Efficacy and safety of a combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 μg in the treatment of premenstrual dysphoric disorder:a randomized, double blind placebo-controlled study / 中华妇产科杂志
Chinese Journal of Obstetrics and Gynecology
; (12): 506-509, 2014.
Article
в Zh
| WPRIM
| ID: wpr-454244
Ответственная библиотека:
WPRO
ABSTRACT
Objective To compare the efficacy and safety of a new low-dose oral contraceptive pill (YAZ) containing drospirenone 3 mg and ethinylestradiol 20 μg with placebo in reducing symptoms of premenstrual dysphoric disorder (PMDD). Methods This multicenter, double-blind, randomized clinical trial consisted of 2 run-in and 3 treatment cycles (84 days) with daily symptom charting; 187 women with symptoms of PMDD were randomized to either placebo group (n=94) or YAZ group (n=93), and assessed with daily record of severity of problems scale (DRSP) and clinical global impressions scale (CGI) before, during and after the treatments. Hormones were administered for 24 days, followed by 4 days of inactive pills. Results Compared with baseline level of DRSP, both groups got improvement after treatment; the YAZ group (median-28.7, range-82.5 to 2.3) had greater improvement than that in the placebo group (median-23.7, range-86.0 to 11.8), while there was not significant difference (P>0.05). The main adverse effects of YAZ included intermenstrual bleeding [13% (12/93) versus 3% (3/94)], menorrhagia [9% (8/93) versus 1%(1/94)], nausea [5%(5/93) versus 4%(4/94)] and skin rash [4%(4/93) versus 2%(2/94)]. Conclusions YAZ could improve symptoms of PMDD better than placebo, while without statistic significance in this study. The most common adverse effects are intermenstrual bleeding, menorrhagia, nausea and rash.
Полный текст:
1
База данных:
WPRIM
Тип исследования:
Clinical_trials
Язык:
Zh
Журнал:
Chinese Journal of Obstetrics and Gynecology
Год:
2014
Тип:
Article