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.
OBJECTIVE
To evaluate the performance and acceptability of a novel intrauterine drug delivery system, FibroPlant-levonorgestrel (LNG), delivering approximately 14 microg 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 17beta-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.


CONCLUSIONS
This study of 1432 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.
Wildemeersch
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Gynecologische Dienst, Piers de Raveschootlaan 125, 8300, Knokke, Belgium. dirk.wildemeersch@contrel.be
Schacht
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Wildemeersch
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D000328:Adult; D002979:Climacteric; D003267:Contraception; D016503:Drug Delivery Systems; D004343:Drug Implants; D005260:Female; D005500:Follow-Up Studies; D020249:Hormone Replacement Therapy / Q000379:methods*; D006801:Humans; D007436:Intrauterine Devices, Medicated; D016912:Levonorgestrel / Q000008:administration & dosage*; D008875:Middle Aged; D017698:Postmenopause; D011446:Prospective Studies; D013997:Time Factors; D014592:Uterine Hemorrhage / Q000188:drug therapy; D014599:Uterus
D004343:Drug Implants; D016912:Levonorgestrel