Serveur d'exploration sur l'Université de Trèves

Attention, ce site est en cours de développement !
Attention, site généré par des moyens informatiques à partir de corpus bruts.
Les informations ne sont donc pas validées.

A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel over six treatment cycles

Identifieur interne : 001049 ( Istex/Corpus ); précédent : 001048; suivant : 001050

A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel over six treatment cycles

Auteurs : R. Bannemerschult ; J. P. Hanker ; C. Wünsch ; P. Fox ; M. Albring ; K. Brill

Source :

RBID : ISTEX:703BB529C9960DFFF15F67B3AD6A580DF371FBDB

Abstract

The aim of the trial was to demonstrate the contraceptive efficacy of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel and to observe cycle control and safety. Data from 805 treated women resulted in 4400 treatment cycles. One pregnancy occurred while on the trial medication as a result of method failure, resulting in a Pearl index of 0.29. Cycle control was good, and cycle length as well as duration and intensity of withdrawal bleeding were not significantly changed during the trial. Intermenstrual bleeding usually occurred as spotting and decreased considerably during the treatment phase. Spotting alone was reported in 12.4% of cycles, breakthrough bleeding alone in 4.5% of cycles, and breakthrough bleeding and spotting together in 1.4% of treatment cycles. The rate of absence of withdrawal bleeding declined throughout the trial to 2.4% in cycle 6. There were no serious adverse events related to treatment, and most adverse events were those commonly observed in clinical trials with oral contraceptives. Headache, breast tension, and nausea were reported by 17.3%, 11.0%, and 7.7% of the women, respectively. There were no clinically relevant changes in laboratory parameters, blood pressure, or weight. In this trial, the new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel was shown to be effective, safe, and well tolerated. Cycle control was found to be good and there was a low incidence of adverse events.

Url:
DOI: 10.1016/S0010-7824(97)00157-1

Links to Exploration step

ISTEX:703BB529C9960DFFF15F67B3AD6A580DF371FBDB

Le document en format XML

<record>
<TEI wicri:istexFullTextTei="biblStruct">
<teiHeader>
<fileDesc>
<titleStmt>
<title>A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel over six treatment cycles</title>
<author>
<name sortKey="Bannemerschult, R" sort="Bannemerschult, R" uniqKey="Bannemerschult R" first="R." last="Bannemerschult">R. Bannemerschult</name>
<affiliation>
<mods:affiliation>Schering AG, German Operations, Berlin, Germany</mods:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Hanker, J P" sort="Hanker, J P" uniqKey="Hanker J" first="J. P." last="Hanker">J. P. Hanker</name>
<affiliation>
<mods:affiliation>Department of Obstetrics, Krankenanstalten der Mutter der Borromaerinnen, Trier, Germany.</mods:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Wunsch, C" sort="Wunsch, C" uniqKey="Wunsch C" first="C." last="Wünsch">C. Wünsch</name>
<affiliation>
<mods:affiliation>Schering AG, German Operations, Berlin, Germany</mods:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Fox, P" sort="Fox, P" uniqKey="Fox P" first="P." last="Fox">P. Fox</name>
<affiliation>
<mods:affiliation>Schering AG, German Operations, Berlin, Germany</mods:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Albring, M" sort="Albring, M" uniqKey="Albring M" first="M." last="Albring">M. Albring</name>
<affiliation>
<mods:affiliation>Schering AG, German Operations, Berlin, Germany</mods:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Brill, K" sort="Brill, K" uniqKey="Brill K" first="K." last="Brill">K. Brill</name>
<affiliation>
<mods:affiliation>Schering AG, German Operations, Berlin, Germany</mods:affiliation>
</affiliation>
</author>
</titleStmt>
<publicationStmt>
<idno type="wicri:source">ISTEX</idno>
<idno type="RBID">ISTEX:703BB529C9960DFFF15F67B3AD6A580DF371FBDB</idno>
<date when="1997" year="1997">1997</date>
<idno type="doi">10.1016/S0010-7824(97)00157-1</idno>
<idno type="url">https://api.istex.fr/document/703BB529C9960DFFF15F67B3AD6A580DF371FBDB/fulltext/pdf</idno>
<idno type="wicri:Area/Istex/Corpus">001049</idno>
<idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001049</idno>
</publicationStmt>
<sourceDesc>
<biblStruct>
<analytic>
<title level="a">A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel over six treatment cycles</title>
<author>
<name sortKey="Bannemerschult, R" sort="Bannemerschult, R" uniqKey="Bannemerschult R" first="R." last="Bannemerschult">R. Bannemerschult</name>
<affiliation>
<mods:affiliation>Schering AG, German Operations, Berlin, Germany</mods:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Hanker, J P" sort="Hanker, J P" uniqKey="Hanker J" first="J. P." last="Hanker">J. P. Hanker</name>
<affiliation>
<mods:affiliation>Department of Obstetrics, Krankenanstalten der Mutter der Borromaerinnen, Trier, Germany.</mods:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Wunsch, C" sort="Wunsch, C" uniqKey="Wunsch C" first="C." last="Wünsch">C. Wünsch</name>
<affiliation>
<mods:affiliation>Schering AG, German Operations, Berlin, Germany</mods:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Fox, P" sort="Fox, P" uniqKey="Fox P" first="P." last="Fox">P. Fox</name>
<affiliation>
<mods:affiliation>Schering AG, German Operations, Berlin, Germany</mods:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Albring, M" sort="Albring, M" uniqKey="Albring M" first="M." last="Albring">M. Albring</name>
<affiliation>
<mods:affiliation>Schering AG, German Operations, Berlin, Germany</mods:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Brill, K" sort="Brill, K" uniqKey="Brill K" first="K." last="Brill">K. Brill</name>
<affiliation>
<mods:affiliation>Schering AG, German Operations, Berlin, Germany</mods:affiliation>
</affiliation>
</author>
</analytic>
<monogr></monogr>
<series>
<title level="j">Contraception</title>
<title level="j" type="abbrev">CON</title>
<idno type="ISSN">0010-7824</idno>
<imprint>
<publisher>ELSEVIER</publisher>
<date type="published" when="1997">1997</date>
<biblScope unit="volume">56</biblScope>
<biblScope unit="issue">5</biblScope>
<biblScope unit="page" from="285">285</biblScope>
<biblScope unit="page" to="290">290</biblScope>
</imprint>
<idno type="ISSN">0010-7824</idno>
</series>
<idno type="istex">703BB529C9960DFFF15F67B3AD6A580DF371FBDB</idno>
<idno type="DOI">10.1016/S0010-7824(97)00157-1</idno>
<idno type="PII">S0010-7824(97)00157-1</idno>
</biblStruct>
</sourceDesc>
<seriesStmt>
<idno type="ISSN">0010-7824</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass></textClass>
<langUsage>
<language ident="en">en</language>
</langUsage>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">The aim of the trial was to demonstrate the contraceptive efficacy of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel and to observe cycle control and safety. Data from 805 treated women resulted in 4400 treatment cycles. One pregnancy occurred while on the trial medication as a result of method failure, resulting in a Pearl index of 0.29. Cycle control was good, and cycle length as well as duration and intensity of withdrawal bleeding were not significantly changed during the trial. Intermenstrual bleeding usually occurred as spotting and decreased considerably during the treatment phase. Spotting alone was reported in 12.4% of cycles, breakthrough bleeding alone in 4.5% of cycles, and breakthrough bleeding and spotting together in 1.4% of treatment cycles. The rate of absence of withdrawal bleeding declined throughout the trial to 2.4% in cycle 6. There were no serious adverse events related to treatment, and most adverse events were those commonly observed in clinical trials with oral contraceptives. Headache, breast tension, and nausea were reported by 17.3%, 11.0%, and 7.7% of the women, respectively. There were no clinically relevant changes in laboratory parameters, blood pressure, or weight. In this trial, the new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel was shown to be effective, safe, and well tolerated. Cycle control was found to be good and there was a low incidence of adverse events.</div>
</front>
</TEI>
<istex>
<corpusName>elsevier</corpusName>
<author>
<json:item>
<name>R. Bannemerschult</name>
<affiliations>
<json:string>Schering AG, German Operations, Berlin, Germany</json:string>
</affiliations>
</json:item>
<json:item>
<name>J.P. Hanker</name>
<affiliations>
<json:string>Department of Obstetrics, Krankenanstalten der Mutter der Borromaerinnen, Trier, Germany.</json:string>
</affiliations>
</json:item>
<json:item>
<name>C. Wünsch</name>
<affiliations>
<json:string>Schering AG, German Operations, Berlin, Germany</json:string>
</affiliations>
</json:item>
<json:item>
<name>P. Fox</name>
<affiliations>
<json:string>Schering AG, German Operations, Berlin, Germany</json:string>
</affiliations>
</json:item>
<json:item>
<name>M. Albring</name>
<affiliations>
<json:string>Schering AG, German Operations, Berlin, Germany</json:string>
</affiliations>
</json:item>
<json:item>
<name>K. Brill</name>
<affiliations>
<json:string>Schering AG, German Operations, Berlin, Germany</json:string>
</affiliations>
</json:item>
</author>
<subject>
<json:item>
<lang>
<json:string>eng</json:string>
</lang>
<value>low dose oral contraceptive</value>
</json:item>
<json:item>
<lang>
<json:string>eng</json:string>
</lang>
<value>efficacy</value>
</json:item>
<json:item>
<lang>
<json:string>eng</json:string>
</lang>
<value>cycle control</value>
</json:item>
<json:item>
<lang>
<json:string>eng</json:string>
</lang>
<value>side effects</value>
</json:item>
</subject>
<language>
<json:string>eng</json:string>
</language>
<originalGenre>
<json:string>Full-length article</json:string>
</originalGenre>
<abstract>The aim of the trial was to demonstrate the contraceptive efficacy of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel and to observe cycle control and safety. Data from 805 treated women resulted in 4400 treatment cycles. One pregnancy occurred while on the trial medication as a result of method failure, resulting in a Pearl index of 0.29. Cycle control was good, and cycle length as well as duration and intensity of withdrawal bleeding were not significantly changed during the trial. Intermenstrual bleeding usually occurred as spotting and decreased considerably during the treatment phase. Spotting alone was reported in 12.4% of cycles, breakthrough bleeding alone in 4.5% of cycles, and breakthrough bleeding and spotting together in 1.4% of treatment cycles. The rate of absence of withdrawal bleeding declined throughout the trial to 2.4% in cycle 6. There were no serious adverse events related to treatment, and most adverse events were those commonly observed in clinical trials with oral contraceptives. Headache, breast tension, and nausea were reported by 17.3%, 11.0%, and 7.7% of the women, respectively. There were no clinically relevant changes in laboratory parameters, blood pressure, or weight. In this trial, the new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel was shown to be effective, safe, and well tolerated. Cycle control was found to be good and there was a low incidence of adverse events.</abstract>
<qualityIndicators>
<score>5.813</score>
<pdfVersion>1.3</pdfVersion>
<pdfPageSize>583 x 790 pts</pdfPageSize>
<refBibsNative>true</refBibsNative>
<keywordCount>4</keywordCount>
<abstractCharCount>1514</abstractCharCount>
<pdfWordCount>2957</pdfWordCount>
<pdfCharCount>21351</pdfCharCount>
<pdfPageCount>6</pdfPageCount>
<abstractWordCount>238</abstractWordCount>
</qualityIndicators>
<title>A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel over six treatment cycles</title>
<pii>
<json:string>S0010-7824(97)00157-1</json:string>
</pii>
<refBibs>
<json:item>
<author>
<json:item>
<name>WHW Inman</name>
</json:item>
<json:item>
<name>MP Vessey</name>
</json:item>
<json:item>
<name>B Westerholm</name>
</json:item>
<json:item>
<name>A Engelund</name>
</json:item>
</author>
<host>
<volume>2</volume>
<pages>
<last>209</last>
<first>203</first>
</pages>
<author></author>
<title>Br Med J</title>
</host>
<title>Thromboembolic disease and the steroidal content of oral contraceptives: a report to the Committee on Safety of Drugs</title>
</json:item>
<json:item>
<author>
<json:item>
<name>BB Gerstman</name>
</json:item>
<json:item>
<name>JM Piper</name>
</json:item>
<json:item>
<name>JP Freiman</name>
</json:item>
</author>
<host>
<volume>102</volume>
<pages>
<last>208</last>
<first>197</first>
</pages>
<author></author>
<title>Int J Epidemiol</title>
</host>
<title>Oral contraceptive oestrogen and progestin potencies and the incidence of deep venous thromboembolism</title>
</json:item>
<json:item>
<author>
<json:item>
<name>MP Vessey</name>
</json:item>
</author>
<host>
<volume>34</volume>
<pages>
<last>70</last>
<first>64</first>
</pages>
<author></author>
<title>Int J Fertil</title>
</host>
<title>Epidemiologic studies of oral contraceptives</title>
</json:item>
<json:item>
<author>
<json:item>
<name>JR Newton</name>
</json:item>
<json:item>
<name>C d'Arcangues</name>
</json:item>
<json:item>
<name>PE Hall</name>
</json:item>
</author>
<host>
<volume>14</volume>
<pages>
<last>34</last>
<first>1</first>
</pages>
<author></author>
<title>Obstet Gynecol</title>
</host>
<title>A review of “once a month” combined injectable contraceptives</title>
</json:item>
<json:item>
<author>
<json:item>
<name>B Düsterberg</name>
</json:item>
<json:item>
<name>S Beier</name>
</json:item>
<json:item>
<name>WHF Schneider</name>
</json:item>
<json:item>
<name>J Spona</name>
</json:item>
</author>
<host>
<pages>
<last>29</last>
<first>13</first>
</pages>
<author></author>
<title>Gestodene a new direction in oral contraception</title>
</host>
<title>Pharmacological features of gestodene in laboratory animals and man</title>
</json:item>
<json:item>
<author>
<json:item>
<name>J Spona</name>
</json:item>
<json:item>
<name>W Feichtinger</name>
</json:item>
<json:item>
<name>C Kindermann</name>
</json:item>
<json:item>
<name>C Wünsch</name>
</json:item>
<json:item>
<name>K Brill</name>
</json:item>
</author>
<host>
<volume>54</volume>
<pages>
<last>304</last>
<first>299</first>
</pages>
<author></author>
<title>Contraception</title>
</host>
<title>Inhibition of ovulation by an oral contraceptive containing 100 μg levonorgestrel in combination with 20 μg ethinyl estradiol</title>
</json:item>
<json:item>
<author>
<json:item>
<name>JN Sartoretto</name>
</json:item>
<json:item>
<name>JC Ortega</name>
</json:item>
</author>
<host>
<volume>3</volume>
<pages>
<last>404</last>
<first>399</first>
</pages>
<author></author>
<title>Rev Bras Clin Therap</title>
</host>
<title>Clinical evaluation of a low dose oestrogen/progestogen combination (100 μg of d-norgestrel and 20 μg of ethinylestradiol)</title>
</json:item>
<json:item>
<author>
<json:item>
<name>MP Vessey</name>
</json:item>
</author>
<host>
<volume>i</volume>
<pages>
<last>842</last>
<first>841</first>
</pages>
<author></author>
<title>Lancet</title>
</host>
<title>Efficacy of different contraceptive methods</title>
</json:item>
<json:item>
<author>
<json:item>
<name>L Speroff</name>
</json:item>
<json:item>
<name>A De Cherney</name>
</json:item>
</author>
<host>
<volume>81</volume>
<pages>
<last>1047</last>
<first>1034</first>
</pages>
<author></author>
<title>Obstet Gynecol</title>
</host>
<title>Evaluation of a new generation of oral contraceptives</title>
</json:item>
<json:item>
<author>
<json:item>
<name>SL Corson</name>
</json:item>
</author>
<host>
<volume>170</volume>
<pages>
<last>1561</last>
<first>1556</first>
</pages>
<author></author>
<title>Am J Obstet Gynecol</title>
</host>
<title>Efficacy and safety of a monophasic and a triphasic oral contraceptive containing norgestimate</title>
</json:item>
<json:item>
<author>
<json:item>
<name>J Endrikat</name>
</json:item>
<json:item>
<name>MA Jaques</name>
</json:item>
<json:item>
<name>M Mayerhofer</name>
</json:item>
<json:item>
<name>C Pelissier</name>
</json:item>
<json:item>
<name>U Müller</name>
</json:item>
<json:item>
<name>B Düsterberg</name>
</json:item>
</author>
<host>
<volume>52</volume>
<pages>
<last>235</last>
<first>229</first>
</pages>
<author></author>
<title>Contraception</title>
</host>
<title>A twelve-month comparative clinical investigation of two low-dose oral contraceptives containing 20 μg ethinyl estradiol/75 μg gestodene and 20 μg ethinyl estradiol/150 μg desogestrel with respect to efficacy, cycle control and tolerance</title>
</json:item>
<json:item>
<author>
<json:item>
<name>M Akerlund</name>
</json:item>
<json:item>
<name>A Rode</name>
</json:item>
<json:item>
<name>J Westergaard</name>
</json:item>
</author>
<host>
<volume>100</volume>
<pages>
<last>838</last>
<first>832</first>
</pages>
<author></author>
<title>Br J Obstet Gynaecol</title>
</host>
<title>Comparative profiles of reliability, cycle control and side effects of two oral contraceptive formulations containing 150 μg desogestrel and either 30 μg or 20 μg ethinyl oestradiol</title>
</json:item>
<json:item>
<author>
<json:item>
<name>MJ Rosenberg</name>
</json:item>
<json:item>
<name>SC Long</name>
</json:item>
</author>
<host>
<volume>8</volume>
<pages>
<last>45</last>
<first>35</first>
</pages>
<author></author>
<title>Adv Contraception</title>
</host>
<title>Oral contraceptives and cycle control: a critical review of the literature</title>
</json:item>
<json:item>
<author>
<json:item>
<name>B Düsterberg</name>
</json:item>
<json:item>
<name>H Ellman</name>
</json:item>
<json:item>
<name>U Müller</name>
</json:item>
<json:item>
<name>E Rowe</name>
</json:item>
<json:item>
<name>B Mühe</name>
</json:item>
</author>
<host>
<volume>10</volume>
<pages>
<last>39</last>
<first>33</first>
</pages>
<author></author>
<title>Gynecol Endocrinol</title>
</host>
<title>A three-year clinical investigation into efficacy, cycle control and tolerability of a new low-dose monophasic oral contraceptive containing gestodene</title>
</json:item>
<json:item>
<author>
<json:item>
<name>RJE Kirkman</name>
</json:item>
<json:item>
<name>JH Pedersen</name>
</json:item>
<json:item>
<name>P Fioretti</name>
</json:item>
<json:item>
<name>HE Roberts</name>
</json:item>
</author>
<host>
<volume>49</volume>
<pages>
<last>46</last>
<first>33</first>
</pages>
<author></author>
<title>Contraception</title>
</host>
<title>Clinical comparison of two low-dose oral contraceptives, Minulet® and Mercilon®, in women over 30 years of age</title>
</json:item>
<json:item>
<author>
<json:item>
<name>DF Archer</name>
</json:item>
<json:item>
<name>R Maheux</name>
</json:item>
<json:item>
<name>A DelConte</name>
</json:item>
<json:item>
<name>FB O'Brien</name>
</json:item>
</author>
<host>
<volume>55</volume>
<pages>
<last>144</last>
<first>139</first>
</pages>
<author></author>
<title>Contraception</title>
</host>
<title>A new low-dose monophasic combination oral contraceptive (Alesse®) with levonorgestrel 100 μg and ethinyl estradiol 20 μg</title>
</json:item>
</refBibs>
<genre>
<json:string>research-article</json:string>
</genre>
<host>
<volume>56</volume>
<pii>
<json:string>S0010-7824(00)X0034-0</json:string>
</pii>
<pages>
<last>290</last>
<first>285</first>
</pages>
<issn>
<json:string>0010-7824</json:string>
</issn>
<issue>5</issue>
<genre>
<json:string>journal</json:string>
</genre>
<language>
<json:string>unknown</json:string>
</language>
<title>Contraception</title>
<publicationDate>1997</publicationDate>
</host>
<categories>
<wos>
<json:string>science</json:string>
<json:string>obstetrics & gynecology</json:string>
</wos>
<scienceMetrix>
<json:string>health sciences</json:string>
<json:string>clinical medicine</json:string>
<json:string>obstetrics & reproductive medicine</json:string>
</scienceMetrix>
</categories>
<publicationDate>1997</publicationDate>
<copyrightDate>1997</copyrightDate>
<doi>
<json:string>10.1016/S0010-7824(97)00157-1</json:string>
</doi>
<id>703BB529C9960DFFF15F67B3AD6A580DF371FBDB</id>
<score>0.34606665</score>
<fulltext>
<json:item>
<extension>pdf</extension>
<original>true</original>
<mimetype>application/pdf</mimetype>
<uri>https://api.istex.fr/document/703BB529C9960DFFF15F67B3AD6A580DF371FBDB/fulltext/pdf</uri>
</json:item>
<json:item>
<extension>zip</extension>
<original>false</original>
<mimetype>application/zip</mimetype>
<uri>https://api.istex.fr/document/703BB529C9960DFFF15F67B3AD6A580DF371FBDB/fulltext/zip</uri>
</json:item>
<istex:fulltextTEI uri="https://api.istex.fr/document/703BB529C9960DFFF15F67B3AD6A580DF371FBDB/fulltext/tei">
<teiHeader>
<fileDesc>
<titleStmt>
<title level="a">A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel over six treatment cycles</title>
</titleStmt>
<publicationStmt>
<authority>ISTEX</authority>
<publisher>ELSEVIER</publisher>
<availability>
<p>ELSEVIER</p>
</availability>
<date>1997</date>
</publicationStmt>
<notesStmt>
<note type="content">Section title: Original research article</note>
</notesStmt>
<sourceDesc>
<biblStruct type="inbook">
<analytic>
<title level="a">A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel over six treatment cycles</title>
<author xml:id="author-1">
<persName>
<forename type="first">R.</forename>
<surname>Bannemerschult</surname>
</persName>
<affiliation>Name and address for correspondence: Dr. Ralf Bannemerschult, Schering AG. Geschäftsbereich Deutschland, Max-Dohrn-Straße 10, 13342 Berlin, Germany; Tel.: +49-30-3498-9105; Fax: +49-30-3498-9291</affiliation>
<affiliation>Schering AG, German Operations, Berlin, Germany</affiliation>
</author>
<author xml:id="author-2">
<persName>
<forename type="first">J.P.</forename>
<surname>Hanker</surname>
</persName>
<affiliation>Department of Obstetrics, Krankenanstalten der Mutter der Borromaerinnen, Trier, Germany.</affiliation>
</author>
<author xml:id="author-3">
<persName>
<forename type="first">C.</forename>
<surname>Wünsch</surname>
</persName>
<affiliation>Schering AG, German Operations, Berlin, Germany</affiliation>
</author>
<author xml:id="author-4">
<persName>
<forename type="first">P.</forename>
<surname>Fox</surname>
</persName>
<affiliation>Schering AG, German Operations, Berlin, Germany</affiliation>
</author>
<author xml:id="author-5">
<persName>
<forename type="first">M.</forename>
<surname>Albring</surname>
</persName>
<affiliation>Schering AG, German Operations, Berlin, Germany</affiliation>
</author>
<author xml:id="author-6">
<persName>
<forename type="first">K.</forename>
<surname>Brill</surname>
</persName>
<affiliation>Schering AG, German Operations, Berlin, Germany</affiliation>
</author>
</analytic>
<monogr>
<title level="j">Contraception</title>
<title level="j" type="abbrev">CON</title>
<idno type="pISSN">0010-7824</idno>
<idno type="PII">S0010-7824(00)X0034-0</idno>
<imprint>
<publisher>ELSEVIER</publisher>
<date type="published" when="1997"></date>
<biblScope unit="volume">56</biblScope>
<biblScope unit="issue">5</biblScope>
<biblScope unit="page" from="285">285</biblScope>
<biblScope unit="page" to="290">290</biblScope>
</imprint>
</monogr>
<idno type="istex">703BB529C9960DFFF15F67B3AD6A580DF371FBDB</idno>
<idno type="DOI">10.1016/S0010-7824(97)00157-1</idno>
<idno type="PII">S0010-7824(97)00157-1</idno>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc>
<creation>
<date>1997</date>
</creation>
<langUsage>
<language ident="en">en</language>
</langUsage>
<abstract xml:lang="en">
<p>The aim of the trial was to demonstrate the contraceptive efficacy of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel and to observe cycle control and safety. Data from 805 treated women resulted in 4400 treatment cycles. One pregnancy occurred while on the trial medication as a result of method failure, resulting in a Pearl index of 0.29. Cycle control was good, and cycle length as well as duration and intensity of withdrawal bleeding were not significantly changed during the trial. Intermenstrual bleeding usually occurred as spotting and decreased considerably during the treatment phase. Spotting alone was reported in 12.4% of cycles, breakthrough bleeding alone in 4.5% of cycles, and breakthrough bleeding and spotting together in 1.4% of treatment cycles. The rate of absence of withdrawal bleeding declined throughout the trial to 2.4% in cycle 6. There were no serious adverse events related to treatment, and most adverse events were those commonly observed in clinical trials with oral contraceptives. Headache, breast tension, and nausea were reported by 17.3%, 11.0%, and 7.7% of the women, respectively. There were no clinically relevant changes in laboratory parameters, blood pressure, or weight. In this trial, the new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel was shown to be effective, safe, and well tolerated. Cycle control was found to be good and there was a low incidence of adverse events.</p>
</abstract>
<textClass>
<keywords scheme="keyword">
<list>
<head>Keywords</head>
<item>
<term>low dose oral contraceptive</term>
</item>
<item>
<term>efficacy</term>
</item>
<item>
<term>cycle control</term>
</item>
<item>
<term>side effects</term>
</item>
</list>
</keywords>
</textClass>
</profileDesc>
<revisionDesc>
<change when="1997-08-26">Modified</change>
<change when="1997">Published</change>
</revisionDesc>
</teiHeader>
</istex:fulltextTEI>
<json:item>
<extension>txt</extension>
<original>false</original>
<mimetype>text/plain</mimetype>
<uri>https://api.istex.fr/document/703BB529C9960DFFF15F67B3AD6A580DF371FBDB/fulltext/txt</uri>
</json:item>
</fulltext>
<metadata>
<istex:metadataXml wicri:clean="Elsevier, elements deleted: tail">
<istex:xmlDeclaration>version="1.0" encoding="utf-8"</istex:xmlDeclaration>
<istex:docType PUBLIC="-//ES//DTD journal article DTD version 4.5.2//EN//XML" URI="art452.dtd" name="istex:docType"></istex:docType>
<istex:document>
<converted-article version="4.5.2" docsubtype="fla">
<item-info>
<jid>CON</jid>
<aid>97001571</aid>
<ce:pii>S0010-7824(97)00157-1</ce:pii>
<ce:doi>10.1016/S0010-7824(97)00157-1</ce:doi>
<ce:copyright type="unknown" year="1997"></ce:copyright>
</item-info>
<head>
<ce:dochead>
<ce:textfn>Original research article</ce:textfn>
</ce:dochead>
<ce:title>A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel over six treatment cycles</ce:title>
<ce:author-group>
<ce:author>
<ce:given-name>R.</ce:given-name>
<ce:surname>Bannemerschult</ce:surname>
<ce:cross-ref refid="COR1">
<ce:sup>1</ce:sup>
</ce:cross-ref>
<ce:cross-ref refid="AFF1">
<ce:sup></ce:sup>
</ce:cross-ref>
</ce:author>
<ce:author>
<ce:given-name>J.P.</ce:given-name>
<ce:surname>Hanker</ce:surname>
<ce:cross-ref refid="AFF2">
<ce:sup></ce:sup>
</ce:cross-ref>
</ce:author>
<ce:author>
<ce:given-name>C.</ce:given-name>
<ce:surname>Wünsch</ce:surname>
<ce:cross-ref refid="AFF1">
<ce:sup></ce:sup>
</ce:cross-ref>
</ce:author>
<ce:author>
<ce:given-name>P.</ce:given-name>
<ce:surname>Fox</ce:surname>
<ce:cross-ref refid="AFF1">
<ce:sup></ce:sup>
</ce:cross-ref>
</ce:author>
<ce:author>
<ce:given-name>M.</ce:given-name>
<ce:surname>Albring</ce:surname>
<ce:cross-ref refid="AFF1">
<ce:sup></ce:sup>
</ce:cross-ref>
</ce:author>
<ce:author>
<ce:given-name>K.</ce:given-name>
<ce:surname>Brill</ce:surname>
<ce:cross-ref refid="AFF1">
<ce:sup></ce:sup>
</ce:cross-ref>
</ce:author>
<ce:affiliation id="AFF1">
<ce:label></ce:label>
<ce:textfn>Schering AG, German Operations, Berlin, Germany</ce:textfn>
</ce:affiliation>
<ce:affiliation id="AFF2">
<ce:label></ce:label>
<ce:textfn>Department of Obstetrics, Krankenanstalten der Mutter der Borromaerinnen, Trier, Germany.</ce:textfn>
</ce:affiliation>
<ce:correspondence id="COR1">
<ce:label>1</ce:label>
<ce:text>Name and address for correspondence: Dr. Ralf Bannemerschult, Schering AG. Geschäftsbereich Deutschland, Max-Dohrn-Straße 10, 13342 Berlin, Germany; Tel.: +49-30-3498-9105; Fax: +49-30-3498-9291</ce:text>
</ce:correspondence>
</ce:author-group>
<ce:date-received day="11" month="7" year="1997"></ce:date-received>
<ce:date-revised day="26" month="8" year="1997"></ce:date-revised>
<ce:date-accepted day="29" month="8" year="1997"></ce:date-accepted>
<ce:abstract>
<ce:section-title>Abstract</ce:section-title>
<ce:abstract-sec>
<ce:simple-para>The aim of the trial was to demonstrate the contraceptive efficacy of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel and to observe cycle control and safety. Data from 805 treated women resulted in 4400 treatment cycles. One pregnancy occurred while on the trial medication as a result of method failure, resulting in a Pearl index of 0.29. Cycle control was good, and cycle length as well as duration and intensity of withdrawal bleeding were not significantly changed during the trial. Intermenstrual bleeding usually occurred as spotting and decreased considerably during the treatment phase. Spotting alone was reported in 12.4% of cycles, breakthrough bleeding alone in 4.5% of cycles, and breakthrough bleeding and spotting together in 1.4% of treatment cycles. The rate of absence of withdrawal bleeding declined throughout the trial to 2.4% in cycle 6. There were no serious adverse events related to treatment, and most adverse events were those commonly observed in clinical trials with oral contraceptives. Headache, breast tension, and nausea were reported by 17.3%, 11.0%, and 7.7% of the women, respectively. There were no clinically relevant changes in laboratory parameters, blood pressure, or weight. In this trial, the new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel was shown to be effective, safe, and well tolerated. Cycle control was found to be good and there was a low incidence of adverse events.</ce:simple-para>
</ce:abstract-sec>
</ce:abstract>
<ce:keywords>
<ce:section-title>Keywords</ce:section-title>
<ce:keyword>
<ce:text>low dose oral contraceptive</ce:text>
</ce:keyword>
<ce:keyword>
<ce:text>efficacy</ce:text>
</ce:keyword>
<ce:keyword>
<ce:text>cycle control</ce:text>
</ce:keyword>
<ce:keyword>
<ce:text>side effects</ce:text>
</ce:keyword>
</ce:keywords>
</head>
</converted-article>
</istex:document>
</istex:metadataXml>
<mods version="3.6">
<titleInfo>
<title>A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel over six treatment cycles</title>
</titleInfo>
<titleInfo type="alternative" contentType="CDATA">
<title>A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel over six treatment cycles</title>
</titleInfo>
<name type="personal">
<namePart type="given">R.</namePart>
<namePart type="family">Bannemerschult</namePart>
<affiliation>Schering AG, German Operations, Berlin, Germany</affiliation>
<description>Name and address for correspondence: Dr. Ralf Bannemerschult, Schering AG. Geschäftsbereich Deutschland, Max-Dohrn-Straße 10, 13342 Berlin, Germany; Tel.: +49-30-3498-9105; Fax: +49-30-3498-9291</description>
<role>
<roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal">
<namePart type="given">J.P.</namePart>
<namePart type="family">Hanker</namePart>
<affiliation>Department of Obstetrics, Krankenanstalten der Mutter der Borromaerinnen, Trier, Germany.</affiliation>
<role>
<roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal">
<namePart type="given">C.</namePart>
<namePart type="family">Wünsch</namePart>
<affiliation>Schering AG, German Operations, Berlin, Germany</affiliation>
<role>
<roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal">
<namePart type="given">P.</namePart>
<namePart type="family">Fox</namePart>
<affiliation>Schering AG, German Operations, Berlin, Germany</affiliation>
<role>
<roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal">
<namePart type="given">M.</namePart>
<namePart type="family">Albring</namePart>
<affiliation>Schering AG, German Operations, Berlin, Germany</affiliation>
<role>
<roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal">
<namePart type="given">K.</namePart>
<namePart type="family">Brill</namePart>
<affiliation>Schering AG, German Operations, Berlin, Germany</affiliation>
<role>
<roleTerm type="text">author</roleTerm>
</role>
</name>
<typeOfResource>text</typeOfResource>
<genre type="research-article" displayLabel="Full-length article"></genre>
<originInfo>
<publisher>ELSEVIER</publisher>
<dateIssued encoding="w3cdtf">1997</dateIssued>
<dateModified encoding="w3cdtf">1997-08-26</dateModified>
<copyrightDate encoding="w3cdtf">1997</copyrightDate>
</originInfo>
<language>
<languageTerm type="code" authority="iso639-2b">eng</languageTerm>
<languageTerm type="code" authority="rfc3066">en</languageTerm>
</language>
<physicalDescription>
<internetMediaType>text/html</internetMediaType>
</physicalDescription>
<abstract lang="en">The aim of the trial was to demonstrate the contraceptive efficacy of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel and to observe cycle control and safety. Data from 805 treated women resulted in 4400 treatment cycles. One pregnancy occurred while on the trial medication as a result of method failure, resulting in a Pearl index of 0.29. Cycle control was good, and cycle length as well as duration and intensity of withdrawal bleeding were not significantly changed during the trial. Intermenstrual bleeding usually occurred as spotting and decreased considerably during the treatment phase. Spotting alone was reported in 12.4% of cycles, breakthrough bleeding alone in 4.5% of cycles, and breakthrough bleeding and spotting together in 1.4% of treatment cycles. The rate of absence of withdrawal bleeding declined throughout the trial to 2.4% in cycle 6. There were no serious adverse events related to treatment, and most adverse events were those commonly observed in clinical trials with oral contraceptives. Headache, breast tension, and nausea were reported by 17.3%, 11.0%, and 7.7% of the women, respectively. There were no clinically relevant changes in laboratory parameters, blood pressure, or weight. In this trial, the new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel was shown to be effective, safe, and well tolerated. Cycle control was found to be good and there was a low incidence of adverse events.</abstract>
<note type="content">Section title: Original research article</note>
<subject>
<genre>Keywords</genre>
<topic>low dose oral contraceptive</topic>
<topic>efficacy</topic>
<topic>cycle control</topic>
<topic>side effects</topic>
</subject>
<relatedItem type="host">
<titleInfo>
<title>Contraception</title>
</titleInfo>
<titleInfo type="abbreviated">
<title>CON</title>
</titleInfo>
<genre type="journal">journal</genre>
<originInfo>
<dateIssued encoding="w3cdtf">199711</dateIssued>
</originInfo>
<identifier type="ISSN">0010-7824</identifier>
<identifier type="PII">S0010-7824(00)X0034-0</identifier>
<part>
<date>199711</date>
<detail type="volume">
<number>56</number>
<caption>vol.</caption>
</detail>
<detail type="issue">
<number>5</number>
<caption>no.</caption>
</detail>
<extent unit="issue pages">
<start>275</start>
<end>340</end>
</extent>
<extent unit="pages">
<start>285</start>
<end>290</end>
</extent>
</part>
</relatedItem>
<identifier type="istex">703BB529C9960DFFF15F67B3AD6A580DF371FBDB</identifier>
<identifier type="DOI">10.1016/S0010-7824(97)00157-1</identifier>
<identifier type="PII">S0010-7824(97)00157-1</identifier>
<recordInfo>
<recordContentSource>ELSEVIER</recordContentSource>
</recordInfo>
</mods>
</metadata>
<serie></serie>
</istex>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Wicri/Rhénanie/explor/UnivTrevesV1/Data/Istex/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001049 | SxmlIndent | more

Ou

HfdSelect -h $EXPLOR_AREA/Data/Istex/Corpus/biblio.hfd -nk 001049 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Wicri/Rhénanie
   |area=    UnivTrevesV1
   |flux=    Istex
   |étape=   Corpus
   |type=    RBID
   |clé=     ISTEX:703BB529C9960DFFF15F67B3AD6A580DF371FBDB
   |texte=   A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel over six treatment cycles
}}

Wicri

This area was generated with Dilib version V0.6.31.
Data generation: Sat Jul 22 16:29:01 2017. Site generation: Wed Feb 28 14:55:37 2024