Continuous Low Dose Norethindrone as an Oral Contraceptive Agent
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Norethindrone 0.5 mg alone was taken daily by 82 women for a total of 4, 058 weeks (1, 014.5 cycles) in order to investigate the efficacy and the acceptability of continuous low dosage progestogens as an oral contraceptive agent. Each participant was instructed to take one tablet daily without interruption, beginning the initial tablet on the 5th or 6th day of menstrual cycle, but thereafter taking the medication continuously regardless of any vaginal bleeding. The longest period of administration was 102 weeks. In this study, one pregnancy occurred. Subsequently, pregnancy rate of 1.2 per 100 women years for a total use was obtained. A high incidence of menstrual irregularity and/or amenorrhea was recongnized. The peak of distribution in cycle length was 25-30 days, but there was considerable variation. Such irregularity of cycle length or amenorrhea caused some women to desire the discontinance of this method. The avarage duration of vaginal bleeding was 4.6 days, and there was no significant difference between the control and treated cycle. However, wider variation in the duration of vaginal bleeding was noted in the treated cycle. Menstrual flow was not markedly decreased as compared with that of the control cycle. There was a decrease in the quantity of menstrual flow in 37.9% and no chage in 50.7%. Basal body temparature was recorded in 436 cycles. Basal body temparature in the treated cycle showed irregular or monophasic curves in 86.7%. while 13.2% had biphasic curves. Nausea and vomiting under the treatment occurred in a very low incidence. Other side effects observed were weight changes, especially its gain, headache, and lumbago, but were occurred infrequently.Liver-function tests were carried out at regular intervals. Abnormal values were observed in following examinations;BSP in 7.7%, GOT in 2.6%, GPT in 3.9%, Meulengracht's index in 2.3%, direct bilirubin in 18.2%, indirect bilirubin in 1.3% and TTT in 5.2%. These incidence of abnormal levels returned to normal levels during or after discontinance of the medication. There were no abnomal cases except hypertension in 2 cases.Endometrial biopsies were made in the treatment. Endometrium, obtained from the patient who was administered the mini pill for a period of 80 days continuously, showed many grandular elements and slight edema without decidua like transformation in the stroma. The glandular epithelium disclosed
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