Table 2.
Secondary and other endpoints related to bleeding, uterine volume, and fibroid-related quality of life.
| Endpoint measured | Placebo |
Elagolix 300 mg BID |
Elagolix 300 mg BID + add-back therapy |
||||||
|---|---|---|---|---|---|---|---|---|---|
| Women with uterine fibroids and coexisting adenomyosis (N = 34) | Women with uterine fibroids without adenomyosis diagnosis at baseline (N = 161) | Overall pooled study population (N = 195) | Women with uterine fibroids and coexisting adenomyosis (N = 32) | Women with uterine fibroids without adenomyosis diagnosis at baseline (N = 167) | Overall pooled study population (N = 199) | Women with uterine fibroids and coexisting adenomyosis (N = 60) | Women with uterine fibroids without adenomyosis diagnosis at baseline (N = 332) | Overall pooled study population (N = 392) | |
| Proportion of women with suppression of bleedinga at the final monthb | 1/30 (3.3) | 6/145 (4.1) | 7/175 (4.0) | 23/28 (82.1)f | 128/147 (87.1)f | 151/175 (86.3)f | 35/55 (63.6)f | 172/297 (57.9)f | 207/352 (58.8)f |
| Proportion of women with amenorrhea at the final monthb | 1/30 (3.3) | 6/145 (4.1) | 7/175 (4.0) | 23/28 (82.1)f | 121/147 (82.3)f | 144/175 (82.3)f | 34/55 (61.8)f | 143/297 (48.1)f | 177/352 (50.3)f |
| Mean change from baseline to month 6 for uterine volume by TAU/TVU, cm3c | 65.7 (41.3) | 46.1 (71.2) | 47.8 (60.1) | -109.4 (39.7)e | -49.0 (74.1) | -57.0 (61.6) | -48.9 (28.7)d | -28.0 (50.6) | --32.0 (42.5) |
| Mean UFS-QOL score change from baseline to month 6c | |||||||||
| Symptom severity | −15.6 (3.7) | −8.0 (1.8) | −9.1 (1.6) | −53.6 (3.9)f | −47.7 (1.8)f | −48.8 (1.7)f | −47.8 (2.7)f | −35.1 (1.3)f | −37.0 (1.2)f |
| HRQL total | 17.6 (3.8) | 7.4 (1.8) | 8.9 (1.6) | 58.5 (3.8)f | 45.2 (1.9)f | 47. 3 (1.7)f | 51.1 (2.7)f | 37.8 (1.3)f | 39.9 (1.2)f |
Statistical comparisons were not made between adenomyosis subsets.
BID = twice daily; HRQL = health-related quality of life; TAU/TVU = transabdominal/transvaginal ultrasound; UFS-QOL = Uterine Fibroid Symptom and Health-Related Quality of Life.
Four women who were randomized and treated before the trial registration date were excluded from this analysis. Statistical significance compared with placebo was indicated by dP<.05,eP<.01, and fP<.001. Final month was defined as the last 28 days before and including the last treatment period visit date. If data on menstrual blood loss (measured using the alkaline hematin method) that could be evaluated were available between the last treatment period visit date and the last dose date, then the last dose date was used.
Suppression of bleeding was defined as no bleeding during the final month, with or without spotting.
Data are presented as n/N (%) where N, the denominator, is the number of women with at least 38 days on study drug before and including day 1 of treatment. Statistical significance compared with placebo was on the basis of the Cochran–Mantel–Haenszel test using study as stratification factor.
Data are presented as least-squares mean (standard error of the mean). Statistical significance compared with placebo was determined by pooling the results from an ANCOVA model with treatment and study as the main effects and baseline as a covariate.