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 23,468 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

More widespread availability of emergency contraceptive methods has the potential to drastically reduce unwanted pregnancy. At present, only 3% of women use such methods and only 10% know how to obtain them; another 25-30% are unaware of this option. Use of the regimens is indicated in cases of rape, unprotected intercourse, and contraceptive mishaps such as condom breakage or skipping more than two oral contraceptive pills. Currently available regimens include 200 mcg of ethinyl estradiol and 2 mg of levonorgestrel taken in a split dose within 72 hours of unprotected intercourse, 0.75 mg of levonorgestrel taken within 8 hours of intercourse and repeated in 24 hours, 2-3 doses of 800 mg of the synthetic androgen danazol started within 72 hours of unprotected sex, insertion of a copper IUD, and a single dose of 600 mg of RU-486 within 72 hours; high doses of estrogen are no longer recommended due to serious side effects. Pregnancy rates range from 0.2-2.3% in users of combined estrogen and progesterone to 0.0-0.1% for the copper IUD and RU-486. The main side effects associated with these methods include nausea, vomiting, breast tenderness, and disruption of the menstrual cycle. Given the safety, simplicity, and effectiveness of these postcoital methods, it is recommended that all family planning programs make emergency contraception available.
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PMID:Emergency contraception. 789 64

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

Many women in the Netherlands depend on a postcoital contraceptive (PCC) method in situations of unprotected intercourse. The incidence rate for abortions and for adolescent pregnancies in the Netherlands is the lowest worldwide. Dutch society matter-of-factly accepts adolescent sexuality and provides formal and informal sex education and readily accessible contraceptive services. Emergency contraception should be administered within 72 hours after unprotected intercourse (e.g., rape or incest) or mechanical contraceptive failure. Administration of 5 mg ethinyl estradiol (EE) for 5 days as a PCC first occurred in the Netherlands in 1964, and PCC usage peaked at 55,000 in 1975. Side effects of EE include, in order of frequency, nausea, vomiting, tender breasts, and menorrhagia. Possible modes of action for EE are more rapid transport of fertilized ova through the oviduct and slowed maturation of the endometrium, resulting in suppressed implantation. The Yuzpe PCC method involves 4 tablets of a combined oral contraceptive (each tablet with 50 mcg EE + 250 mcg levonorgestrel) administered within 72 hours followed by 2 tablets 12 hours later. Side effects are similar to those of EE alone, as is the effectiveness rate. A dose of 0.75 mg levonorgestrel alone is as effective at preventing pregnancy as the Yuzpe regimen. Side effects are considerably less common with the levonorgestrel regimen than the Yuzpe regimen. For women who present more than 72 hours after and less than 7 days after unprotected intercourse or for those with contraindications to estrogen, a copper-releasing IUD can serve as a PCC. A postcoital IUD can cause serious complications for women with a sexually transmitted disease, however. Taking RU-486 during the luteal phase of the menstrual cycle greatly drops plasma levels of progesterone and estradiol. Postovulatory administration of an antiprogestogen is the best PCC method because of minimal side effects and a high success rate.
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PMID:Emergency contraception: a review. 795 9

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

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

In the Dominican Republic, clinical researchers randomly assigned 150 users of the contraceptive implant Norplant who came to Profamilia's Family Planning Clinic in Santo Domingo complaining of bleeding irregularities to one of three treatment groups. They aimed to evaluate the effectiveness of a combined oral contraceptive (OC) with 250 mcg levonorgestrel and 50 mcg ethinyl estradiol (EE) and of 50 mcg EE alone in treating bleeding irregularities. Bleeding irregularities were defined as prolonged bleeding (i.e., 8 or more continuous days of bleeding or spotting) or irregular bleeding (i.e., current bleeding episode initiated after a bleeding-free interval of less than 15 days). Age, parity, duration of Norplant use, and length of bleeding episode before treatment were similar in all three groups (i.e., OC, EE, and placebo). The OC group was significantly more likely to experience ceased bleeding within three days than the two other groups (91% vs. 67% for EE group [p 0.01 from OC group] and 15% for placebo group [p 0.0005 from both treatments]). Bleeding lasting for at least one week occurred less often in the OC group than the two other groups (2% vs. 14% for EE group and 50% for placebo group [p 0.0005 for both treatments]). Duration of bleeding was significantly lower in the OC group than the other two groups (2.6 days vs. 5.4 days for EE group and 12.3 days for placebo group; p 0.0001). Even though women in both hormonal treatment groups were more likely to experience gastralgia or nausea than the placebo group (33-40% vs. 4%; p 0.005), the side effects rarely interrupted treatment. These findings suggested that the OC is a very good effective treatment for bleeding irregularities and is a practical treatment since it is available at all Profamilia clinic sites.
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PMID:Hormonal treatment for bleeding irregularities in Norplant implant users. 863 69


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