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Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder.
Obstet Gynecol. 2005 Sep; 106(3):492-501.OG

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 microg. 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 mug improves symptoms associated with premenstrual dysphoric disorder.

LEVEL OF EVIDENCE

I.

Authors+Show Affiliations

Department of Psychiatry, Yale University, New Haven, Connecticut 06510, USA. kimberly.yonkers@yale.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16135578

Citation

Yonkers, Kimberly A., et al. "Efficacy of a New Low-dose Oral Contraceptive With Drospirenone in Premenstrual Dysphoric Disorder." Obstetrics and Gynecology, vol. 106, no. 3, 2005, pp. 492-501.
Yonkers KA, Brown C, Pearlstein TB, et al. Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder. Obstet Gynecol. 2005;106(3):492-501.
Yonkers, K. A., Brown, C., Pearlstein, T. B., Foegh, M., Sampson-Landers, C., & Rapkin, A. (2005). Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder. Obstetrics and Gynecology, 106(3), 492-501.
Yonkers KA, et al. Efficacy of a New Low-dose Oral Contraceptive With Drospirenone in Premenstrual Dysphoric Disorder. Obstet Gynecol. 2005;106(3):492-501. PubMed PMID: 16135578.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder. AU - Yonkers,Kimberly A, AU - Brown,Candace, AU - Pearlstein,Teri B, AU - Foegh,Marie, AU - Sampson-Landers,Carole, AU - Rapkin,Andrea, PY - 2005/9/2/pubmed PY - 2005/11/9/medline PY - 2005/9/2/entrez SP - 492 EP - 501 JF - Obstetrics and gynecology JO - Obstet Gynecol VL - 106 IS - 3 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 microg. 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 mug improves symptoms associated with premenstrual dysphoric disorder. LEVEL OF EVIDENCE: I. SN - 0029-7844 UR - https://www.unboundmedicine.com/medline/citation/16135578/Efficacy_of_a_new_low_dose_oral_contraceptive_with_drospirenone_in_premenstrual_dysphoric_disorder_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&amp;PAGE=linkout&amp;SEARCH=16135578.ui DB - PRIME DP - Unbound Medicine ER -