Evaluation of a unique oral contraceptive in the treatment of premenstrual dysphoric disorder

Ellen W. Freeman, Robin Kroll, Andrea Rapkin, Teri Pearlstein, Candace Brown, Kelly Parsey, Paul Zhang, Harji Patel, Marie Foegh

Research output: Contribution to journalArticle

143 Citations (Scopus)

Abstract

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 μg) 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 PMDD (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.

Original languageEnglish (US)
Pages (from-to)561-569
Number of pages9
JournalJournal of Women's Health and Gender-Based Medicine
Volume10
Issue number6
DOIs
StatePublished - Jan 1 2001

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Oral Contraceptives
Placebos
Premenstrual Syndrome
Spironolactone
Diagnostic and Statistical Manual of Mental Disorders
Ethinyl Estradiol
Luteal Phase
Acne Vulgaris
Appetite
Progestins
Therapeutics
Depression
Food
Equipment and Supplies
Premenstrual Dysphoric Disorder
Calendars

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Evaluation of a unique oral contraceptive in the treatment of premenstrual dysphoric disorder. / Freeman, Ellen W.; Kroll, Robin; Rapkin, Andrea; Pearlstein, Teri; Brown, Candace; Parsey, Kelly; Zhang, Paul; Patel, Harji; Foegh, Marie.

In: Journal of Women's Health and Gender-Based Medicine, Vol. 10, No. 6, 01.01.2001, p. 561-569.

Research output: Contribution to journalArticle

Freeman, EW, Kroll, R, Rapkin, A, Pearlstein, T, Brown, C, Parsey, K, Zhang, P, Patel, H & Foegh, M 2001, 'Evaluation of a unique oral contraceptive in the treatment of premenstrual dysphoric disorder', Journal of Women's Health and Gender-Based Medicine, vol. 10, no. 6, pp. 561-569. https://doi.org/10.1089/15246090152543148
Freeman, Ellen W. ; Kroll, Robin ; Rapkin, Andrea ; Pearlstein, Teri ; Brown, Candace ; Parsey, Kelly ; Zhang, Paul ; Patel, Harji ; Foegh, Marie. / Evaluation of a unique oral contraceptive in the treatment of premenstrual dysphoric disorder. In: Journal of Women's Health and Gender-Based Medicine. 2001 ; Vol. 10, No. 6. pp. 561-569.
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