Depo-Provera Versus Norethisterone Acetate in Management of Endometrial Hyperplasia Without Atypia.

The objective of this study was to assess effectiveness and safety of Depo-Provera (medroxyprogesterone acetate) in treatment of endometrial hyperplasia (EH) and to compare it with norethisterone acetate (NETA) as an oral progestogen treatment. One hundred forty six women aged 35 to 50 years with abnormal uterine bleeding and diagnosed as having EH were randomized to receive either Depo-Provera, one injection every 3 months for 6 months (2 doses), or oral cyclic NETA, 15 mg daily for 14 days per cycle for 6 months. Primary outcome measure was regression of EH. Secondary outcome variables were side effects of treatment, persistence/progression of EH during follow-up period. After 6 months of treatment, Depo-Provera was more successful in achieving regression of nonatypical EH than NETA (67 [91.8%] of 73 women vs 49 [67.1%] of 73, respectively), and the difference between the 2 groups was statistically significant (relative risk: 1.37; 95% confidence interval: 1.15-1.63, P = .048*). Adverse effects were relatively common with moderate differences between the 2 groups. This is the first randomized study comparing Depo-Provera with an oral progestogen as a treatment for EH. Depo-Provera is an effective and safe treatment for EH without atypia.