Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder

Kimberly A. Yonkers, Candace Brown, Teri B. Pearlstein, Marie Foegh, Carole Sampson-Landers, Andrea Rapkin

Research output: Contribution to journalArticle

239 Citations (Scopus)

Abstract

Objective: To compare the efficacy of a new low-dose oral contraceptive pill (OCP) formulation with placebo in reducing symptoms of premenstrual dysphoric disorder. Methods: This multicenter, double-blind, randomized clinical trial consisted of 2 run-in and 3 treatment cycles with daily symptom charting; 450 women with symptoms of premenstrual dysphoric disorder were randomized to either placebo or an OCP formulation containing drospirenone 3 mg and ethinyl estradiol 20 μg. Hormones were administered for 24 days, followed by 4 days of inactive pills (24/4). Results: Scores on the total Daily Record of Severity of Problems decreased by -37.49 in the drospirenone/ethinyl estradiol group and by -29.99 in the placebo group (adjusted mean difference -7.5, 95% confidence interval [CI] -11.2 to -3.8; P < .001 by rank analysis of covariance). Mood symptom scores were reduced by -19.2 and -15.3 in active-treatment and placebo groups, respectively (adjusted mean difference -3.9, 95% CI -5.84 to -2.01; P = .003); physical symptom scores were reduced by -10.7 and -8.6 in active-treatment and placebo groups, respectively (adjusted mean difference -2.1, 95% CI -3.3 to -0.95; P < .001); and behavioral symptom scores were reduced by -7.7 and -6.2 in active-treatment and placebo groups, respectively (adjusted mean difference -1.5, 95% CI -2.251 to -0.727; P < .001). Response, defined as a 50% decrease in daily symptom scores, occurred in 48% of the active-treatment group and 36% of the placebo group (relative risk 1.7, 95% CI 1.1 to 2.6; P = .015) and corresponds to a number-needed-to-treat of 8 patients. Conclusion: A 24/4 regimen of drospirenone 3 mg and ethinyl estradiol 20 μg improves symptoms associated with premenstrual dysphoric disorder.

Original languageEnglish (US)
Pages (from-to)492-501
Number of pages10
JournalObstetrics and gynecology
Volume106
Issue number3
DOIs
StatePublished - Jan 1 2005

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Oral Contraceptives
Placebos
Ethinyl Estradiol
Confidence Intervals
Therapeutics
Numbers Needed To Treat
Behavioral Symptoms
Premenstrual Dysphoric Disorder
drospirenone
Randomized Controlled Trials
Hormones

All Science Journal Classification (ASJC) codes

  • Obstetrics and Gynecology

Cite this

Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder. / Yonkers, Kimberly A.; Brown, Candace; Pearlstein, Teri B.; Foegh, Marie; Sampson-Landers, Carole; Rapkin, Andrea.

In: Obstetrics and gynecology, Vol. 106, No. 3, 01.01.2005, p. 492-501.

Research output: Contribution to journalArticle

Yonkers, Kimberly A. ; Brown, Candace ; Pearlstein, Teri B. ; Foegh, Marie ; Sampson-Landers, Carole ; Rapkin, Andrea. / Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder. In: Obstetrics and gynecology. 2005 ; Vol. 106, No. 3. pp. 492-501.
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abstract = "Objective: To compare the efficacy of a new low-dose oral contraceptive pill (OCP) formulation with placebo in reducing symptoms of premenstrual dysphoric disorder. Methods: This multicenter, double-blind, randomized clinical trial consisted of 2 run-in and 3 treatment cycles with daily symptom charting; 450 women with symptoms of premenstrual dysphoric disorder were randomized to either placebo or an OCP formulation containing drospirenone 3 mg and ethinyl estradiol 20 μg. Hormones were administered for 24 days, followed by 4 days of inactive pills (24/4). Results: Scores on the total Daily Record of Severity of Problems decreased by -37.49 in the drospirenone/ethinyl estradiol group and by -29.99 in the placebo group (adjusted mean difference -7.5, 95{\%} confidence interval [CI] -11.2 to -3.8; P < .001 by rank analysis of covariance). Mood symptom scores were reduced by -19.2 and -15.3 in active-treatment and placebo groups, respectively (adjusted mean difference -3.9, 95{\%} CI -5.84 to -2.01; P = .003); physical symptom scores were reduced by -10.7 and -8.6 in active-treatment and placebo groups, respectively (adjusted mean difference -2.1, 95{\%} CI -3.3 to -0.95; P < .001); and behavioral symptom scores were reduced by -7.7 and -6.2 in active-treatment and placebo groups, respectively (adjusted mean difference -1.5, 95{\%} CI -2.251 to -0.727; P < .001). Response, defined as a 50{\%} decrease in daily symptom scores, occurred in 48{\%} of the active-treatment group and 36{\%} of the placebo group (relative risk 1.7, 95{\%} CI 1.1 to 2.6; P = .015) and corresponds to a number-needed-to-treat of 8 patients. Conclusion: A 24/4 regimen of drospirenone 3 mg and ethinyl estradiol 20 μg improves symptoms associated with premenstrual dysphoric disorder.",
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AU - Yonkers, Kimberly A.

AU - Brown, Candace

AU - Pearlstein, Teri B.

AU - Foegh, Marie

AU - Sampson-Landers, Carole

AU - Rapkin, Andrea

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N2 - Objective: To compare the efficacy of a new low-dose oral contraceptive pill (OCP) formulation with placebo in reducing symptoms of premenstrual dysphoric disorder. Methods: This multicenter, double-blind, randomized clinical trial consisted of 2 run-in and 3 treatment cycles with daily symptom charting; 450 women with symptoms of premenstrual dysphoric disorder were randomized to either placebo or an OCP formulation containing drospirenone 3 mg and ethinyl estradiol 20 μg. Hormones were administered for 24 days, followed by 4 days of inactive pills (24/4). Results: Scores on the total Daily Record of Severity of Problems decreased by -37.49 in the drospirenone/ethinyl estradiol group and by -29.99 in the placebo group (adjusted mean difference -7.5, 95% confidence interval [CI] -11.2 to -3.8; P < .001 by rank analysis of covariance). Mood symptom scores were reduced by -19.2 and -15.3 in active-treatment and placebo groups, respectively (adjusted mean difference -3.9, 95% CI -5.84 to -2.01; P = .003); physical symptom scores were reduced by -10.7 and -8.6 in active-treatment and placebo groups, respectively (adjusted mean difference -2.1, 95% CI -3.3 to -0.95; P < .001); and behavioral symptom scores were reduced by -7.7 and -6.2 in active-treatment and placebo groups, respectively (adjusted mean difference -1.5, 95% CI -2.251 to -0.727; P < .001). Response, defined as a 50% decrease in daily symptom scores, occurred in 48% of the active-treatment group and 36% of the placebo group (relative risk 1.7, 95% CI 1.1 to 2.6; P = .015) and corresponds to a number-needed-to-treat of 8 patients. Conclusion: A 24/4 regimen of drospirenone 3 mg and ethinyl estradiol 20 μg improves symptoms associated with premenstrual dysphoric disorder.

AB - Objective: To compare the efficacy of a new low-dose oral contraceptive pill (OCP) formulation with placebo in reducing symptoms of premenstrual dysphoric disorder. Methods: This multicenter, double-blind, randomized clinical trial consisted of 2 run-in and 3 treatment cycles with daily symptom charting; 450 women with symptoms of premenstrual dysphoric disorder were randomized to either placebo or an OCP formulation containing drospirenone 3 mg and ethinyl estradiol 20 μg. Hormones were administered for 24 days, followed by 4 days of inactive pills (24/4). Results: Scores on the total Daily Record of Severity of Problems decreased by -37.49 in the drospirenone/ethinyl estradiol group and by -29.99 in the placebo group (adjusted mean difference -7.5, 95% confidence interval [CI] -11.2 to -3.8; P < .001 by rank analysis of covariance). Mood symptom scores were reduced by -19.2 and -15.3 in active-treatment and placebo groups, respectively (adjusted mean difference -3.9, 95% CI -5.84 to -2.01; P = .003); physical symptom scores were reduced by -10.7 and -8.6 in active-treatment and placebo groups, respectively (adjusted mean difference -2.1, 95% CI -3.3 to -0.95; P < .001); and behavioral symptom scores were reduced by -7.7 and -6.2 in active-treatment and placebo groups, respectively (adjusted mean difference -1.5, 95% CI -2.251 to -0.727; P < .001). Response, defined as a 50% decrease in daily symptom scores, occurred in 48% of the active-treatment group and 36% of the placebo group (relative risk 1.7, 95% CI 1.1 to 2.6; P = .015) and corresponds to a number-needed-to-treat of 8 patients. Conclusion: A 24/4 regimen of drospirenone 3 mg and ethinyl estradiol 20 μg improves symptoms associated with premenstrual dysphoric disorder.

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