Tamoxifen for the treatment of breakthrough bleeding with the etonogestrel implant: a randomized controlled trial
Abstract Objective The etonogestrel (ENG) subdermal implant can cause frequent breakthrough bleeding in some users. The objective of this study was to evaluate whether a short course of tamoxifen reduces bleeding/spotting days compared to placebo in ENG implant users. Study design In this double-bli...
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| Veröffentlicht in: | Contraception (Stoneham) 2017-02, Vol.95 (2), p.198-204 |
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| creator | Simmons, Katharine B Edelman, Alison B Fu, Rongwei Jensen, Jeffrey T |
| description | Abstract Objective The etonogestrel (ENG) subdermal implant can cause frequent breakthrough bleeding in some users. The objective of this study was to evaluate whether a short course of tamoxifen reduces bleeding/spotting days compared to placebo in ENG implant users. Study design In this double-blind trial, we randomized ENG implant users with frequent or prolonged bleeding or spotting to tamoxifen 10 mg or placebo twice daily for 7 days, to be started after 3 consecutive days of bleeding/spotting. Treatment was repeated as needed up to three times in 180 days. Subjects completed a daily text message bleeding diary. A sample size of 56 provided 80% power to detect a difference of 6 days of bleeding/spotting per 30 days by two-sample t test. Ovulation was monitored by urinary metabolites of progesterone. Results From March 2014 to February 2015, 56 women enrolled. Fifty-one completed at least 30 days of follow up, and 34 completed 180 days. Compared to women randomized to placebo, women randomized to tamoxifen reported 5 fewer days of bleeding/spotting over 30 days (95% confidence interval [CI] −9.9 to −0.05, p=.05), and 15.2 more continuous bleeding-free days (95% CI 2.8–27.5 days, p=.02) after first use of study drug. Conclusions could not be drawn after 30 days due to higher-than-expected dropout. No ovulation was detected. Conclusion First use of tamoxifen by ENG implant users reduces bleeding/spotting days and provides a longer cessation of bleeding/spotting than placebo, without compromising ovulation suppression. Further study is needed to determine whether this effect is maintained with repeat use. Implications Women with frequent ENG implant-related breakthrough bleeding may experience a reduction in bleeding/spotting days and an increase in continuous bleeding-free days in the month following first use of tamoxifen. This short course of tamoxifen was well tolerated with bleeding cessation noted within a median of 5 days. |
| doi_str_mv | 10.1016/j.contraception.2016.10.001 |
| format | Article |
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The objective of this study was to evaluate whether a short course of tamoxifen reduces bleeding/spotting days compared to placebo in ENG implant users. Study design In this double-blind trial, we randomized ENG implant users with frequent or prolonged bleeding or spotting to tamoxifen 10 mg or placebo twice daily for 7 days, to be started after 3 consecutive days of bleeding/spotting. Treatment was repeated as needed up to three times in 180 days. Subjects completed a daily text message bleeding diary. A sample size of 56 provided 80% power to detect a difference of 6 days of bleeding/spotting per 30 days by two-sample t test. Ovulation was monitored by urinary metabolites of progesterone. Results From March 2014 to February 2015, 56 women enrolled. Fifty-one completed at least 30 days of follow up, and 34 completed 180 days. Compared to women randomized to placebo, women randomized to tamoxifen reported 5 fewer days of bleeding/spotting over 30 days (95% confidence interval [CI] −9.9 to −0.05, p=.05), and 15.2 more continuous bleeding-free days (95% CI 2.8–27.5 days, p=.02) after first use of study drug. Conclusions could not be drawn after 30 days due to higher-than-expected dropout. No ovulation was detected. Conclusion First use of tamoxifen by ENG implant users reduces bleeding/spotting days and provides a longer cessation of bleeding/spotting than placebo, without compromising ovulation suppression. Further study is needed to determine whether this effect is maintained with repeat use. Implications Women with frequent ENG implant-related breakthrough bleeding may experience a reduction in bleeding/spotting days and an increase in continuous bleeding-free days in the month following first use of tamoxifen. This short course of tamoxifen was well tolerated with bleeding cessation noted within a median of 5 days.</description><identifier>ISSN: 0010-7824</identifier><identifier>EISSN: 1879-0518</identifier><identifier>DOI: 10.1016/j.contraception.2016.10.001</identifier><identifier>PMID: 27725164</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adolescent ; Adult ; Breakthrough bleeding ; Contraception ; Contraceptive Agents, Female ; Desogestrel - administration & dosage ; Desogestrel - adverse effects ; Double-Blind Method ; Drug Implants ; Etonogestrel implant ; Female ; Humans ; Metrorrhagia - chemically induced ; Metrorrhagia - drug therapy ; Middle Aged ; Obstetrics and Gynecology ; Ovulation - urine ; Placebos ; Progesterone - urine ; Tamoxifen ; Tamoxifen - therapeutic use ; Uterine Hemorrhage ; Young Adult</subject><ispartof>Contraception (Stoneham), 2017-02, Vol.95 (2), p.198-204</ispartof><rights>Elsevier Inc.</rights><rights>2017 Elsevier Inc.</rights><rights>Copyright © 2017 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c423t-420c1df35f4e55cec7dbdffb86cee40405221e4aeb4c0497ce3b3a2d3dff27963</citedby><cites>FETCH-LOGICAL-c423t-420c1df35f4e55cec7dbdffb86cee40405221e4aeb4c0497ce3b3a2d3dff27963</cites><orcidid>0000-0002-4733-1224</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.contraception.2016.10.001$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27725164$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Simmons, Katharine B</creatorcontrib><creatorcontrib>Edelman, Alison B</creatorcontrib><creatorcontrib>Fu, Rongwei</creatorcontrib><creatorcontrib>Jensen, Jeffrey T</creatorcontrib><title>Tamoxifen for the treatment of breakthrough bleeding with the etonogestrel implant: a randomized controlled trial</title><title>Contraception (Stoneham)</title><addtitle>Contraception</addtitle><description>Abstract Objective The etonogestrel (ENG) subdermal implant can cause frequent breakthrough bleeding in some users. The objective of this study was to evaluate whether a short course of tamoxifen reduces bleeding/spotting days compared to placebo in ENG implant users. Study design In this double-blind trial, we randomized ENG implant users with frequent or prolonged bleeding or spotting to tamoxifen 10 mg or placebo twice daily for 7 days, to be started after 3 consecutive days of bleeding/spotting. Treatment was repeated as needed up to three times in 180 days. Subjects completed a daily text message bleeding diary. A sample size of 56 provided 80% power to detect a difference of 6 days of bleeding/spotting per 30 days by two-sample t test. Ovulation was monitored by urinary metabolites of progesterone. Results From March 2014 to February 2015, 56 women enrolled. Fifty-one completed at least 30 days of follow up, and 34 completed 180 days. Compared to women randomized to placebo, women randomized to tamoxifen reported 5 fewer days of bleeding/spotting over 30 days (95% confidence interval [CI] −9.9 to −0.05, p=.05), and 15.2 more continuous bleeding-free days (95% CI 2.8–27.5 days, p=.02) after first use of study drug. Conclusions could not be drawn after 30 days due to higher-than-expected dropout. No ovulation was detected. Conclusion First use of tamoxifen by ENG implant users reduces bleeding/spotting days and provides a longer cessation of bleeding/spotting than placebo, without compromising ovulation suppression. Further study is needed to determine whether this effect is maintained with repeat use. Implications Women with frequent ENG implant-related breakthrough bleeding may experience a reduction in bleeding/spotting days and an increase in continuous bleeding-free days in the month following first use of tamoxifen. This short course of tamoxifen was well tolerated with bleeding cessation noted within a median of 5 days.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Breakthrough bleeding</subject><subject>Contraception</subject><subject>Contraceptive Agents, Female</subject><subject>Desogestrel - administration & dosage</subject><subject>Desogestrel - adverse effects</subject><subject>Double-Blind Method</subject><subject>Drug Implants</subject><subject>Etonogestrel implant</subject><subject>Female</subject><subject>Humans</subject><subject>Metrorrhagia - chemically induced</subject><subject>Metrorrhagia - drug therapy</subject><subject>Middle Aged</subject><subject>Obstetrics and Gynecology</subject><subject>Ovulation - urine</subject><subject>Placebos</subject><subject>Progesterone - urine</subject><subject>Tamoxifen</subject><subject>Tamoxifen - therapeutic use</subject><subject>Uterine Hemorrhage</subject><subject>Young Adult</subject><issn>0010-7824</issn><issn>1879-0518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkU1v1DAQhi0EokvhLyBLXLhk8VfiBCQkVJUWqRKHtmfLcSa73jr21naA8utxuqVSOXGyPfPOzOtnEHpHyZoS2nzYrU3wOWoD-2yDX7MSLJk1IfQZWtFWdhWpafscrUqEVLJl4gi9SmlHCJFdLV-iIyYlq2kjVuj2Sk_hlx3B4zFEnLeAcwSdJ_AZhxH35XGTtzHMmy3uHcBg_Qb_tHl7r4UcfNhAKjUO22nvtM8fscZR-yFM9jcM-N5scK5cc7TavUYvRu0SvHk4j9H119Ork_Pq4vvZt5MvF5URjOdKMGLoMPJ6FFDXBowc-mEc-7YxAIIIUjNGQWjohSGikwZ4zzUbeBEx2TX8GL0_9N3HcDsXi2qyyYArFiHMSdGW17xjrJNF-ukgNTGkFGFU-2gnHe8UJWphrnbqCXO1MF-ShXCpfvswaO4nGB5r_0IugtODAMp3f1iIKhkL3hSWEUxWQ7D_OejzP32Ms94a7W7gDtIuzNEXooqqxBRRl8v6l-3ThhMhGsb_AEaDswo</recordid><startdate>20170201</startdate><enddate>20170201</enddate><creator>Simmons, Katharine B</creator><creator>Edelman, Alison B</creator><creator>Fu, Rongwei</creator><creator>Jensen, Jeffrey T</creator><general>Elsevier Inc</general><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><orcidid>https://orcid.org/0000-0002-4733-1224</orcidid></search><sort><creationdate>20170201</creationdate><title>Tamoxifen for the treatment of breakthrough bleeding with the etonogestrel implant: a randomized controlled trial</title><author>Simmons, Katharine B ; Edelman, Alison B ; Fu, Rongwei ; Jensen, Jeffrey T</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c423t-420c1df35f4e55cec7dbdffb86cee40405221e4aeb4c0497ce3b3a2d3dff27963</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Breakthrough bleeding</topic><topic>Contraception</topic><topic>Contraceptive Agents, Female</topic><topic>Desogestrel - administration & dosage</topic><topic>Desogestrel - adverse effects</topic><topic>Double-Blind Method</topic><topic>Drug Implants</topic><topic>Etonogestrel implant</topic><topic>Female</topic><topic>Humans</topic><topic>Metrorrhagia - chemically induced</topic><topic>Metrorrhagia - drug therapy</topic><topic>Middle Aged</topic><topic>Obstetrics and Gynecology</topic><topic>Ovulation - urine</topic><topic>Placebos</topic><topic>Progesterone - urine</topic><topic>Tamoxifen</topic><topic>Tamoxifen - therapeutic use</topic><topic>Uterine Hemorrhage</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Simmons, Katharine B</creatorcontrib><creatorcontrib>Edelman, Alison B</creatorcontrib><creatorcontrib>Fu, Rongwei</creatorcontrib><creatorcontrib>Jensen, Jeffrey T</creatorcontrib><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>Contraception (Stoneham)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Simmons, Katharine B</au><au>Edelman, Alison B</au><au>Fu, Rongwei</au><au>Jensen, Jeffrey T</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Tamoxifen for the treatment of breakthrough bleeding with the etonogestrel implant: a randomized controlled trial</atitle><jtitle>Contraception (Stoneham)</jtitle><addtitle>Contraception</addtitle><date>2017-02-01</date><risdate>2017</risdate><volume>95</volume><issue>2</issue><spage>198</spage><epage>204</epage><pages>198-204</pages><issn>0010-7824</issn><eissn>1879-0518</eissn><abstract>Abstract Objective The etonogestrel (ENG) subdermal implant can cause frequent breakthrough bleeding in some users. The objective of this study was to evaluate whether a short course of tamoxifen reduces bleeding/spotting days compared to placebo in ENG implant users. Study design In this double-blind trial, we randomized ENG implant users with frequent or prolonged bleeding or spotting to tamoxifen 10 mg or placebo twice daily for 7 days, to be started after 3 consecutive days of bleeding/spotting. Treatment was repeated as needed up to three times in 180 days. Subjects completed a daily text message bleeding diary. A sample size of 56 provided 80% power to detect a difference of 6 days of bleeding/spotting per 30 days by two-sample t test. Ovulation was monitored by urinary metabolites of progesterone. Results From March 2014 to February 2015, 56 women enrolled. Fifty-one completed at least 30 days of follow up, and 34 completed 180 days. Compared to women randomized to placebo, women randomized to tamoxifen reported 5 fewer days of bleeding/spotting over 30 days (95% confidence interval [CI] −9.9 to −0.05, p=.05), and 15.2 more continuous bleeding-free days (95% CI 2.8–27.5 days, p=.02) after first use of study drug. Conclusions could not be drawn after 30 days due to higher-than-expected dropout. No ovulation was detected. Conclusion First use of tamoxifen by ENG implant users reduces bleeding/spotting days and provides a longer cessation of bleeding/spotting than placebo, without compromising ovulation suppression. Further study is needed to determine whether this effect is maintained with repeat use. Implications Women with frequent ENG implant-related breakthrough bleeding may experience a reduction in bleeding/spotting days and an increase in continuous bleeding-free days in the month following first use of tamoxifen. This short course of tamoxifen was well tolerated with bleeding cessation noted within a median of 5 days.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>27725164</pmid><doi>10.1016/j.contraception.2016.10.001</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-4733-1224</orcidid></addata></record> |
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| subjects | Adolescent Adult Breakthrough bleeding Contraception Contraceptive Agents, Female Desogestrel - administration & dosage Desogestrel - adverse effects Double-Blind Method Drug Implants Etonogestrel implant Female Humans Metrorrhagia - chemically induced Metrorrhagia - drug therapy Middle Aged Obstetrics and Gynecology Ovulation - urine Placebos Progesterone - urine Tamoxifen Tamoxifen - therapeutic use Uterine Hemorrhage Young Adult |
| title | Tamoxifen for the treatment of breakthrough bleeding with the etonogestrel implant: a randomized controlled trial |
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