Table 2. Summary of key clinical trials using LNG-IUS for endometrial protection in perimenopausal women.
| Study | Population, mean age (y) | No. of subjects | Treatment duration | Endpoints |
|---|---|---|---|---|
| Boon et al. [35] RCT (open-label) |
Perimenopausal; 46.9 (LNG-IUS), 46.8 (oral NETA) |
97 (LNG-IUS), 99 (oral NETA) |
2 y | Endometrial protection assessed by histology, bleeding pattern, efficacy, overall acceptability |
| Andersson et al. [37] RCT (open-label) |
Perimenopausal; 48.1 (LNG-IUS), 48.7 (oral HRT) |
18 (LNG-IUS), 19 (oral LNG 250 µg on day 11–21) |
1 y | Climacteric symptoms, bleeding pattern, endometrial protection assessed by histology |
| Depypere et al. [36] non-randomized (open-label) |
Peri/postmenopausal; 47.8 | 394 (contraception phase), 168 (ERT phase) | 9–48 mo contraception phase, 1–5 y ERT phase | Bleeding pattern, QoL, LNG-IUS continuation, adherence, tolerability |
| Suhonen et al. [38] non-comparative |
Peri/postmenopausal; 52 | 29 (LNG-IUS) | 38 mo | Endometrial protection assessed by histology and transvaginal ultrasound, bleeding pattern |
| Suhonen et al. [39,40] non-comparative |
Peri/postmenopausal; 51.4 | 36 (LNG-IUS) | 5 y | Endometrial protection assessed by histology |
LNG-IUS: levonorgestrel-intrauterine system, RCT: randomized controlled trial, NETA: norethindrone acetate, HRT: hormone replacement therapy, LNG: levonorgestrel, ERT: estrogen replacement therapy, QoL: quality of life.