Effective Treatment of Heavy Menstrual Bleeding With Estradiol Valerate and Dienogest: A Randomized Controlled Trial
To estimate the efficacy of a fixed estrogen step-down and progestin step-up 28-day estradiol (E2) valerate and dienogest oral contraceptive regimen in women with heavy menstrual bleeding, prolonged menstrual bleeding, or heavy and prolonged menstrual bleeding without organic pathology. This double-...
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| Veröffentlicht in: | Obstetrics and gynecology (New York. 1953) 2011-04, Vol.117 (4), p.777-787 |
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| creator | Jensen, Jeffrey T. Parke, Susanne Mellinger, Uwe Machlitt, Andrea Fraser, Ian S. |
| description | To estimate the efficacy of a fixed estrogen step-down and progestin step-up 28-day estradiol (E2) valerate and dienogest oral contraceptive regimen in women with heavy menstrual bleeding, prolonged menstrual bleeding, or heavy and prolonged menstrual bleeding without organic pathology.
This double-blind, placebo-controlled study randomized women aged 18 years or older with prolonged, frequent, or heavy menstrual bleeding, objectively confirmed during a 90-day run-in phase, to treatment with E2 valerate and dienogest or placebo (2:1) for 196 days. Data from the last 90 days of treatment and the run-in phase were compared. The primary variable was the "complete response" rate (complete resolution of qualifying abnormal menstrual symptoms, including a 50% or greater reduction in pretreatment menstrual blood loss volume in women with heavy menstrual bleeding). Secondary variables included objective changes in menstrual blood loss volume (alkaline hematin methodology) and iron metabolism parameters. Overall, 180 women were needed to provide 90% power.
There were no marked differences in the characteristics of E2 valerate and dienogest (n=120) and placebo (n=70) recipients. The proportion of "complete responders" in the evaluable group was significantly higher in E2 valerate and dienogest (35/80; 43.8%) compared with placebo (2/48, 4.2%, P |
| doi_str_mv | 10.1097/AOG.0b013e3182118ac3 |
| format | Article |
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This double-blind, placebo-controlled study randomized women aged 18 years or older with prolonged, frequent, or heavy menstrual bleeding, objectively confirmed during a 90-day run-in phase, to treatment with E2 valerate and dienogest or placebo (2:1) for 196 days. Data from the last 90 days of treatment and the run-in phase were compared. The primary variable was the "complete response" rate (complete resolution of qualifying abnormal menstrual symptoms, including a 50% or greater reduction in pretreatment menstrual blood loss volume in women with heavy menstrual bleeding). Secondary variables included objective changes in menstrual blood loss volume (alkaline hematin methodology) and iron metabolism parameters. Overall, 180 women were needed to provide 90% power.
There were no marked differences in the characteristics of E2 valerate and dienogest (n=120) and placebo (n=70) recipients. The proportion of "complete responders" in the evaluable group was significantly higher in E2 valerate and dienogest (35/80; 43.8%) compared with placebo (2/48, 4.2%, P<.001) recipients. The mean [standard deviation] reduction in menstrual blood loss with E2 valerate and dienogest from the run-in phase to the efficacy phase was substantial (-353 mL [309 mL]; mean -64.2%; median -70.6%) and significantly greater than that in placebo recipients (-130 mL [338 mL]; mean -7.8%; median -18.7%; P<.001). Significant improvements in hemoglobin, hematocrit, and ferritin were seen with E2 valerate and dienogest, but not with placebo.
Oral E2 valerate and dienogest was highly effective compared with placebo in the treatment of women with heavy menstrual bleeding, prolonged menstrual bleeding, or heavy and prolonged menstrual bleeding without organic pathology.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00293059.
I.</description><identifier>ISSN: 0029-7844</identifier><identifier>EISSN: 1873-233X</identifier><identifier>DOI: 10.1097/AOG.0b013e3182118ac3</identifier><identifier>PMID: 21422847</identifier><identifier>CODEN: OBGNAS</identifier><language>eng</language><publisher>Hagerstown, MD: by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved</publisher><subject>Adult ; Biological and medical sciences ; Confidence Intervals ; Contraceptives, Oral - administration & dosage ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Drug Therapy, Combination ; Estradiol - administration & dosage ; Estradiol - analogs & derivatives ; Female ; Gynecology. Andrology. Obstetrics ; Humans ; Medical sciences ; Menorrhagia - diagnosis ; Menorrhagia - drug therapy ; Nandrolone - administration & dosage ; Nandrolone - analogs & derivatives ; Patient Satisfaction ; Quality of Life ; Reference Values ; Risk Assessment ; Severity of Illness Index ; Treatment Outcome</subject><ispartof>Obstetrics and gynecology (New York. 1953), 2011-04, Vol.117 (4), p.777-787</ispartof><rights>by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3563-a2eb27e205f1a3f059a099e60bc4880a900ff10f8b480b86b0214b095c672de73</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=24025071$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21422847$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jensen, Jeffrey T.</creatorcontrib><creatorcontrib>Parke, Susanne</creatorcontrib><creatorcontrib>Mellinger, Uwe</creatorcontrib><creatorcontrib>Machlitt, Andrea</creatorcontrib><creatorcontrib>Fraser, Ian S.</creatorcontrib><title>Effective Treatment of Heavy Menstrual Bleeding With Estradiol Valerate and Dienogest: A Randomized Controlled Trial</title><title>Obstetrics and gynecology (New York. 1953)</title><addtitle>Obstet Gynecol</addtitle><description>To estimate the efficacy of a fixed estrogen step-down and progestin step-up 28-day estradiol (E2) valerate and dienogest oral contraceptive regimen in women with heavy menstrual bleeding, prolonged menstrual bleeding, or heavy and prolonged menstrual bleeding without organic pathology.
This double-blind, placebo-controlled study randomized women aged 18 years or older with prolonged, frequent, or heavy menstrual bleeding, objectively confirmed during a 90-day run-in phase, to treatment with E2 valerate and dienogest or placebo (2:1) for 196 days. Data from the last 90 days of treatment and the run-in phase were compared. The primary variable was the "complete response" rate (complete resolution of qualifying abnormal menstrual symptoms, including a 50% or greater reduction in pretreatment menstrual blood loss volume in women with heavy menstrual bleeding). Secondary variables included objective changes in menstrual blood loss volume (alkaline hematin methodology) and iron metabolism parameters. Overall, 180 women were needed to provide 90% power.
There were no marked differences in the characteristics of E2 valerate and dienogest (n=120) and placebo (n=70) recipients. The proportion of "complete responders" in the evaluable group was significantly higher in E2 valerate and dienogest (35/80; 43.8%) compared with placebo (2/48, 4.2%, P<.001) recipients. The mean [standard deviation] reduction in menstrual blood loss with E2 valerate and dienogest from the run-in phase to the efficacy phase was substantial (-353 mL [309 mL]; mean -64.2%; median -70.6%) and significantly greater than that in placebo recipients (-130 mL [338 mL]; mean -7.8%; median -18.7%; P<.001). Significant improvements in hemoglobin, hematocrit, and ferritin were seen with E2 valerate and dienogest, but not with placebo.
Oral E2 valerate and dienogest was highly effective compared with placebo in the treatment of women with heavy menstrual bleeding, prolonged menstrual bleeding, or heavy and prolonged menstrual bleeding without organic pathology.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00293059.
I.</description><subject>Adult</subject><subject>Biological and medical sciences</subject><subject>Confidence Intervals</subject><subject>Contraceptives, Oral - administration & dosage</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Drug Therapy, Combination</subject><subject>Estradiol - administration & dosage</subject><subject>Estradiol - analogs & derivatives</subject><subject>Female</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Humans</subject><subject>Medical sciences</subject><subject>Menorrhagia - diagnosis</subject><subject>Menorrhagia - drug therapy</subject><subject>Nandrolone - administration & dosage</subject><subject>Nandrolone - analogs & derivatives</subject><subject>Patient Satisfaction</subject><subject>Quality of Life</subject><subject>Reference Values</subject><subject>Risk Assessment</subject><subject>Severity of Illness Index</subject><subject>Treatment Outcome</subject><issn>0029-7844</issn><issn>1873-233X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkVtP3DAQha2qqGwp_wAhv_QxML4kcfq2XbaARIVUbVveokkyZt16E2R7QfTXY8RN6pPHR9-Z0Zxh7EDAkYCmPp5fnh5BB0KREkYKYbBX79hMmFoVUqmr92wGIJuiNlrvso8x_gEAUTXqA9uVQktpdD1jaWkt9cndEl8FwrShMfHJ8jPC23v-ncaYwhY9_-qJBjde898urfkyqzi4yfNf6ClgIo7jwE8cjdM1xfSFz_mPrEwb948GvpjGFCbvc7kKDv0ntmPRR9p_fvfYz2_L1eKsuLg8PV_ML4pelZUqUFIna5JQWoHKQtkgNA1V0PXaGMAGwFoB1nTaQGeqDvJeHTRlX9VyoFrtMf3Utw9TjIFsexPcBsN9K6B9DLHNIbb_h5hth0-2m223oeHV9JJaBj4_Axh79Dbg2Lv4xmmQJdTibf7d5BOF-Ndv7yi0a0Kf1m0-B1QZLCQIATr_ikdJqQfbEIso</recordid><startdate>20110401</startdate><enddate>20110401</enddate><creator>Jensen, Jeffrey T.</creator><creator>Parke, Susanne</creator><creator>Mellinger, Uwe</creator><creator>Machlitt, Andrea</creator><creator>Fraser, Ian S.</creator><general>by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved</general><general>Lippincott Williams & Wilkins</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></search><sort><creationdate>20110401</creationdate><title>Effective Treatment of Heavy Menstrual Bleeding With Estradiol Valerate and Dienogest: A Randomized Controlled Trial</title><author>Jensen, Jeffrey T. ; Parke, Susanne ; Mellinger, Uwe ; Machlitt, Andrea ; Fraser, Ian S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3563-a2eb27e205f1a3f059a099e60bc4880a900ff10f8b480b86b0214b095c672de73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adult</topic><topic>Biological and medical sciences</topic><topic>Confidence Intervals</topic><topic>Contraceptives, Oral - administration & dosage</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Drug Therapy, Combination</topic><topic>Estradiol - administration & dosage</topic><topic>Estradiol - analogs & derivatives</topic><topic>Female</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Humans</topic><topic>Medical sciences</topic><topic>Menorrhagia - diagnosis</topic><topic>Menorrhagia - drug therapy</topic><topic>Nandrolone - administration & dosage</topic><topic>Nandrolone - analogs & derivatives</topic><topic>Patient Satisfaction</topic><topic>Quality of Life</topic><topic>Reference Values</topic><topic>Risk Assessment</topic><topic>Severity of Illness Index</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jensen, Jeffrey T.</creatorcontrib><creatorcontrib>Parke, Susanne</creatorcontrib><creatorcontrib>Mellinger, Uwe</creatorcontrib><creatorcontrib>Machlitt, Andrea</creatorcontrib><creatorcontrib>Fraser, Ian S.</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><jtitle>Obstetrics and gynecology (New York. 1953)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jensen, Jeffrey T.</au><au>Parke, Susanne</au><au>Mellinger, Uwe</au><au>Machlitt, Andrea</au><au>Fraser, Ian S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effective Treatment of Heavy Menstrual Bleeding With Estradiol Valerate and Dienogest: A Randomized Controlled Trial</atitle><jtitle>Obstetrics and gynecology (New York. 1953)</jtitle><addtitle>Obstet Gynecol</addtitle><date>2011-04-01</date><risdate>2011</risdate><volume>117</volume><issue>4</issue><spage>777</spage><epage>787</epage><pages>777-787</pages><issn>0029-7844</issn><eissn>1873-233X</eissn><coden>OBGNAS</coden><abstract>To estimate the efficacy of a fixed estrogen step-down and progestin step-up 28-day estradiol (E2) valerate and dienogest oral contraceptive regimen in women with heavy menstrual bleeding, prolonged menstrual bleeding, or heavy and prolonged menstrual bleeding without organic pathology.
This double-blind, placebo-controlled study randomized women aged 18 years or older with prolonged, frequent, or heavy menstrual bleeding, objectively confirmed during a 90-day run-in phase, to treatment with E2 valerate and dienogest or placebo (2:1) for 196 days. Data from the last 90 days of treatment and the run-in phase were compared. The primary variable was the "complete response" rate (complete resolution of qualifying abnormal menstrual symptoms, including a 50% or greater reduction in pretreatment menstrual blood loss volume in women with heavy menstrual bleeding). Secondary variables included objective changes in menstrual blood loss volume (alkaline hematin methodology) and iron metabolism parameters. Overall, 180 women were needed to provide 90% power.
There were no marked differences in the characteristics of E2 valerate and dienogest (n=120) and placebo (n=70) recipients. The proportion of "complete responders" in the evaluable group was significantly higher in E2 valerate and dienogest (35/80; 43.8%) compared with placebo (2/48, 4.2%, P<.001) recipients. The mean [standard deviation] reduction in menstrual blood loss with E2 valerate and dienogest from the run-in phase to the efficacy phase was substantial (-353 mL [309 mL]; mean -64.2%; median -70.6%) and significantly greater than that in placebo recipients (-130 mL [338 mL]; mean -7.8%; median -18.7%; P<.001). Significant improvements in hemoglobin, hematocrit, and ferritin were seen with E2 valerate and dienogest, but not with placebo.
Oral E2 valerate and dienogest was highly effective compared with placebo in the treatment of women with heavy menstrual bleeding, prolonged menstrual bleeding, or heavy and prolonged menstrual bleeding without organic pathology.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00293059.
I.</abstract><cop>Hagerstown, MD</cop><pub>by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved</pub><pmid>21422847</pmid><doi>10.1097/AOG.0b013e3182118ac3</doi><tpages>11</tpages></addata></record> |
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| ispartof | Obstetrics and gynecology (New York. 1953), 2011-04, Vol.117 (4), p.777-787 |
| issn | 0029-7844 1873-233X |
| language | eng |
| recordid | cdi_crossref_primary_10_1097_AOG_0b013e3182118ac3 |
| source | MEDLINE; Journals@Ovid Complete |
| subjects | Adult Biological and medical sciences Confidence Intervals Contraceptives, Oral - administration & dosage Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Drug Therapy, Combination Estradiol - administration & dosage Estradiol - analogs & derivatives Female Gynecology. Andrology. Obstetrics Humans Medical sciences Menorrhagia - diagnosis Menorrhagia - drug therapy Nandrolone - administration & dosage Nandrolone - analogs & derivatives Patient Satisfaction Quality of Life Reference Values Risk Assessment Severity of Illness Index Treatment Outcome |
| title | Effective Treatment of Heavy Menstrual Bleeding With Estradiol Valerate and Dienogest: A Randomized Controlled Trial |
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