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

During October 1988-April 1990, clinicians randomly allocated 783 healthy women attending six family planning centers and outpatient gynecological clinics in urban areas of Thailand to either the group using a 30 mcg ethinyl estradiol (EE) combined oral contraceptive (OC) with 150 mcg desogestrel (DSG) (394 women) or an OC with 75 mcg gestodene (GSD) (389 women). Researchers aimed to evaluate the efficacy and acceptability of these two third-generation OCs. After six cycles of OC use, the continuation rate was 87.6% for DSG/EE and 85.9% for GSD/EE. No one from either group became pregnant. Women forgot to take the pills during 1.8% of the cycles with DSG/EE and 2% of the cycles with GSD/EE. Breakthrough bleeding was more common than spotting in both groups (0.8-5.4% vs. 0.6-2% for DSG/EE; 0.8-4.4% vs. 0-4.4% for GSD/EE), while in Caucasian women spotting was more common. Breakthrough bleeding and spotting rates were comparable in both groups. Irregular bleeding initially increased, then fell with time. Irregular bleeding for both OC groups was less common than it is in Northern European women. No one experienced any serious side effects. The most common minor side effects were nausea, headache, and breast tenderness. The incidences increased in the first cycle, then fell. They were comparable for both groups. Acne was less frequent after OC use (20.7% at baseline vs. 17.1% at 6 months for DSG/EE and 22% at baseline vs. 16.9% at 6 months for GSD/EE). Neither OC influenced the mean body weight or the mean blood pressure. These findings indicated that both OCs are very effective, provide excellent cycle control, and produce a low incidence of side effects. They also protect against acne.
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PMID:Multicenter trial of two monophasic oral contraceptives containing 30 mcg ethinylestradiol and either desogestrel or gestodene in Thai women. 779 87

Although an association between oral contraceptives (OCs) and arterial hypertension has been well-documented, most studies have found only mild or moderate hypertension with reversal to normal levels 3 months after OC discontinuation. This paper presents two cases in which young women developed severe left ventricular hypertrophy and renal failure due to OC-induced malignization of hypertension. The first patient, a 23-year-old, was admitted to the hospital with a 3-day history of headache, mental confusion, and aggressiveness. 6 months before presentation, severe arterial hypertension had been diagnosed. At that time, she was advised to discontinue OCs (30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel), which she had been taking for a year; she did not comply with this directive. The second patient, 21 years old, was admitted with accelerating hypertension. She had initiated OC use (30 mg of ethinyl estradiol and 150 mcg of levonorgestrel) 6 months earlier. 3 months after starting OC use, she developed headache and fatigue. Both women had a hemorrhagic cerebral accident as a complication of malignant hypertension. All neurologic, renal, and cardiovascular complications were reversible after OC discontinuation. OC-related malignant hypertension can be averted through effective control of blood pressure in OC users.
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PMID:Cardiac and neurologic complications in malignant hypertension due to oral contraceptive use. 786 96

Physicians recruited 882 women into a multicenter trial of a new biphasic oral contraceptive (OC) (25 mcg + 125 mcg desogestrel and 40 mcg + 30 mcg ethinyl estradiol). Trial sites were in Belgium, Denmark, Finland, France, Germany, Norway, Sweden, and the former Yugoslavia. After 3 cycles, women who had switched from using another OC in the 2 months before the study (switchers) were less likely to continue the new OC than were women who had not used any OC in the last 2 months (starters) (6 cycles = 87.2% vs. 90.6%, 12 cycles = 74.7% vs. 79.5%; and 18 cycles = 59.8% vs. 64.9%). Withdrawal bleeding did not occur in 3.2% of all cycles. Absence of withdrawal bleeding became less common over time (cycle 1 = 7.6%, cycle 3 = 5%, cycle 6 = 3.2%, and cycle 18 = 1.8%). Duration of withdrawal bleeding was no more than 5 days in 80% of all women. More and more women had no more than 5 days of withdrawal bleeding as time passed (cycle 1 = 81.7%, cycle 6 = 85.6%, and cycle 18 = 90.6%). Irregular bleeding was more common in the first cycles of the study than in subsequent cycles (e.g., spotting during cycles 1-3 = 8.5-4.8% vs. 3.7-3.1% during cycles 6-18). By cycle 18, 96% of all women had no irregular bleeding. The drop-out rate for irregular bleeding was 2.2% at the end of the study. In 5% of cycles, at least 1 tablet was forgotten. In the first cycles, starters were somewhat more likely to complain of nausea, headache, and breast tenderness than switchers (e.g., nausea, cycle 1 = 5.8% vs. 3.4%). The gap between the 2 groups disappeared after 3 cycles. Starters were more likely to have minor complaints before OC use than after OC use (e.g., 6.5% fewer frequencies of headaches at 18 months). These findings show that the new OC has very good cycle control and a agreeable side effect profile.
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PMID:Cycle control and side effects of a new combiphasic oral contraceptive regimen. 794 27

At 66 sites in Denmark, Italy, New Zealand, and the UK, clinicians randomly allocated 1006 women 30 years old, some of whom were in their early 50s, into 1 of 2 groups receiving a low-dose oral contraceptive (OC): Minulet containing 75 mcg gestodene (GES)/30 mcg ethinyl estradiol (EE) and Mercilon containing 150 mcg desogestrel (DES)/20 mcg EE. The study aimed to compare these 2 low-dose OCs to help physicians prescribe an OC that could be continued into later years. Before treatment, the 2 groups had similar demographic and gynecologic characteristics. The mean menstrual flow length in the GES/EE group was longer than that of the DES/EE group (4.7 days vs. 4.5 days; p = .035) though. None of the women during 2800 cycles of GES/EE use and 2796 cycles of DES/EE use conceived, even though women forgot to take at least 1 pill in 11% of cycles. The GES/EE OC had significantly better cycle control than did the DES/EE OC. For example, the GES/EE group was more likely to have normal cycles than the DES/EE group (84-93% vs. 73-83%; p .001). The DES/EE group experienced a significantly lower withdrawal bleeding mean intensity than the GES/EE group in all 6 cycles, but the bleeding for both groups was close to light bleeding. The 2 groups were similar in weight, blood pressure, Papanicolaou smears, and laboratory data. Discontinuation rates for the GES/EE and DES/EE groups were 13.5% and 12.8%, respectively. Adverse reactions accounted for discontinuation in 7% of the GES/EE group and 8% of the DES/EE group. The major complaints leading to discontinuation were headache, nausea, and breakthrough bleeding. Both GES/EE and DES/EE had very good cycle control and efficacy and a very low rate of side effects. These results suggest that both these low-dose OCs would be acceptable for healthy nonsmoking women needing contraception up to menopause.
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PMID:Clinical comparison of two low-dose oral contraceptives, Minulet and Mercilon, in women over 30 years of age. 813 24

Breakthrough bleeding as a side effect of oral contraceptive (OC) use is considered one of the primary causes if discontinuation of oral contraceptives. In this study, the incidence and pattern of vaginal bleeding is examined and correlated with biologic responses and plasma steroid bioavailability. Between October 1, 1985 and October 15, 1987, subjects were randomly selected from eligible women beginning OC use as patients of the Department of Gynecology and Obstetrics at the Johns Hopkins Medical Institutions. Women were grouped by type of OC as follows: 1) 67 women taking 50 micrograms of ethinyl estradiol and 1.0 mg of norethindrone (OC1);l 2) 61 women taking 35 micrograms of ethinyl estradiol and 1.0 mg of norethindrone (OC2); and 3) 64 women taking 35 micrograms of ethinyl estradiol and .5 mg of norethindrone (OC3). Estrogen and progesterone concentrations in plasma were measured on the 21st day during the third, sixth, and ninth cycles. The samples was taken 24 hours after ingestion of the pill for day 20, and 1 hour after taking the pill on day 21. An extensive interview was also conducted for all study participants. Bleeding was recorded for any amount of bleeding occurring during days 2 through 21, and during days 21 through 28. Cycles were omitted where pills had been forgotten by the patient. An initial slope was calculated with the 1 hour value level and subtracting the 0 hour level over the actual time interval. Linear regression analysis was used to compare the slopes and bleeding days. Of the 316 women enrolled, 61% (192) completed the study. The findings were that the incidence of intermenstrual bleeding was not statistically different among the various preparations. For 59 patients eliminated from the study, 24% experienced intermenstrual bleeding. Those lose to follow-up were not among those unwilling to tolerate their bleeding pattern. There was similar incidence of other side effects among all three preparations: .5% amenorrhea of dysmenorrhea, 7% nausea, 16% headache, 26.5% depressed mood, 16.6% breast tenderness, and 44.3% acne. The low-dose OC3 had the statistically highest rates of intermenstrual bleeding. The bleeding patterns are described. Bleeding patterns were higher than those previously reported in the literature. Further research might focus on controlling for factors such as hormone-binding globulin capacity.
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PMID:A randomized trial of three oral contraceptives: comparison of bleeding patterns by contraceptive types and steroid levels. 831 16

After the development of monophasic combined oral contraceptives (COCs), containing a fixed dose of estrogen and progestogen, biphasic and triphasic COCs were introduced in the 1980s; in these the dose of ethinyl estradiol and progestogen changes during the pill cycle. In the so-called every day pills, the 21 pills of active steroid combination are followed by 7 inactive pills containing starch, iron, or bran. Method failures of OCs are among the lowest ranging from 0.2-1/100 woman-years. User failures can be as high as 6.2/100 women-years. The individual difference in peak plasma levels of estrogens in women taking identical OCs can be 10-fold. Conditions that affect the bioavailability of contraceptive steroids are: 1) drug interaction (vitamin C, drugs that induce liver enzymes, and antibiotics); 2) vomiting; 3) vegetarianism; 4) missing pills; and 5) malabsorption. Metabolic effects of COCs pertain to carbohydrate metabolism, lipid metabolism, hemostasis, and vitamins. Prescribing of COCs involves counseling clients about contraindications to COCs, starting routines, and the pill-free interval, as well as follow-up and monitoring, the problem of missing pills, and selection criteria for OC use. Medical conditions in which COC use requires special consideration are sickle cell disease, trophoblastic disease, HIV disease, gallstones, epilepsy, valvular heart disease, oligomenorrhea/amenorrhea, inflammatory bowel disease, and surgery. Side effects of COCs may include depression, nausea, vomiting, headaches, urinary tract infection, and lower genital tract infections. 6 months after stopping the OC 1% of users become amenorrheic. Many of the common causes of amenorrhea, such as weight loss amenorrhea and polycystic ovarian disease, may be treated with the COC until the couple desires to have a baby. The new progestogens desogestrel, norgestimate, and gestodene are highly selective compared to first and second generation progestogens.
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PMID:Combined oral contraceptives: acceptability and effective use. 832 4

Researchers compared the efficacy, safety, and acceptability of a triphasic oral contraceptive (OC), Triquilar, with those of a monophasic OC, Lo-Femenal, among 1088 women attending clinics in Chile, the Dominican Republic, Ecuador, Sri Lanka, and the Sudan. Both OCs contained levonorgestrel and ethinyl estradiol. 90% of women in each group exhibited good user compliance. Only 1 unplanned pregnancy occurred in each group, and both pregnancies were attributed to user failure. The gross cumulative efficacy rates at 11 months were 0.3/100 woman-years for the triphasic OC and 0.2/100 woman-years for the monophasic OC. The continuation rate at 11 months was lower for Lo-Femenal than it was for Triquilar (80.8% vs. 84.6%), but the difference was not significant. The leading side-effect-related reason for discontinuation in both groups was headache. Another key reason for OC discontinuation in both groups was personal reasons, such as planning a pregnancy. Most women in both groups did not have menstrual complaints (78.8% for the Triquilar group and 77.1% for the Lo-Femenal group). Intermenstrual bleeding rates were low (7.6% for the Triquilar group and 9% for the Lo-Femenal group). Significant intercenter differences for women reporting intermenstrual bleeding and side effects (e.g., headaches) existed (p .05). Women from both groups at the clinic in the Sudan always had lower reports of intermenstrual bleeding than those at the other clinics. In fact, no woman discontinued OC use because of intermenstrual bleeding in the Sudan. Women in Sri Lanka reported fewer side effects than those in other countries, suggesting they could better tolerate OCs than the other women. This multicenter study's findings indicates that both Triquilar and Lo-Femenal are effective and safe. In addition, they exhibit good cycle control.
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PMID:A multicenter comparative trial of triphasic and monophasic, low-dose combined oral contraceptives. 833 88

Efficacy and acceptability of 2 combined oral contraceptive pills administered vaginally are summarized. This is the 1st collaborative trial published by the South to South Cooperation in Reproductive Health. 1055 women participated in 12,630 cycles, in 9 countries, from June 1988 to May 1991. The pills were commercially available tablets containing 50 mcg ethinyl estradiol and 250 mg levonorgestrel (Schering AG, Sao Paulo, Brazil), or 30 mcg ethinyl estradiol and 15 mcg desogestrel (Organon, Sao Paulo, Brazil). Subjects were aged 17-39 younger and of lower parity from Mexico and Dominican Republic and older from Egypt and China. All had at least 1 pregnancy. 675 participated for 6 months, 470 for 1 year, 364 for 18 months, and 210 for 2 years. The 1-year discontinuation rate averaged 47.01% for the levonorgestrel group and 56.33% for the desogestrel group (p = 0.0061); 2-year discontinuation rates were 48.01% and 69.36, respectively, explained in part by higher involuntary pregnancy rates and prolonged bleeding rates in the desogestrel group. The most common medical reasons for stopping contraception were unplanned pregnancy, vaginal or vulval irritation, nausea, vaginal discharge and headache. Vaginal irritation was reported by 1%, 9 in each group. There were 32 pregnancies, 14 in the levonorgestrel and 18 in the desogestrel group. 17 were in missed pill cycles and the rest were method failures, 6 in the levonorgestrel group and 9 in the desogestrel group. The Pearl index varied from 0 in Nigeria to 12.24 in Mexico, and was 2.45 for levonorgestrel vs. 3.74 for desogestrel. There was a wide variation in discontinuation rates by center: Brazil and China had few, while many women from Dominican Republic, Mexico and Zambia left the study. Bleeding problems were common complaints, more so in the desogestrel group. There were 363 women with intermenstrual bleeding (only once in 80%), 148 with spotting (only twice in 65%). Bleeding duration was significantly less in pill cycles than baseline, pressure. Women gained an average of 1 kg over 2 years, more in the desogestrel group. The pregnancy rate of 2.78 is within the range reported for levonorgestrel rings.
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PMID:Comparative study on the efficacy and acceptability of two contraceptive pills administered by the vaginal route: an international multicenter clinical trial. 842 36

The question of whether the pharmacokinetics of ethinyl estradiol (EE2) is affected differently by the progestins in low-dose combined oral contraceptives containing gestodene or desogestrel was revisited. 80 randomly allocated women took 30 mcg EE2 and either 75 mcg gestodene or 150 mcg desogestrel for the first 21 days of each cycle for 6 months. Blood samples taken on days 1, 10, and 21 of the 1st, 3rd and 6th cycle, at frequent times for 24 hours after pill intake, were analyzed for EE2, corticosteroid binding globulin, cortisol and 6beta-hydroxycortisol. 31 women in each group completed the study. Minor side effects such as headache, breast tension, acne, and nausea occurred in each group; 1 subject dropped out because of headache, nausea, and hypermenorrhea and 1 because of a hematoma. No significant differences were seen in serum EE2 levels including the rise in mean EE2 on days 1-10, or the smaller rise between days 10-21, or the pharmacokinetic parameters Cmax, tmax, area under the curve (AUC) at 0-4 hours, or AUC at 0-24 hours. There was a maximal variation of 11% in intracyclical increases in serum EE2, but no change in intercyclical variations. There were also no significant differences between groups in the expected estrogen-induced increase in corticosteroid binding globulin. Urinary hydroxycortisol increased slightly over each cycle, somewhat more in the 1st cycle, and a bit more in the desogestrel cycles than in gestodene cycles, but not significantly. This study was contrasted in detail with the reports that prompted the controversy over pharmacokinetics of estradiol during intake of the involved combined pills. The import of the assays for cortisol metabolites is the fact that estradiol and cortisol are metabolized by the same liver cytochrome P450 isoenzyme.
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PMID:Influence of gestodene and desogestrel as components of low-dose oral contraceptives on the pharmacokinetics of ethinyl estradiol (EE2), on serum CBG and on urinary cortisol and 6 beta-hydroxycortisol. 846 17

A leading patient complaint is headaches which tend to occur more often in women than men. Nonvascular headache is the most common and is caused by tension or muscle contraction. Oral contraceptives (OCs) do not affect nonvascular headaches. They can also be safely used in women who experience common migraines whose symptoms do not become more severe or frequent during OC use. On the other hand, women who have classic migraine (headache accompanied by focal neurologic symptoms) or common migraine with symptoms becoming more severe or frequent during OC use should discontinue OC use. Instead, they should use a barrier method or the IUD. Estradiol treatment appears to be effective in treating menstrual migraine. Since the data are inconclusive about the effect of OCs on young women who have experienced a stroke or transient ischemic attacks, it would be best for them to use a barrier method. Most antiepileptic drugs (phenobarbital, phenytoin, paramethadione, and carbamazepine) cause enzyme induction which may be linked to decreased levels of estrogen and increases in irregular bleeding, thereby increasing the likelihood of an epileptic OC user becoming pregnant. Possible contraceptive failure exposes a developing fetus to the teratogenic properties of the antiepileptic drugs. Thus, physicians should prescribe OCs with 50 mcg of ethinyl estradiol rather than 35 mcg ethinyl estradiol. Epileptic women can also use Depo-Provera, because it is not only effective in preventing pregnancy but reduces seizure frequency. It is important for any contraceptive method chosen for epileptic women to be effective because pregnancy intensifies seizures which in turn can damage the mother and/or fetus and cause neonatal distress.
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PMID:Contraceptive methods for women with neurologic disorders. 851 48


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