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  • Title: Clinical and endocrinologic study of continuous levonorgestrel administration from subcutaneous solid polydimethylsiloxane rods.
    Author: Roy S, Stanczyk F, Mishell DR, Lumkin M, Gentzschein E.
    Journal: Contraception; 1980 Jun; 21(6):595-615. PubMed ID: 6775868.
    Abstract:
    Three solid polydimethylsiloxane (Silastic) rods containing levonorgestrel were inserted into the subcutaneous tissue of the volar aspect of the forearm of 8 women. Serum samples were drawn three times a week for 2 months and weekly thereafter for 2 years in 3 of the subjects. The other subjects had serum drawn during the twelfth and last treatment months. Levonorgestrel, estradiol and progesterone were measured in all samples. The subject kept a bleeding record. In comparison to an earlier clinical trial in which 6 hollow capsules of Silastic filled with levonorgestrel were used, the 3 solid levonorgestrel-containing rods provided higher serum levels of levonorgestrel, fewer serum estradiol peaks, only a single episode of ovulation and better bleeding performance. 8 human volunteers were tested to determine the efficacy of delivering levenorgestrel by a polydimethsiloxane subcutaneous rod inserted in the forearm. Average daily relesse rate of levonorgestrel was calculated. There was a marked variation in the bleeding patterns among the study group; for example 1 subject was amennorheic after the first month, whereas another had almost continuous spotting and bleeding during the first 3.5 months of the study. The average serum levonorgestrel values per month of treatment for 3 subjects studied for this endocrine parameter for 1 year showed peak semum levonorgestrel levels of 3.6, 2, and 1.6 ng/ml in the first month. Thereafter, serum levonorgestrel fell precipitously, reaching relatively constant levels of 1.4, .9, and .5 ng at 4, 3 and 5 months, declining to .4 ng after the end of the 2-year clinical trial. In comparison to an earlier clinical trial in which 6 hollow capsules of Silastic filled with levonorgestrel were used, the 3 solid rods provided higher serum levels of levonorgestrel, fewer serum estradiol peaks, only 1 ovulation episode, and overall better bleeding performance.
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