The results of a Chinese study of the progestin dienogest build on data from a multicenter European study of the progestin in teens with endometriosis. Published in The Journal of Women’s Health, the trial showed that the drug was well-tolerated and superior to placebo in reducing endometriosis-related pain.
A dosage of 2 mg of dienogest given once daily was evaluated in the randomized, double-blind, placebo-controlled multicenter study. A total of 255 Chinese women aged 18 to 45 with laparoscopically diagnosed endometriosis were enrolled, all of whom had an endometriosis-associated pelvic pain score (EAPP) ≥ 30 mm on a 0 to 100 mm visual analog scale.
The primary outcome was absolute change in the EAPP from baseline to week 24. Secondary variables included proportions of responders and intake of supportive analgesic medication. The researchers also evaluated adverse events (AEs), laboratory parameters, and bleeding patterns. Bone mineral density (BMD) also was evaluated in a subset of 140 women.
A statistically significant difference in mean reduction in EAPP was seen in women treated with dienogest after week 24 compared to the placebo group (-24.54 mm; 95% CI -29.93 to -19.15; P < 0.0001). Secondary efficacy analyses supported the significant superiority of dienogest over placebo. Few AEs were associated with treatment with the progestin and it had no effect on BMD levels.