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 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Research in the area of oral contraception currently focuses on the development of selective progestogens that combine targeted progestational and antiovulatory activity with a minimal potential for androgenicity. The present dual-center study was conducted to investigate the efficacy, tolerability, and safety of a new monophasic oral contraceptive (OC) containing 250 micrograms norgestimate in combination with 35 micrograms ethinyl estradiol (Ortho-Cyclen or Cilest). Ninety-seven healthy women of childbearing age participated in the study: 37 received the new norgestimate/ethinyl estradiol combination OC as primary therapy and 31 were switched over from other OCs. The norgestimate/ethinyl estradiol formulation was well tolerated and was associated with excellent cycle control. After six cycles of use, there were no statistically significant differences in the incidence of spotting or breakthrough bleeding compared with baseline, nor were there any significant changes in the incidence of headache, nausea, or mastalgia. Body weights remained constant for the duration of the study, as did systolic and diastolic blood pressures. Of particular note was the absence of any statistically significant alterations in metabolic parameters, including blood glucose or lipoprotein levels. These findings are consistent with the results of several other European studies and indicate that the norgestimate/ethinyl estradiol combination OC combines superior cycle control with minimal risk of androgenic side effects.
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PMID:Clinical experience with a new norgestimate-containing oral contraceptive. 134 20

Research in the area of oral contraception currently focuses on the development of selective progestogens that combine targeted progestational and antiovulatory activity with a minimal potential for androgenicity. The present dual-center study was conducted to investigate the efficacy, tolerability, and safety of a new monophasic oral contraceptive (OC) which contains 250 mcg norgestimate in combination with 35 mcg ethinyl estradiol (EE; Ortho-Cyclen or Cilest). 97 healthy women of childbearing age were part of this study; 37 received the new norgestimate/EE combination OC as primary therapy and 31 were switched over from the other OCs. The formulation was well-tolerated and was associated with excellent cycle control. After 6 cycles of use, there was no statistically significant difference in the incidence of spotting or breakthrough bleeding as compared with the baseline. Nor were there any significant changes in the incidence of headache, nausea, or mastalgia. Body weights remained constant for the duration of the study as did systolic and diastolic blood pressures. Of particular interest was the absence of any statistically significant alterations in metabolic parameters, including blood glucose or lipoprotein levels. These findings are consistent with the results of several other European studies and indicate that the norgestimate/EE combination OC combines superior cycle with minimal risk of androgenic side effects.
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PMID:Clinical experience with a new norgestimate-containing oral contraceptive. 167 78

A study using data from the United Kingdom (UK), Denmark, and Sweden and an ongoing study in the UK found a significant association between estrogen content of high dose combined oral contraceptives (OCs) and all thromboses except venous thrombosis of lower limb. In fact, the ongoing study and another study both found a distinct association between progestogen dose and arterial disease. These association prompted formulators to decrease OC estrogen and progestogen (norethindrone and levonorgestrel) content. These new formulations entered the market after 1975. The early 1980s witnessed the introduction of yet another generation of genane progestogens which were developed in hoped of reducing the incidence of thrombosis. Clinical trials found their contraceptive effectiveness to be comparable to those of the older demonstrated that their effect on associated incidence of bleeding is similar to the older OCs and falls over time. Moreover, even though the 3rd generation OCs have brought on the same side effects (weight gain, mastalgia, and nausea) as the others, the frequency has been at least, and often less, than the others. So far data have not implicated the 3rd generation OCs in impairing glucose tolerance. In addition, research has demonstrated that 3rd generation formulations cause a small increase in high density lipoprotein and either did not change or reduced low density lipoprotein and total cholesterol levels. Thus the new combined OCs do not promote atherosclerotic changes in lipid metabolism. Even though more research is needed, the data have indicated that physicians should continue to prescribe the 3rd generation OCs.
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PMID:Clinical experience with the recently developed progestogens. 167 79

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

In a randomised parallel-block trial in thirteen European centres bromocriptine 2.5 mg twice a day was compared with placebo therapy for cyclical mastalgia. 272 patients were enrolled into the study. Linear analogue charts and diary pain cards were used for assessment of response. Reduction in breast pain, heaviness, tenderness, and serum prolactin after 3 and 6 months' therapy were significantly greater with bromocriptine than with placebo. Improvement in symptoms with bromocriptine was maintained for at least 6 months after therapy. Overall 29% of patients dropped out while on therapy, more from the bromocriptine than from the placebo group. Adverse effects, especially nausea and dizziness, were commoner among the bromocriptine-treated patients, but blood pressure was unaffected.
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PMID:European multicentre trial of bromocriptine in cyclical mastalgia. 196 67

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

During a 5 year period 62 patients requesting post coital contraception were give 2 doses of 200 mg danazol for 5 days after being informed of possible side effects and about the lack of experimental data on its effectiveness. All patients were advised to make notes about side effects, spotting, and the nature, quantity, and duration of menstrual flow, 35 of the women were nulliparae and 27 pluriparae aged 16 to 42, 52 had had unprotected sexual activity and 10 rupture of the condom that motivated them to seek contraception. Nausea occurred in 18, headache in 3, and mastodynia in 5 cases. 57 patients reported regular, 2 early, and 3 late menstruation. Hypomenorrhea occurred in 3 and menorrhagia in 9 cases. The administration of danazol took place between the 11th and 15th day of the menstrual cycle, but it proved ineffective in 1 case when the drug was given on the 20th day, however, this may have been attributable to previous unprotected sex. Danazol proved to be a good post-coital contraceptive with a high rate of efficacy and good tolerability. Treatment exceeding 5 days produced only a minor emotional tension in 4 patients.
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PMID:[Danazol: an alternative in postcoital contraception]. 273 38

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

Menopausal women receiving 0.625 mg/day conjugated oestrogen continuously for 6 mth were also given either 10 mg/day dydrogesterone continuously or 20 mg/day for the first 12 days of each calendar month in order to evaluate both the efficacy and the tolerance of each regimen. The following parameters were assessed: subjective symptoms, bleeding patterns, lipid metabolism, glycaemia, weight and blood pressure. Of the 81 patients who entered the study, 60 opted for the continuous treatment and 21 for the cyclic treatment. Seven (7) patients dropped out, 6 for administrative reasons and 1 because of nausea. The two groups were comparable with regard to all parameters, with the exception of the duration of pretreatment amenorrhoea, which was longer in the continuous-treatment group (40.6 vs. 19.1 mth), and the initial lipid profile levels, which were higher in the same group. The subjective symptoms were influenced rapidly and positively by both treatments. The other parameters remained unchanged, except for a clinically insignificant rise in triglycerides in both groups. Both treatments were quite satisfactorily accepted by the patients, in spite of a 70% rate of withdrawal bleeding in the cyclic group and a 40% rate of spotting in the continuous-treatment group. Sixty-two (62) patients remained free of side effects, while mastodynia was reported in 9 cases.
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PMID:Comparison of two equine oestrogen-dydrogesterone regimens in the climacteric. 304 26

A phase I study was performed on a newly developed antitumor agent, Bestrabucil (KM 2210). The study was started at an initial dose of 1 n 25 mg/body, and gradually increased up to 32n 800 mg/body. With single (35 patients) and five-consecutive-day (36 patients) administration, the dose-limiting factor was found to be tarry stool, remarkable decrease in hemoglobin content, and strong nipple and breast pain. The maximum tolerated dose (MTD) was concluded to be around 700 to 800 mg/body. With long-term administration (the longest term, 20 weeks, 36 patients), the dose-limiting factor was concluded to be a decrease in the peripheral leukocyte count when the total amount administered reached about 10 g. Side effects on the alimentary system due to this agent, such as vomiting, nausea and anorexia, were observed. In addition, mastalgia and genital bleeding due to released estrogen were also seen, especially in the case of long-term administration.
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PMID:[Phase I study of bestrabucil (KM 2210)]. 375 19


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