The effectiveness of desogestrel for endometrial protection in women with abnormal uterine bleeding-ovulatory dysfunction: a non-inferiority randomized controlled trial

Nisarath Soontrapa, Manee Rattanachaiyanont, Malee Warnnissorn, Thanyarat Wongwananuruk, Suchada Indhavivadhana, Prasong Tanmahasamut, Kitirat Techatraisak, Surasak Angsuwathana, Nisarath Soontrapa, Manee Rattanachaiyanont, Malee Warnnissorn, Thanyarat Wongwananuruk, Suchada Indhavivadhana, Prasong Tanmahasamut, Kitirat Techatraisak, Surasak Angsuwathana

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).

Conflict of interest statement

The authors declare no competing interests.

© 2022. The Author(s).

Figures

Figure 1
Figure 1
CONSORT participant flow. DSG desogestrel, MPA medroxyprogesterone acetate.
Figure 2
Figure 2
Histopathology of endometrial response after treatment. (a) Complete transformation showing a small inactive gland with pseudodecidual stromal change, (b) Proliferative endometrium without response, (c) Inadequate secretory change and inconspicuous pseudodecidual stromal change.

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