Results of a 5-year contraceptive trial in parous and nulliparous women with a new LNG-IUS.
| Title: | Results of a 5-year contraceptive trial in parous and nulliparous women with a new LNG-IUS. |
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| Authors: | Wildemeersch D; a Reproductive Health Consultant Intrauterine Devices and Systems , Ghent , Belgium.; Goldstuck ND; b Department of Obstetrics and Gynaecology , Faculty of Medicine and Health Sciences, Stellenbosch University and Tygerberg Hospital , Western Cape , South Africa , and.; Jackers G; c Applied Controlled Release, Technology Park , Ghent , Belgium. |
| Source: | Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology [Gynecol Endocrinol] 2017 Mar; Vol. 33 (3), pp. 223-226. Date of Electronic Publication: 2017 Jan 13. |
| Publication Type: | Comparative Study; Journal Article; Observational Study |
| Language: | English |
| Journal Info: | Publisher: Informa Healthcare Country of Publication: England NLM ID: 8807913 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1473-0766 (Electronic) Linking ISSN: 09513590 NLM ISO Abbreviation: Gynecol Endocrinol Subsets: MEDLINE |
| Imprint Name(s): | Publication: London : Informa Healthcare; Original Publication: [Carnforth, Lancashire ; Park Ridge, N.J.] : Parthenon Pub., [c1987- |
| MeSH Terms: | Contraceptive Agents, Female/*administration & dosage ; Intrauterine Devices, Medicated/*adverse effects ; Levonorgestrel/*administration & dosage; Abdominal Pain/etiology ; Abdominal Pain/prevention & control ; Levonorgestrel/adverse effects ; Uterine Hemorrhage/etiology ; Uterine Hemorrhage/prevention & control ; Adolescent ; Adult ; Belgium ; Contraception Behavior ; Device Removal ; Female ; Follow-Up Studies ; Humans ; Intrauterine Device Expulsion ; Lost to Follow-Up ; Middle Aged ; Parity ; Patient Acceptance of Health Care ; Pregnancy ; Pregnancy, Unplanned ; Prospective Studies ; Young Adult |
| Abstract: | Objective: To report on the contraceptive performance and continuation of a new T-shaped LNG-IUS, releasing 20 μg of levonorgestrel/day, in both parous and nulliparous nulliparous women after 5 years of use.; Materials and Methods: An observational prospective contraceptive study conducted in parous and nulliparous women up to 48 years of age.; Results: The study was conducted in a sample size of 356 women of whom 67.1% were parous and 32.9% were nulliparous with mean age of 35.1 (range 15-48). The total cumulative observation period was 27 269 woman-months. Only one accidental pregnancy was observed and two expulsions were reported with no partial expulsions. There were 12.7% medical removals for abnormal bleeding, pain and other medical reasons, mostly not related to the use of the LNG-IUS, and 13.3% removals in women wishing to become pregnant. The discontinuation rate at 5 years amounts to 25.7% including women with pregnancy wish, who used the LNG-IUS for an average of 44 months. There were no serious adverse events (e.g. perforation, pelvic inflammatory disease).; Conclusion: The LNG-IUS used in this study is highly effective and well tolerated resulting in a high continuation of use. The only two expulsions that occurred during the study is remarkable. The ease and safety of insertion together with optimal retention is considered an advance in intrauterine contraceptive device technology. |
| Contributed Indexing: | Keywords: Contraception efficacy; Femilis LNG-IUS; levonorgestrel; safety 5-year continuation |
| Substance Nomenclature: | 0 (Contraceptive Agents, Female); 5W7SIA7YZW (Levonorgestrel) |
| Entry Date(s): | Date Created: 20170114 Date Completed: 20170906 Latest Revision: 20260127 |
| Update Code: | 20260130 |
| DOI: | 10.1080/09513590.2016.1276164 |
| PMID: | 28084114 |
| Database: | MEDLINE |
Comparative Study; Journal Article; Observational Study