[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]. [Article in Chinese]
Author(s): Fu Y(1), Mi W, Li L, Zhang H(2), Wang J, Cheng W, Sun L, Li L, Xie S, Zhang J.
Affiliation(s): Author information:
(1)Peking University Institute of Mental Health, Beijing 100191, China. (2)Email:
sally_zhy@sina.com.
Publication date & source: 2014, Zhonghua Fu Chan Ke Za Zhi. , 49(7):506-9
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.
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