GNRH Antagonist monotherapy vs Add-back therapy in Abnormal Uterine Bleeding with Leiomyoma(AUB-L)- An open label randomized control trial assessing clinical and skeletal outcomes

This study is a randomized controlled trial designed to compare the efficacy of oral GnRH antagonist (elagolix) monotherapy versus elagolix with add-back therapy (estradiol and norethindrone acetate) in women aged 18–50 years with abnormal uterine bleeding due to leiomyoma (AUB-L). Uterine fibroids are a common cause of heavy menstrual bleeding and significantly impair quality of life, especially in low-resource settings where surgical management is often overused.

Eligible participants with ultrasound-confirmed fibroids and normal baseline bone mineral density will be randomized into two treatment arms and followed for six months. The primary outcomes include reduction in menstrual blood loss, improvement in hemoglobin levels, and changes in bone mineral density measured by DEXA scan. Secondary outcomes include assessment of side effects, pain scores, quality of life, and changes in fibroid size.

The study aims to generate region-specific evidence on the effectiveness of GnRH antagonist therapy with and without add-back treatment, highlighting a safe, non-surgical, fertility-preserving option for managing AUB-L while minimizing bone loss and improving overall quality of life.