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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

Three sequential oestradiol valerate (E2V) and cyproterone acetate (CPA) combinations based on 11 days of oestrogen and 10 days of oestrogen-progestogen administration were investigated during hormone replacement therapy in two prospective, double-blind randomized trials. Treatment A comprised 2 mg E2V and 1 mg CPA, treatment B, 1 mg and 0.5 mg and treatment C, 2 mg and 2 mg, respectively. During treatment A hot flushes (P < 0.0001), night sweating (P < 0.0001), depression (P = 0.0001), dizziness (P = 0.0001) and insomnia (P = 0.003) decreased significantly. The only side effect was breast tenderness, which was experienced by 18% of the women. Weight and blood pressure, thyroid, adrenal, liver and kidney functions, parathyroid hormone and vitamin D, platelets and blood cell counts did not change during the 12 months of therapy. In the women who received treatment A the menstrual flow became less abundant during the early months of treatment (P < 0.0001), the menses being scanty in around 30% of the women, while some 10% had amenorrhoea. Spotting occurred in 10-20% of the subjects. Endometrial biopsies were atrophic in 10% of the women, whereas a normal secretory phase was observed in 45% and irregular secretion in 45%. After careful analysis using visual analog scales, these findings were interpreted as indicating a high-normal progestational effect. In comparison with the pattern observed in normal menstrual cycles the women who received treatment A had a more heterogenic glandular epithelium, with more papillae, larger stromal cells, a more pronounced decidual reaction and more fibrinoid material. No cases of hyperplasia were seen. Treatment B was less effective than treatment A in relieving climacteric complaints. Irregular bleeding was troublesome in over 20% of cases and amenorrhoea occurred in 50%. Endometrial biopsies were atrophic in 57% of the women. The effectiveness of treatment C in alleviating flushes, sweating, dizziness and depression was the same as that of treatment A. The decrease in menstrual flow during the early months and the incidence of amenorrhoea (approx. 10%) and atrophic endometria (approx. 10%) were comparable. Detailed analysis revealed that C had an even stronger progestational effect than A. It was concluded that A was the treatment of choice in comparison with B and C. It proved highly effective in treating climacteric complaints, had no side effects apart from breast tenderness, provided good cycle control and induced a physiological secretory transformation of the endometrium.(ABSTRACT TRUNCATED AT 400 WORDS)
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PMID:Endometrial effects during hormone replacement therapy with a sequential oestradiol valerate/cyproterone acetate preparation. 838 51

One single silastic capsule containing nomegestrol acetate, Uniplant, was inserted subcutaneously in 100 women of reproductive age who desired to avoid conception. Insertions and removals of the capsules were made in the gluteal region following intracutaneous local anesthesia with 2% procaine. Eighty women completed one year of use. Eleven women bore the implant for 6-11 months. A total of 1,085 women-months were recorded. One pregnancy occurred, resulting in a Pearl Index of 1.1. Bleeding episodes similar to menstruation occurred in all women but the degree of regularity varied from subject to subject. Amenorrhea developed in the range of 14-18% during the first six months of use but declined to less than 10% during the last six months. Menorrhagia likewise was higher in the first six months (18% in the first month) but fell to less than 10% during the last six months. Spotting was 5% or less. Of the twenty women who did not complete one year of use, nine discontinued because they found other methods were either more practical or less revealing. Three discontinued because of bleeding irregularities, three desired to become pregnant, one became pregnant. Other complaints included dizziness, headache, increased blood pressure, loss of libido, painful breasts and nausea. Over half of the women indicated their desire to continue using the single implant as a contraceptive.
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PMID:One year contraception with a single subdermal implant containing nomegestrol acetate (Uniplant). 843 5

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