Abstract
Women with chronic abnormal uterine bleeding-ovulatory dysfunction (AUB-O) are at increased risk of endometrial neoplasia. We conducted a non-inferiority randomized controlled trial to determine the effectiveness of two cyclic-progestin regimens orally administered 10 d/month for 6 months on endometrial protection and menstruation normalization in women with AUB-O. There were 104 premenopausal women with AUB-O randomized to desogestrel (DSG 150 µg/d, n = 50) or medroxyprogesterone acetate (MPA 10 mg/d, n = 54) group. Both groups were comparable in age (44.8 ± 5.7 vs. 42.5 ± 7.1 years), body mass index (24.8 ± 4.7 vs. 24.9 ± 4.7 kg/m2), and AUB characteristics (100% irregular periods). The primary outcome was endometrial response rate (the proportion of patients having complete pseudodecidualization in endometrial biopsies during treatment cycle-1). The secondary outcome was clinical response rate (the proportion of progestin withdrawal bleeding episodes with acceptable bleeding characteristics during treatment cycle-2 to cycle-6). DSG was not inferior to MPA regarding the endometrial protection (endometrial response rate of 78.0% vs. 70.4%, 95% CI of difference − 9.1–24.4%, non-inferiority limit of − 10%), but it was less effective regarding the menstruation normalization (acceptable bleeding rate of 90.0% vs 96.6%, P = 0.016).Clinical trial registration: ClinicalTrials.gov (NCT02103764, date of approval 18 Feb 2014).
Highlights
Women with chronic abnormal uterine bleeding-ovulatory dysfunction (AUB-O) are at increased risk of endometrial neoplasia
This study aimed to evaluate the effectiveness of cyclic DSG compared with cyclic MPA on endometrial protection and menstruation normalization in women with Abnormal uterine bleeding (AUB)-O
There is a lack of evidence from randomized controlled trials, especially about the effect of treatment for AUB-O on endometrial histopathology
Summary
Women with chronic abnormal uterine bleeding-ovulatory dysfunction (AUB-O) are at increased risk of endometrial neoplasia. There were 104 premenopausal women with AUB-O randomized to desogestrel (DSG 150 μg/d, n = 50) or medroxyprogesterone acetate (MPA 10 mg/d, n = 54) group Both groups were comparable in age (44.8 ± 5.7 vs 42.5 ± 7.1 years), body mass index (24.8 ± 4.7 vs 24.9 ± 4.7 kg/m2), and AUB characteristics (100% irregular periods). Despite the paucity of evidence from randomized controlled trials (RCT), the current treatment options include estrogen-progestin and progestin-only therapy[6] The former, in the form of combined hormonal contraceptives, is best for sexually-active women with a need for contraception[7]. This study aimed to evaluate the effectiveness of cyclic DSG compared with cyclic MPA on endometrial protection and menstruation normalization in women with AUB-O. We assessed the safety of these two progestins on metabolic parameters after 6 months of treatment
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