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  • Title: Progestogen-only microdose followed by estrogen-progestogen combination, a new approach to oral contraception.
    Author: Russowsky M, Sartoretto JN.
    Journal: Contraception; 1982 Jul; 26(1):41-9. PubMed ID: 7128133.
    Abstract:
    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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