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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

Following a brief review of the progressive improvements in oral contraceptive (OC) formulations and a description of the multicenter international study of Triella, this article describes a French multicenter double-blind study which compared the triphasic OC Triella with the widely used biphasic pill Adepal. Triella combines a constant dose of 35 mcg ethinyl estradiol (EE) with norethisterone doses of .5 mg for 7 days, .75 mg for 7 days, and 1 mg for 7 days. 91 women used Triella for a total of 463 cycles and 87 used Adepal for 412 cycles. There were no statistically significant differences in the age, height, weight, blood pressure or previous OC usage of the 2 groups. Average menstrual cycle length and duration of menstruation were both shortened after OC use, from 30.16 to 27.6 days and 4.74 to 3.65 days with Triella and from 30.49 to 27.6 days and 4.85 to 3.59 days with Adepal. Some diminution of menstrual flow was also observed. Spotting or staining was observed during 14.0% of days in the 1st cycle and 2.0% in the 6th cycle with Triella and during 11.9% of days in the 1st cycle and 3.9% in the 6th cycle with Adepal. Before treatment, during the 1st cycle, and during the 6th cycle respectively, 48.4%, 9.9%, and 4.8% of women using Triella and 65.5%, 11.4%, and 8.9% using Adepal experienced dysmenorrhea, while 45.1%, 12.1%, and 6.3% using Triella and 57.5%, 13.8%, and 10.7% using Adepal experienced premenstrual syndrome. There were no statistically significant changes in weight. Mean blood pressure did not show any tendency to increase with Triella after a temporary rise in the 1st 2 cycles, which was not statistically significant. Average blood pressure with Adepal increased from 118.6/70.9 before treatment to 121.4/71.6 in the 6th cycle. 3.3% of Triella users and 9.2% of Adepal users had blood pressure increases to 140/90 or above. Among cycles of Triella and Adepal use respectively, 6.9% and 8.3% had breast problems, 6.2% and 5.6% had digestive problems, 6.9% and 3.6% had abdominopelvic problems, 5.4% and 4.9% had headaches, 3.2% and 4.6% had leucorrhea, 1.9% and 3.6% had psychic problems, .9% and 1.5% had vascular problems, and .6% and .7% had skin problems. All side effects had a tendency to decline with use. No new anomalies were detected in the final gynecological examination, except a case of mastosis in an Adepal user. 20 Triella users and 23 Adepal users were evaluated before treatment and at the 3rd, 6th, and 12th cycle for triglycerides, fasting and postprandial insulin and glucose tolerance, and total cholesterol. There were no significant changes, although there were nonsignificant postprandial elevations in glucose and insulin with both formulations. There were slight declines in total cholesterol with both OCs. No pregnancies occurred in either group.
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PMID:[Triella: a French multicenter double blind clinical study]. 1228 Feb 13

35 predominantly multiparous, sexually active women aged 25-44 years were fitted with levonorgestrel 20 T (Schering) IUDS in the post- menstrual phase, or in rare instances, right after abortion. the devices contained 60 mg of levonorgestrel releasing 20 mcg/day with the life span of 5 years. The patients were followed up every 3-6 months to detect side effects and complications. The first year contained a total of 339 months of observation, while the figure rose to 461 months in the second year. Spotting lasting 15-20 days followed insertion, but in later months only 7% of patients complained of bleeding or menstrual spotting. 7-8% of cases tended to have oligomenorrhea in the first year; 1/3 to 1/2 of them had hypomenorrhea during the first and second year. True amenorrhea started in 20-30% of women, persisting through both years. Longer duration of flow occurred in 32.4-4.57.1% of cases during these 2 years. Hormonal effects (headache, acne, hirsutism, depression, mastalgia, and inflamed varicose veins) ranged from 18.2- 33.3%. Levonorgestrel 20 T demonstrated more superior contraceptive efficacy than Progestasert; however, serious menstrual cycle disorders associated with it also increased. All progestin-releasing devices (the minipill, Norplant, Progestasert) induced menstrual changes, thus their use is preferable for therapeutic indications such as hypermenorrhea and uterine fibroid.
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PMID:[Two-year clinical performance of the Levonorgestrel 20 T IUD]. 1231 72

This report summarizes a meeting of the IPPF International Medical Advisory Panel (IMAP) held in November, 1986, at which information on steroidal oral contraception (OC), Acquired Immunodeficiency Syndrome (AIDS), and female sterility were discussed. Regarding the multiphasic OC now in use, the benefits to health and well-being outweigh the possible side-effects and infrequent complications. Use is associated with a lower incidence of pelvic inflammatory disease, 96-98% effective prevention of pregnancy, a protective effect against ovarian and endometrial cancer, and regulation of erratic menstrual cycles. Minor side effects include nausea, vomiting, dizziness, headache, fluid retention, and inter-menstrual spotting. Adverse effects are circulatory system disease, myocardial infarction, venous thromboembolism, elevated blood pressure, and liver disease. Data on possible carcinogenicity have been conflicting. For women over age 40 OCs should be prescribed with caution. IMAP also drew up recommendations to assist FPAs to play a more active role in controlling the spread of AIDS. An effective program of Information and Education is of primary importance, targeting family planning workers and clients, teachers, parents, and employers. Wide promotion of condom use is a priority. Studies in Africa have revealed a major epidemic of AIDS, with the major mode of transmission heterosexual. The only immediate practical step in prevention of spread is by changes in sexual behavior. The last topic discussed is that of sterility in African women. The naturally occurring level of infertility expected in all populations of women is 3%; high levels in Africa vary by region from 3-32%. These levels of sterility are acquired through infection with Neisseria gonorrheae and Chlamydia trachomatis. Silent infection of women with Chlamydia make treatment especially difficult.
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PMID:Statement on steroidal oral contraception. 1234 Sep 76


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