A comparative study of Depo-Provera® versus Norethisterone acetate in management of endometrial hyperplasia without atypia

Document Type : Original Article

Author

1 Consultant (Assistant Professor) Obstetrics and Gynecology Department, Zagazig University Students’ Hospital, Zagazig, Egypt

2 Obstetrics and Gynecology Department, Zagazig University Faculty of Medicine, Zagazig, Egypt

Abstract

Background: The objective of this study was to assess effectiveness
and safety of Depo-Provera® (Medroxyprogesterone acetate - MPA)
in treatment of endometrial hyperplasia (EH), and to compare it with
Norethisterone acetate (NETA) as an oral progestogen treatment.
Methods: This was a prospective randomized trial where 146 women aged 35-50 years with abnormal uterine bleeding who were diagnosed as having EH were randomized to receive either Depo-Provera; one injection every 3 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 which was analyzed by intention to
treat. Secondary outcome variables were side effects of treatment,
persistence/progression of EH during follow-up period.
Results: After 6 months treatment, Depo-Provera was more successful in achieving regression of non-atypical EH than NETA [67 out of
73 women (91.8%) vs. 49 out of 73 (67.1%), respectively], and the
difference between the two groups was statistically significant (RR:
1.37; 95% CI: 1.15-1.63, p = 0.048*). Adverse effects were relatively common with moderate differences between the two groups.
Conclusions: This study showed that Depo-Provera is an effective
and safe treatment for EH without atypia. Given its availability, apparent safety, and relatively reduced cost, Depo-Provera® deserves
to be considered in further larger-sized, multi-centre, double blind,
randomized, placebo-controlled trials prior to recommending it for
routine use in women with EH.

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