Dysfunctional Uterine Bleeding Clinical Trial
Official title:
The Effectiveness of Cyclic Desogestrel Therapy for Abnormal Uterine Bleeding Associated With Anovulation: a Non-inferiority Double Blinded Randomized Control Trial
The objectives of the present study is to determine the effectiveness of cyclic desogestrel
(DSG) compared with cyclic medroxyprogesterone acetate for the treatment of anovulatory
dysfunctional uterine bleeding (DUB) in the following aspects:
1. Endometrial histopathology changes
2. Menstrual cycle control.
Anovulatory dysfunctional uterine bleeding (DUB) is the most common cause of abnormal uterine
bleeding especially in postmenarcheal adolescent, perimenopausal women, patient with
polycystic ovary syndrome (PCOS) and in obese women. Aims of treatment in women with
anovulatory DUB are to restore the natural control mechanism of endometrium (introduce normal
synchronous growth, development, shedding of a structural stable endometrium) and to prevent
endometrial hyperplasia. The two main treatment options are estrogen-progestin therapy and
progestin therapy. Women who are sexually active and not immediately prepared to pursue
pregnancy are best manage by estrogen-progestin treatment especially combined oral
contraceptive pills (COCs) but in perimenopausal women, obese women or women who can't
tolerate COCs or have contraindications in using COCs, cyclic progestin will be the treatment
of choice. Common used progestin in anovulatory DUB is medroxyprogesterone acetate (MPA) 5-10
mg/day for 10-14 days each month. This progestin has strong progestogenic effect but has some
undesirable effect such as glucocorticoid effect, mineralocorticoid effect and androgenic
effect. Long term using this progestin especially in obese women or perimenopausal women who
have risk for diabetes mellitus and dyslipidemia may be negative effect to glucose and lipid
metabolism. DSG is the third generation progestin with no glucocorticoid, mineralocorticoid
effect and low androgenic effect may be the better choice of treatment but the data of DSG in
treatment of anovulatory DUB us scanty. So this study will evaluate the effect of cyclic DSG
in endometrial histology changing and lipid, glucose metabolism in patient with anovulatory
DUB.
Comparison : Women with anovulatory DUB are randomized into two groups, receiving a course of
either cyclic DSG or cyclic MPA. The main outcome measured is to compare the effect of both
interventions on endometrial histology changing.
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