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Query: UMLS:C0312414 (Spotting)
 88 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Clinical experience with a low dose oral contraceptive (OC) containing .5 mg norethisterone and .035 mg ethinyl estradiol is reported. 1168 sexually active women received the OC as a 21-day cyclic regimen from 1 to 53 cycles with an overall total of 16345 cycles. No pregnancies occurred when the OC was taken as directed. 3 women who conceived during the study missed 3, 2, and 1 prescribed tablets, respectively. The overall pregnancy rate was .22/100 woman years of use calculated as a Pearl index. Spotting and/or breakthrough bleeding was noted primarily in the early cycles. Patient dropout was 14.2% for menstrual disorders and irregularities, and 11.4% for other medically associated complaints or reactions. It is concluded that this OC has proved to be an effective and well-tolerated lower dose OC.
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PMID:Clinical experience with a low dose oral contraceptive containing norethisterone and ethinyl oestradiol. 71 Jan 78

The reliability and the overall clinical acceptance of a new combined oral contraceptive, containing 30 mcg of ethinyl estradiol and 0.15 mg of D-norgestrel, was studied in 102 patients over 1,731 cycles. The results have been accumulated over a period of four years, some of the subjects still using the presented formulation. No pregnancy occurred during the observation period. Out of the totally observed cycles, 94.3 per cent had a duration of 28 +/- 2 days. In only 1.7 per cent of the cycles did withdrawal bleeding fail to appear. Spotting and breakthrough bleeding occurred 3.6 and 3.8 per cent of the cycles respectively. The incidence of side-effects reported by the users and commonly associated with oral contraceptive use was relatively low.
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PMID:Four years overall experience with a new low estrogen -- low progestogen oral contraceptive. 78 48

Pregnon is a new low-dosage ovulation-inhibiting agent containing 1 mg of lynestrenol and .05 mg of ethinyl estradiol in each tablet. It is also marketed under the name of Pregnon 28 or Ovostat 28 in which each package contains 22 active plus 6 placebo tablets. Data were collected from Belgian clinics and evaluated by the Medical Unit of Organon in Belgium and the Netherlands. During this study, 639 women of fertile age were monitored through 9159 cycles. The maximum period of treatment was 36 cycles. Clinical and gynecological examinations were made before treatment and then every 2 or 3 months. Treatment was begun by taking the 1st tablet on the 1st day of menstruation. After taking 22 tablets there was a 6-day tablet-free interval during which withdrawal bleeding usually occurred. The intensity of the withdrawal bleeding was normal in 57.3%, slight in 41.7%, and heavy in 1%. Spotting was noted in 3.1% of the cycles and breakthrough bleeding occurred in 2.9%. Usually they occurred in the first 3 cycles. Amenorrhea was observed in 2.9% of the cycles. Body weights were relatively unchanged. Blood pressures remained the same. Side effects were headache, nausea, vomiting, breast tenderness, heavy legs, leucorrhea, nervousness, depression, and decreased libido. Only 46 patients discontinued treatment because of these drug effects yielding an acceptability level of about 93%. Since no pregnancies occurred during this study, the Pearl index was 0.
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PMID:Clinical evaluation of a new oral contraceptive, 'Pregnon'. 114 83

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

Highlights of papers presented at an international symposium on advantages and risks of oral contraceptives, and the details of the results of 2 studies are discussed. 1 study compared the effects of a combination of 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel with a reduced dose 3-phase combination of these hormones; it involved 489 women with 2777 menstrual cycles for a 6-month period. No pregnancies occurred. Missed menstruation occurred in 0.9% of the cycles with the 3-phase combination, contrasted with 2.3% of the 30/150 mcg combination group. Bleeding disorders were more frequent in the 30/150 pill group (15.7% vs. 10.1%). Spotting occurred in 8% of cases in both groups. The 3-phase pills proved to be safe and were preferred because they caused less bleeding. Another study compared the effects of 2 Swedish-made contraceptives by administering Neovletta (N) to 50%, Trionetta (T) to 25%, and Trionetta 28 (T 28) to another 25% of the 862 women with 6472 menstrual cycles who participated at 12 family planning centers in Sweden. T and N contain the same amount of estrogens, but T contains 40% less gestagen than N. The T 28 treatment also included 7 placebo tablets. Results showed that only 1 pregnancy occurred in the T group, despite a high rate of failure to take the pills (8.1-9.4%). Menstruation was normalized in both the N group (90.4%) and the T group (94.2%) reaching the normal 28 (+ or - 2) days cycle. Missed menstruation occurred in 0.6% of the T group as opposed to 2.3% of the N group. There was a significant difference in spotting and irregular bleeding between the 2 groups: 6.3%-15.8% for N and 3.0-9.0% for T. Also, there was a higher rate of bleeding problems for T 28 than for T. 8.6-8.8% of women in both groups quit the experiment because of complications, e.g., bleeding, nausea, headache, and hypertension. Both pills proved to be reliable and safe, but the new 3-phase preparation, T, is recommended because it does not reduce the beneficial HDL cholesterol as does N.
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PMID:[Report from an international symposium about advantages and risks of oral contraceptives. Amsterdam, March 1982]. 692 Nov 98

The advantages of the microdose progestogen-only approach to contraception include: low hormonal intake, non-inhibition of ovulation, and nonadministration of exogenous estrogen. Results of pilot trials with 2 regimens are reported. Medication A was given to 80 women and consisted of 30 mcg levonorgestrel taken daily on days 5-14 of the menstrual cycle, followed by a combination of 500 mcg norgestrel with 50 mcg ethinyl estradiol taken daily on days 15-24. The Medication B group (101 women) took 30 mcg levonorgestrel on days 5-14 and 150 mcg levonorgestrel with 30 mcg ethinyl estradiol daily on days 15-24. Detailed medical histories and physical and laboratory examinations were used to screen patients with contraindications to hormonal contraceptives. The patients in both groups were young healthy married women, all had previous pregnancies, and the majority were white. The women kept diaries of pill intake, sexual intercourse, bleeding, and symptoms and returned for follow-up monthly for 6 months. 493 cycles were studied for Medication A and 792 with Medication B. In 36 patients in the Medication B group, measurements of high density lipoproteins and cholesterol were taken on admission and on the 21st day of the 3rd and 6th cycles. For Medication A, a total of 179 days (1.8%) of intermenstrual bleeding was reported. Breakthrough bleeding was reported by 27.5% of the patients, occurring in 6.5% of the cycles. Spotting for this group was reported by 26.3% in 6.1% of the cycles. For Medication B, 210 days (1.4%) of intermenstrual bleeding was reported. Breakthrough bleeding was reported by 25.7% of the group in 4.4% of the cycles; 13.9% reported spotting in 4.0% of the cycles. 3 patients in each group discontinued for medical reasons including headache and nervousness in the Medication A group, and breakthrough bleeding in the Medication B group. 2 pregnancies occurred in the Medication B group, each patient had missed the 10th microdose tablet and 1 also missed the 9th tablet. For all symptoms (e.g., headache, nervousness, dysmenorrhea) more women reported the occurrence of the symptom before treatment than during treatment. The mean values for cholesterol and high density lipoproteins in the 36 sampled patients remained within normal range but small decreases were noted. Better cycle control was suggested with Medication B but the results were not submitted to statistical analysis because the groups were small and not random. The data also suggest that the incidence of intermenstrual bleeding might be reduced by the administration of 1 additional combination tablet in each cycle. Further investigation is needed for clarification.
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PMID:Progestogen-only microdose followed by estrogen-progestogen combination, a new approach to oral contraception. 712 33

The efficacy, cycle control, subjective complaints, and safety of monophasic preparations of the oral contraceptives containing gestodene 75 mcg plus ethinyl estradiol 30 mcg versus desogestrel 150 mcg plus ethinyl estradiol 30 mcg were compared in a 6-cycle, open-label, parallel, randomized, multicenter phase IV clinical study in Latin America. Of a total of 176 women in each group, 163 in the gestodene group and 160 in the desogestrel group completed 6 cycles, providing data for 1,015 and 1,006 cycles, respectively. Subject compliance was excellent; pills were missed during only 6.9% of the cycles in each group. No woman became pregnant during the study. Gestodene group exhibited significantly better cycle control as evidenced by the lower incidence of breakthrough bleeding and spotting. Spotting in some cycles was reported by 11.9% of women taking the gestodene-combination compared with 21% of women taking the desogestrel-combination. Based on number of women, 86.4% of the gestodene group reported all cycles were normal (no BTB) compared with 76.7% of the desogestrel group. Also, the women in the gestodene group reported a significantly lower incidence of nuisance side effects during treatment cycles. No amenorrhea was observed for either group. There were no clinically significant differences between groups with respect to body weight, blood pressure, or laboratory evaluations. Seven women withdrew from the gestodene group and 8 women withdrew from the desogestrel group because of adverse reactions. The results of this study indicate that, although both OCs provided effective contraception, in comparison to the desogestrel-combination, the gestodene-containing OC is associated with better cycle control, less bleeding, and fewer subjective complaints.
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PMID:Clinical comparison of monophasic oral contraceptive preparations of gestodene/ethinyl estradiol and desogestrel/ethinyl estradiol. Latin American Oral Contraceptive Study Group. 780 71

Spotting and bleeding are among the most common side effects associated with oral contraceptive (OC) use and their occurrence is a prime determinant of whether a new user will continue to use OCs. Desogestrel and gestodene are two new progestins that were developed in part to minimize the occurrence of these side effects. Assessing the effect of these progestins is difficult, however, in part because their effects may be subtle, requiring a large sample size and possibly being overshadowed by other factors. To address these issues, we analyzed data from two comparative multicenter clinical trials that included 15,421 cycles among 2767 women. One study compared 75 micrograms gestodene + 30 micrograms ethinyl estradiol (EE) with 150 micrograms desogestrel + 30 micrograms EE, the other compared the same gestodene preparation with 150 micrograms desogestrel + 20 micrograms EE. Both studies found a higher risk of spotting or bleeding in all cycles among users of the desogestrel-containing preparation, with the differences ranging between 20% and 70% higher for the first study and 40% and 140% in the second. These differences were statistically significant in four of six cycles in each study and persisted after controlling for consistency and recency of OC use as well as smoking. After pooling the data and controlling for estrogen dose, the desogestrel-containing preparation was significantly associated with more frequent spotting or bleeding in five of six cycles. Smoking and consistency and recency of OC use were also independent predictors of spotting or bleeding.
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PMID:The effect of desogestrel, gestodene, and other factors on spotting and bleeding. 883 84

The contraceptive efficacy, cycle control, and safety of a new low-dose oral contraceptive (OC) containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel were investigated in a multicenter clinical study involving 805 German women (average age, 25.6 years) and a total of 4400 treatment cycles. There was one case of method failure, yielding a Pearl index of 0.29. A regular withdrawal bleed occurred in 95.5% of all treatment cycles. Cycle length and the duration and intensity of withdrawal bleeding were not significantly altered by use of the low-dose OC. Spotting alone occurred in 12.4% of treatment cycles and breakthrough bleeding alone was reported in 4.5%; both symptoms occurred in 1.4% of cycles. Headache, breast tension, and nausea were reported by 17.3%, 11.0%, and 7.7% of women, respectively. Only 8.4% of women discontinued OC use due to adverse events. Finally, there were no clinically relevant changes in laboratory parameters, blood pressure, or body weight. Overall, these findings suggest that substantial reductions in the estrogen and progestogen doses of OCs do not compromise contraceptive efficacy or cycle control.
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PMID:A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 micrograms ethinyl estradiol and 100 micrograms levonorgestrel over six treatment cycles. 943 56

Manufacturers have steadily been decreasing the amounts of estrogen and progestin in oral contraceptives (OCs) in an effort to enhance safety and tolerability while preserving contraceptive efficacy. A new formulation containing 20 microg ethinyl estradiol (EE) and 100 microg levonorgestrel (LNG)--representing the lowest available contraceptive dose of each hormone--has undergone extensive clinical testing in the United States and Germany. A total of 1590 women in 61 centers received 20 microg EE and 100 microg LNG for 6 cycles. Overall, 4 pregnancies possibly related to treatment failure were reported, reflecting an overall Pearl Index (number of pregnancies per 100 woman-years of treatment) of 0.65 and a failure rate of 0.34%. Cycle control was typical of low-dose OC use. Spotting and breakthrough bleeding occurred most commonly during the earlier cycles in each study. Adverse events were typical of those seen with OC use and led to study discontinuation in 6.6% of the women. Intermenstrual bleeding was the cause for early study withdrawal in 2.6% of women. The study results suggest that the combination of 20 microg EE and 100 microg LNG offers the benefits of low hormone content with good contraceptive efficacy, cycle control, and tolerability.
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PMID:International clinical experience with a new low-dose, monophasic oral contraceptive containing levonorgestrel 100 microg and ethinyl estradiol 20 microg. 1009 Apr 29


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