Gene/Protein Disease Symptom Drug Enzyme Compound
Pivot Concepts:   Target Concepts:
Query: UMLS:C0018681 (headache)
 56,091 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

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.
 ...
PMID:The current status of oral contraceptive clinical development in Japan. 257 51

Health care practitioners are often faced with the dilemma of whether or not to provide oral contraceptives (OCs) to women who have certain chronic medical conditions. Oral contraceptive use among gestational diabetics who use OCs may be at increased risk for developing insulin- dependent diabetes. It appears that progestins are primarily responsible because they decrease the number of insulin receptors on cell membranes. Norgestrel has a more marked effect on carbohydrate metabolism than norethindrone. Estrogen may also play a role by slowing the uptake of glucose. Findings of available studies show that progestin only OCs, combined, low-dose OCs (35 mcg of ethinyl estradiol), or preparations with norethindrone are relatively safe for gestational diabetics. In mitral valve prolapse (MVP) abnormal hemodynamics at the prolapsed valve may promote formation of thrombi and lead to cerebrovascular accidents (CVAs). Oral contraceptives are also known to increase the incidence of thrombi, especially in the lower extremities. A 1986 study of 11 OC users who had had CVAS found that a specific subject of women with MVP are at risk for CVA, perhaps due to persistent clotting abnormalities, however most could safely use a combined, low-dose pill unless headaches, smoking, and MVP symptoms. Oral contraceptive use has usually been avoided in women with sickle cell disease. The major concern has been the possibility of an additive or synergistic effect of OCs on the blood-clotting mechanism. However sickle cell disease is a relative contraindication. Several studies showed that OC use, even up to 54 months, did not increase sickle cell crises, and only 5 cases of thromboses have been reported. The increase of fetal and maternal mortality, however, is a definite risk, therefore a similar low-dose pill may be safe for women with the sickle cell trait.
 ...
PMID:Oral contraceptive use in women with chronic medical conditions. 267 89

History of development, composition, effectiveness, and side effects of first and second generation steroid contraceptive agents are briefly reviewed with special emphasis on advantages of third generation contraceptives, including triphasic hormonal contraceptives. Mechanism of action of triphasic contraceptives is based on the physiological biorhythm in the formation, secretion and blood levels of estrogens and gestagens during the menstrual cycle. The first phase (5 to 7 tablets) is characterized by high levels of estrogens and relatively low levels of gestagens. The second phase (5 to 10 tablets) is characterized by relatively high levels of estrogens and gestagens. And the third phase (7 to 10 tablets) is characterized by decreased levels of estrogens and significantly increased levels of gestagens. The most commonly used gestagens are levonorgestrel, norethindrone, and norethisterone. Ethinyl estradiol is the most commonly used estrogen. During various phases of the cycle the dosage of gestagens ranges from 0.03 to 1.00 mg and dosage of estrogen ranges from 0.3 to 0.4 mg. A single package of triphasic contraceptives contains 21 tablets. Duration of a cycle is 23-25 days with 7-day interval between the cycles. Hemorrhage during the first half of the cycle can be successfully treated with additional estrogens, while hemorrhage during the second half can be treated with gestagens. Side-effects of triphasic contraceptives include headache, dizziness, and irregular menstrual cycle. Triphasic contraceptives are specifically indicated to women older than 35 years of age, to smoking women, and to women with changes in lipid metabolism.
 ...
PMID:[Triphasic hormonal contraceptives]. 267 94

Contraceptive efficacy of triphasic combined preparation trisistone (East German drug identical to triphasil) was evaluated in 80 women with the average age of 31 years. The trisistone package consisted of 6 violet tablets (0.030 mg of ethinyl estradiol and 0.050 mg of 1- norgestrel), 6 pink tablets (0.40 mg of ethinyl estradiol and 0.075 mg of 1-norgestrel), and 9 orange tablets (0.030 mg of ethinyl estradiol and 0.125 mg of 1-norgestrel). The women started to take trisistone on day 1 of the menstrual cycle and continued to take tablets in exact sequence. Indications and contraindications for trisistone were similar to those for monophasic combined contraceptives. A total of 250 cycles were followed-up. Throughout the entire trial period, no women became pregnant. Mild side-effects included subjective sensation of pregnancy (9.7%), headache (7.1%), vertigo (2.4%), and weight gain (2.4%). Almost 20% of women developed hemorrhage, usually following administration of 8-9 tablets in the middle of the 2nd phase. Repeated hemorrhage during the 2nd and 3rd cycle was an indication for discontinuation of trisistone administration.
 ...
PMID:[Our experience in using the triphasic contraceptive trisiston for contraception]. 280 85

The clinical effects of a low-dose triphasic oral contraceptive containing the new progestogen gestodene and ethinyl estradiol were investigated in phase II and III multicenter studies. The phase II study compared the clinical effects in 377 women taking this new compound during 2123 cycles with the effects of a low-dose triphasic combination of levonorgestrel and ethinyl estradiol in 362 women treated in 2088 cycles. The discontinuation rates after 6 months were similar in the two groups, and no major differences in side effects were observed. Cycle control was better during intake of the gestodene-containing preparation, since spotting occurred less frequently (P less than .05). The phase III investigation comprised 1921 women representing a total of 27,308 cycles. The Pearl index was 0.05. During the 24-month trial, 243 women (12.7%) dropped out of the study because of side effects, mainly bleeding disturbances (6.0%), headache (2.2%), and breast tension (2.0%). The results of these studies indicate that the triphasic combination of gestodene and ethinyl estradiol is well tolerated and provides high contraceptive efficacy and good cycle control.
 ...
PMID:Oral contraception with a triphasic combination of gestodene and ethinyl estradiol: results of a multicenter clinical study. 290 46

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.
 ...
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.
 ...
PMID:Multicenter trial of a monophasic oral contraceptive containing ethinyl estradiol and desogestrel. 297 60

8 women, aged 17-25, with polycystic ovary syndrome (PCO) were treated with Practil 21 (Organon) containing 30 mcg of ethinyl estradiol and 150 mcg of desogestrel, or with Planum (Menarini). Checkups were conducted 3 and 6 months later to measure hormone levels. The average level of testosterone dropped significantly from 121.5 (+ or - 50.9) ng/dl to 23.1 (+ or - 10.6) ng/dl after 3 months. The level of androstenedione also decreased significantly from 265.2 (+ or - 101.4) ng.dl to 96.7 (+ or - 22.5) ng/dl. Similarly, the level of 17-hydroxyprogesterone declined from 120.5 (+ or - 69.8) ng/dl to 24.5 (+ or - 10.7) ng/dl . On the other hand, the level of sex hormone binding globulin rose from 1.3 (+ or - .6) mcg/100 ml to 3.9 (+ or - 1.8) mcg/100 ml. Cortisone level increased significantly from 15 (+ or - 3.2) mcg/100 ml to 30.6 (+ or - 10.4) mcg/100 ml after 3 months, but the normal range (5-20 mcg/100 ml) was attained at the end. Ecographic evaluation of the size of the ovaries indicated a 18.2-66.5% reduction after 3 months. In 3 cases, the number and dimension of follicles also diminished conspicuously. Acne, hirsutism, and other symptoms of hyperandrogenism also declined. Side effects were minor and included slight weight gain, spotting and headache; treatment was suspended in only 1 case because of a grand mal seizure. The administration of this new monophasic OC proved to be a valid alternative therapy for PCO.
 ...
PMID:[Changes in plasma levels of androgens and SHBG in patients with polycystic ovary syndrome (PCOs) treated with oral contraceptives containing desogestrel]. 297 29

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.
 ...
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.
 ...
PMID:Clinical experience in Switzerland with the new monophasic oral contraceptive Minulet (75 mcg gestodene, 30 mcg ethinyl oestradiol). 307 5


<< Previous 1 2 3 4 5 6 7 8 9 10 Next >>