Efficacy of ormeloxifene versus oral contraceptive in the management of abnormal uterine bleeding due to uterine leiomyoma

Aim: To compare ormeloxifene with combined oral contraceptive (COC) in abnormal uterine bleeding (AUB) due to leiomyoma (AUB-L). Methods: Fifty women with AUB-L were randomized after informed consent and institute ethics clearance. Group I (n = 25) was given ormeloxifene (a SERM i.e. selective estrogen receptor modulator) 60 mg twice per week and group II (n = 25) was given COC (ethinyl estradiol 30 mu g with desogestrel 150 mu g) on days 1-21 for 6 months. Menstrual blood loss was assessed on pictorial blood loss assessment chart (PBAC) score and leiomyoma volume was assessed on ultrasound. Fibroids were classified according to FIGO-PALM-COEIN classification for AUB where leiomyomas were further sub-classified as types 0 to 8 according to their location. Follow up was done at 1, 3, 6 and 9 months. Results: Mean PBAC score reduced by 81% with ormeloxifene (group I) compared with 43.8% for COC (group II). After 6 months, 18 patients (72%) in group I had PBAC score in the non-menorrhagic range (<100) compared with only two (8%) in group II. In group I, PBAC score in FIGO-PALM-COEIN leiomyoma types 2, 3, 4, 5, 6 reduced by 90.2%, 82.5%, 93.3%, 56.4% and 100%, respectively and 14 (56%) developed amenorrhea; compared with reduction of 64%, 27.5%, 25.9% in types 4, 5 and 6, respectively in group II. Dysmenorrhea visual analog scale score decreased in both groups. Mean leiomyoma volume increased in both groups: by 25.7% with ormeloxifene versus 16.9% with COC; only grade 2 leiomyoma in group I reduced by 44%. One patient in group II with grade 2 leiomyoma discontinued treatment at 3 months. Seven patients (28%) developed ovarian cyst in group I with no other major adverse effect in either group. Conclusion: Ormeloxifene with its convenient twice-weekly dosage schedule was effective in treating AUB-L, with 72% of patients responding to 6-month treatment compared with 8% with COC, even though leiomyoma volume increased insignificantly with both ormeloxifene and COCs.