J Womens Health Gend Based Med. 2001 Jul-Aug;10(6):561-9
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J Womens Health Gend Based Med. 2001 Jul-Aug;10(6):561-9
Evaluation of a unique oral contraceptive in the treatment of premenstrual dysphoric disorder. Freeman EW,
PMS/PMResearch Group.
Department of Obstetrics/Gynecology, University of Pennsylvania,
Philadelphia, PA, USA. Premenstrual dysphoric disorder (PMDD) is a severe form
of premenstrual syndrome (PMS). This is the first trial of a unique oral
contraceptive containing a combination of drospirenone (DRSP, 3 mg) and ethinyl
estradiol (EE, 30 microg) for the treatment of PMDD. DRSP is a
spironolactone-like progestin with antiandrogenic and antimineralocorticoid
activity. Spironolactone has been shown to be beneficial in PMS, whereas oral
contraceptives have shown conflicting results. In this double-blind,
placebo-controlled trial, 82 women with PM(Diagnostic and Statistical Manual of
Mental Disorders, 4th ed. [DSM IV]) were randomized to receive DRSP/EE or
placebo for three treatment cycles. The primary end point was change from
baseline in luteal phase symptom scores as assessed on the Calendar of
Premenstrual Experiences (COPE) scale. Patients treated with DRSP/EE showed a
numerically greater change from baseline compared with those treated with
placebo on each of the 22 COPE items and each of the 4 symptom factors.
Between-group differences in symptom improvement reached statistical
significance in factor 3 only (appetite, acne, and food cravings, p = 0.027).
The secondary end points, Beck Depression Inventory (BDI) and Profile of Mood
States (PMS), were consistent with the primary end point in that patients
treated with the oral contraceptive showed a numerically greater improvement
from baseline compared with those treated with placebo. The results of this
study show a consistent trend in the reduction of symptoms that suggested a
beneficial effect of DRSP/EE for the treatment of PMDD, despite limitations of
the study design.
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