficient reversible method of contraception for women who have various gynecological conditions or problems associated with using OCs.
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PMID:Medroxyprogesterone acetate as an injectable contraceptive. 296 70

Contraceptive implants containing progestin have been marketed in Finland since 1984. The method utilizes 6 silicon capsules of 36 mg levonorgestrel that are implanted inside the upper arm under local anesthesia. Each capsule is 34 mm long and 2.5 mm wide. The capsules release 100 mcg levonorgestrel a day during the 1st 3 months, after which dosage decreases to a level of 30-35 mcg a day within 15 months. The rate of release remains the same for a period of up to 6.5 years. Some users experience no ovulation or an incomplete luteal phase. The level of estradiol varies, although FSH, LH and androgen levels do no essentially change. Cholesterol ratios remain unchanged, but the levels decrease somewhat. Blood coagulation problems due to menstrual problems, primarily frequent, irregular bleeding and spotting. Side effects such as headaches, weight gain, mood changes can be caused by the capsule, as well as the contraceptive pill. During implantation and removal there is a small (0.3) risk of infection. Teratogenic and mutagenic effects are unlikely. Studies have shown no pregnancies occurring in the 1st 2 years of use. The 3rd year, the cumulative rate has been shown to be 0.3, and for the 4th year 0.7. To a great extent, contraceptive implants are utilized by women who have had bad experiences with other methods, and who already have the desired number of children. This method offers much promise to those women in developing countries, and has been proven to be well tolerated there.
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PMID:[Subcutaneous hormone capsules]. 333 Nov 42


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