Performance and acceptability of intrauterine release of levonorgestrel with a miniature delivery system for hormonal substitution therapy, contraception and treatment in peri and postmenopausal women

Abstract

Objective: To evaluate the performance and acceptability of a novel intrauterine drug delivery system, FibroPlant-levonorgestrel (LNG), delivering approximately 14 μg per day. Subject and designs: A 1-year prospective clinical trial in 141 peri and postmenopausal women, including women with heavy or postmenopausal bleeding and women needing contraception. The majority received percutaneous 17β-estradiol (Oestrogel), 1.5 mg daily. Clinical results and ultrasonographic effects were evaluated. Results: Eighty-three insertions were done in perimenopausal women and 58 in postmenopausal women followed-up for 8–38 months. Fifty-two perimenopausal (64%) and virtually 100% of the postmenopausal women developed amenorrhoea, with occasional slight spotting. Eleven women with heavy bleeding, five of them with single or multiple intramural and subserosal fibroids of 3–6 cm or more, were all successfully treated, except one. There were no pregnancies. Conclusion: This study of 1 432 women-months of use suggests that the frameless FibroPlant-LNG IUS is safe, well tolerated and effective in suppressing the endometrium during EST. The fact that the IUS also acts as a contraceptive, and significantly reduces menstrual bleeding, as demonstrated in earlier studies, is of added importance.