Kurunmäki H, Toivonen J, Lähteenmäki P, Luukkainen T
Contraception. 1981 May;23(5):473-85. doi: 10.1016/0010-7824(81)90075-5.
Twenty-one women used a levonorgestrel-releasing intracervical contraceptive device, which was designed to release 20 microgram/ay. The devices were inserted after cessation of menstrual bleeding. Patterns of bleeding and clinical performance wer evaluated and plasma concentrations of levonorgestrel, estradiol and progesterone in selected subjects were measured by radioimmunoassay. The results of the initial 90-day treatment are presented. Levonorgestrel was detected in peripheral plasma by 30 minutes after insertion of the device. Considerable variation of plasma levonorgestrel concentrations was observed between subjects, but within each subject, the plasma level of levonorgestrel was very stable with time. Of 24 cycles monitored by blood sampling, 19 were ovulatory. One subject did not ovulate at all. During the first 30-day period of treatment, frequent intermenstrual bleeding or spotting periods occurred. Two spontaneous expulsions occurred 9 and 22 days after insertion. Both of these subjects were nulligravidas. Side-effects were few and no pregnancies occurred during the study period.
21名女性使用了一种释放左炔诺孕酮的宫颈内避孕装置,该装置设计为每天释放20微克。这些装置在月经出血停止后插入。评估了出血模式和临床表现,并通过放射免疫测定法测量了部分受试者血浆中左炔诺孕酮、雌二醇和孕酮的浓度。本文给出了最初90天治疗的结果。在装置插入后30分钟即可在外周血浆中检测到左炔诺孕酮。受试者之间观察到血浆左炔诺孕酮浓度存在相当大的差异,但在每个受试者体内,左炔诺孕酮的血浆水平随时间非常稳定。在通过采血监测的24个周期中,19个周期有排卵。一名受试者根本没有排卵。在治疗的前30天内,频繁出现经间期出血或点滴出血期。插入后9天和22天发生了两例自发排出。这两名受试者均为未孕女性。副作用很少,并且在研究期间没有发生妊娠。