Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder
To compare the efficacy of a new low-dose oral contraceptive pill (OCP) formulation with placebo in reducing symptoms of premenstrual dysphoric disorder. This multicenter, double-blind, randomized clinical trial consisted of 2 run-in and 3 treatment cycles with daily symptom charting; 450 women with...
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| Veröffentlicht in: | Obstetrics and gynecology (New York. 1953) 2005-09, Vol.106 (3), p.492-501 |
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| creator | YONKERS, Kimberly A BROWN, Candace PEARLSTEIN, Teri B FOEGH, Marie SAMPSON-LANDERS, Carole RAPKIN, Andrea |
| description | To compare the efficacy of a new low-dose oral contraceptive pill (OCP) formulation with placebo in reducing symptoms of premenstrual dysphoric disorder.
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).
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.
A 24/4 regimen of drospirenone 3 mg and ethinyl estradiol 20 mug improves symptoms associated with premenstrual dysphoric disorder.
I. |
| doi_str_mv | 10.1097/01.AOG.0000175834.77215.2e |
| format | Article |
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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).
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.
A 24/4 regimen of drospirenone 3 mg and ethinyl estradiol 20 mug improves symptoms associated with premenstrual dysphoric disorder.
I.</description><identifier>ISSN: 0029-7844</identifier><identifier>EISSN: 1873-233X</identifier><identifier>DOI: 10.1097/01.AOG.0000175834.77215.2e</identifier><identifier>PMID: 16135578</identifier><identifier>CODEN: OBGNAS</identifier><language>eng</language><publisher>New York, NY: Elsevier Science</publisher><subject><![CDATA[Adult ; Androstenes - administration & dosage ; Biological and medical sciences ; Contraceptives, Oral, Combined - administration & dosage ; Contraceptives, Oral, Hormonal - administration & dosage ; Double-Blind Method ; Estrogens - administration & dosage ; Ethinyl Estradiol - administration & dosage ; Female ; Female genital diseases ; Genital system. Reproduction ; Gynecology. Andrology. Obstetrics ; Humans ; Medical sciences ; Non tumoral diseases ; Pharmacology. Drug treatments ; Premenstrual Syndrome - drug therapy ; Progesterone Congeners - administration & dosage ; Quality of Life ; Treatment Outcome ; Uterine Hemorrhage - epidemiology]]></subject><ispartof>Obstetrics and gynecology (New York. 1953), 2005-09, Vol.106 (3), p.492-501</ispartof><rights>2005 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c424t-6ce8fc24110c062b07d09b5289810ea18f657991e9efb3a10aff2653a33ffe4b3</citedby><cites>FETCH-LOGICAL-c424t-6ce8fc24110c062b07d09b5289810ea18f657991e9efb3a10aff2653a33ffe4b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17065884$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16135578$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>YONKERS, Kimberly A</creatorcontrib><creatorcontrib>BROWN, Candace</creatorcontrib><creatorcontrib>PEARLSTEIN, Teri B</creatorcontrib><creatorcontrib>FOEGH, Marie</creatorcontrib><creatorcontrib>SAMPSON-LANDERS, Carole</creatorcontrib><creatorcontrib>RAPKIN, Andrea</creatorcontrib><title>Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder</title><title>Obstetrics and gynecology (New York. 1953)</title><addtitle>Obstet Gynecol</addtitle><description>To compare the efficacy of a new low-dose oral contraceptive pill (OCP) formulation with placebo in reducing symptoms of premenstrual dysphoric disorder.
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).
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.
A 24/4 regimen of drospirenone 3 mg and ethinyl estradiol 20 mug improves symptoms associated with premenstrual dysphoric disorder.
I.</description><subject>Adult</subject><subject>Androstenes - administration & dosage</subject><subject>Biological and medical sciences</subject><subject>Contraceptives, Oral, Combined - administration & dosage</subject><subject>Contraceptives, Oral, Hormonal - administration & dosage</subject><subject>Double-Blind Method</subject><subject>Estrogens - administration & dosage</subject><subject>Ethinyl Estradiol - administration & dosage</subject><subject>Female</subject><subject>Female genital diseases</subject><subject>Genital system. Reproduction</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Humans</subject><subject>Medical sciences</subject><subject>Non tumoral diseases</subject><subject>Pharmacology. Drug treatments</subject><subject>Premenstrual Syndrome - drug therapy</subject><subject>Progesterone Congeners - administration & dosage</subject><subject>Quality of Life</subject><subject>Treatment Outcome</subject><subject>Uterine Hemorrhage - epidemiology</subject><issn>0029-7844</issn><issn>1873-233X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkE1r3DAQhkVpaTZp_0IQheZmR6MPS84tLGkSCOTSQG5ClkdEwWu5kjfL_vs4zcLOZS7P-w7zEPILWA2s1ZcM6uvH25otA1oZIWutOaia4xeyAqNFxYV4_kpWjPG20kbKE3JayusH37TiOzmBBoRS2qxIdxNC9M7vaQrU0RF3dEi7qk8FacpuoD6Nc3Yepzm-Id3F-YX2OZUpZhzTiDSOdMq4wbHMebvw_b5MLylHT_tYUu4x_yDfghsK_jzsM_L05-bv-q56eLy9X18_VF5yOVeNRxM8lwDMs4Z3TPes7RQ3rQGGDkxolG5bwBZDJxwwFwJvlHBChICyE2fk4rN3yunfFstsN7F4HAY3YtoW2xilwEi9gFefoF8eKRmDnXLcuLy3wOyHYcvALobt0bD9b9hyXMLnhyvbboP9MXpQugC_D4Ar3g0hu9HHcuQ0a5QxUrwDAyGGaQ</recordid><startdate>20050901</startdate><enddate>20050901</enddate><creator>YONKERS, Kimberly A</creator><creator>BROWN, Candace</creator><creator>PEARLSTEIN, Teri B</creator><creator>FOEGH, Marie</creator><creator>SAMPSON-LANDERS, Carole</creator><creator>RAPKIN, Andrea</creator><general>Elsevier Science</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20050901</creationdate><title>Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder</title><author>YONKERS, Kimberly A ; BROWN, Candace ; PEARLSTEIN, Teri B ; FOEGH, Marie ; SAMPSON-LANDERS, Carole ; RAPKIN, Andrea</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c424t-6ce8fc24110c062b07d09b5289810ea18f657991e9efb3a10aff2653a33ffe4b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adult</topic><topic>Androstenes - administration & dosage</topic><topic>Biological and medical sciences</topic><topic>Contraceptives, Oral, Combined - administration & dosage</topic><topic>Contraceptives, Oral, Hormonal - administration & dosage</topic><topic>Double-Blind Method</topic><topic>Estrogens - administration & dosage</topic><topic>Ethinyl Estradiol - administration & dosage</topic><topic>Female</topic><topic>Female genital diseases</topic><topic>Genital system. Reproduction</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Humans</topic><topic>Medical sciences</topic><topic>Non tumoral diseases</topic><topic>Pharmacology. Drug treatments</topic><topic>Premenstrual Syndrome - drug therapy</topic><topic>Progesterone Congeners - administration & dosage</topic><topic>Quality of Life</topic><topic>Treatment Outcome</topic><topic>Uterine Hemorrhage - epidemiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>YONKERS, Kimberly A</creatorcontrib><creatorcontrib>BROWN, Candace</creatorcontrib><creatorcontrib>PEARLSTEIN, Teri B</creatorcontrib><creatorcontrib>FOEGH, Marie</creatorcontrib><creatorcontrib>SAMPSON-LANDERS, Carole</creatorcontrib><creatorcontrib>RAPKIN, Andrea</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Obstetrics and gynecology (New York. 1953)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>YONKERS, Kimberly A</au><au>BROWN, Candace</au><au>PEARLSTEIN, Teri B</au><au>FOEGH, Marie</au><au>SAMPSON-LANDERS, Carole</au><au>RAPKIN, Andrea</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder</atitle><jtitle>Obstetrics and gynecology (New York. 1953)</jtitle><addtitle>Obstet Gynecol</addtitle><date>2005-09-01</date><risdate>2005</risdate><volume>106</volume><issue>3</issue><spage>492</spage><epage>501</epage><pages>492-501</pages><issn>0029-7844</issn><eissn>1873-233X</eissn><coden>OBGNAS</coden><abstract>To compare the efficacy of a new low-dose oral contraceptive pill (OCP) formulation with placebo in reducing symptoms of premenstrual dysphoric disorder.
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).
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.
A 24/4 regimen of drospirenone 3 mg and ethinyl estradiol 20 mug improves symptoms associated with premenstrual dysphoric disorder.
I.</abstract><cop>New York, NY</cop><pub>Elsevier Science</pub><pmid>16135578</pmid><doi>10.1097/01.AOG.0000175834.77215.2e</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Obstetrics and gynecology (New York. 1953), 2005-09, Vol.106 (3), p.492-501 |
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| source | MEDLINE; Journals@Ovid Complete |
| subjects | Adult Androstenes - administration & dosage Biological and medical sciences Contraceptives, Oral, Combined - administration & dosage Contraceptives, Oral, Hormonal - administration & dosage Double-Blind Method Estrogens - administration & dosage Ethinyl Estradiol - administration & dosage Female Female genital diseases Genital system. Reproduction Gynecology. Andrology. Obstetrics Humans Medical sciences Non tumoral diseases Pharmacology. Drug treatments Premenstrual Syndrome - drug therapy Progesterone Congeners - administration & dosage Quality of Life Treatment Outcome Uterine Hemorrhage - epidemiology |
| title | Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder |
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