Trial Information

Abnormal Uterine Bleeding in Women With Uterine Leiomyomas: Open Randomized Clinical Trial Of Non Inferiority Between Oral Dienogest, Oral Desogestrel and Subcutaneous Goserelin

Uterine leiomyoma is a very prevalent condition among women and, although it is mainly
asymptomatic, it may be related to bothersome or debilitating symptoms, such as uterine
bleeding and pelvic pain or pressure. The standard treatment is surgical (hysterectomy or
myomectomy), but there has been continued interest on medical treatments. Progestagens have
long been used to control bleeding associated to leiomyomas, but they have not been able to
decrease myoma volume. GnRH analogs are well stablished agents, capable of controlling
symptoms and decreasing the tumors´volume, but their use is limited by bone loss and
menopausal symptoms. A newly introduced progestagen, dienogest, has been studied to treat
endometriosis, but its effects on leiomyoma are only starting to be assessed. The
investigators are aiming to compare dienogest with the GnRH analog goserelin and the
progestagen desogestrel in a randomized trial to see how this new treatment compares with
previously used drugs and whether it is similar, inferior or superior to them on controlling
leiomyoma associated symptoms and decreasing leiomyoma volume.