Bleeding profile and safety of a levonorgestrel 13.5 mg intrauterine device versus Nova T copper 380 mm2 intrauterine device: Results of a 3-year, single-center, randomized phase 4 study
To assess the bleeding profiles of the levonorgestrel 13.5 mg intrauterine device (LNG13.5-IUD) and Nova T copper 380 mm2 IUD (Cu380-IUD). Single-center, evaluator-masked, randomized study conducted in women aged 18–45 years starting these methods. Primary outcomes were number of bleeding days, self...
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| Veröffentlicht in: | Contraception (Stoneham) 2023-11, Vol.127, p.110127-110127, Article 110127 |
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| creator | Perelló-Capó, Josep Estadella-Tarriel, Josep Gich-Saladich, Ignasi Bailón-Queiruga, Marta Llurba-Olivé, Elisa Calaf-Alsina, Joaquim |
| description | To assess the bleeding profiles of the levonorgestrel 13.5 mg intrauterine device (LNG13.5-IUD) and Nova T copper 380 mm2 IUD (Cu380-IUD).
Single-center, evaluator-masked, randomized study conducted in women aged 18–45 years starting these methods. Primary outcomes were number of bleeding days, self-reported bleeding intensity, Pictorial Blood Assessment Chart (PBAC) score, and blood biochemical values at baseline, months 3, 6, 12, 24, and 36 per 90-day reference periods except for PBAC (months). Secondary objectives were presence/duration/intensity of dysmenorrhea and tolerability.
We included 106 women aged 32.5 ± 6.7 years: 55 with LNG13.5-IUD and 51 with Cu380-IUD. Data for LNG13.5-IUD versus Cu380-IUD at baseline and month 36 (both respectively) were as follows: (1) median (25th; 75th percentile) number of bleeding days: 12 (9.0; 15.0) versus 12 (9.0; 15.0), p = 0.82, and 4 (0; 13.7) versus 15 (14.2; 20.0), p |
| doi_str_mv | 10.1016/j.contraception.2023.110127 |
| format | Article |
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Single-center, evaluator-masked, randomized study conducted in women aged 18–45 years starting these methods. Primary outcomes were number of bleeding days, self-reported bleeding intensity, Pictorial Blood Assessment Chart (PBAC) score, and blood biochemical values at baseline, months 3, 6, 12, 24, and 36 per 90-day reference periods except for PBAC (months). Secondary objectives were presence/duration/intensity of dysmenorrhea and tolerability.
We included 106 women aged 32.5 ± 6.7 years: 55 with LNG13.5-IUD and 51 with Cu380-IUD. Data for LNG13.5-IUD versus Cu380-IUD at baseline and month 36 (both respectively) were as follows: (1) median (25th; 75th percentile) number of bleeding days: 12 (9.0; 15.0) versus 12 (9.0; 15.0), p = 0.82, and 4 (0; 13.7) versus 15 (14.2; 20.0), p < 0.001; (2) mean bleeding intensity: 1.7 for both, p = 0.66, and 0.7 and 2.2, p < 0.001. Forty percent versus 0% presented with amenorrhea at month 36; (3) mean PBAC score (95% Confidence interval (CI): 50.7 (16.6; 84.7) versus 130.4 (95.7; 165.0) at month 1, and 7.9 (−26.7; 42.6) versus 126 (90.7; 161.2), p < 0.001; (4) median (25th; 75th percentile) ferritin levels (Ug/L) 33 (19; 53) versus 30 (19; 45), p = 0.70, and 59 (42; 84) versus 21 (8; 39). We did not observe changes or differences between groups in hemoglobin and hematocrit. The duration and intensity of dysmenorrhea were significantly lower with LNG13.5-IUD versus Cu380-IUD. Adverse events were those expected.
LNG13.5-IUD is associated with a significant reduction in blood loss and dysmenorrhea compared with Cu380-IUD.
Women eligible for a levonorgestrel 13.5 mg intrauterine device (IUD) or a copper 380 mm2 IUD should be informed of the differences in bleeding profiles—one of the main causes for IUD discontinuation—so they can compare this information against their bleeding expectations.</description><identifier>ISSN: 0010-7824</identifier><identifier>EISSN: 1879-0518</identifier><identifier>DOI: 10.1016/j.contraception.2023.110127</identifier><language>eng</language><publisher>Elsevier Inc</publisher><subject>Bleeding ; Contraception ; Copper intrauterine contraceptive device ; Hormonal contraception ; Hormone-releasing intrauterine contraceptive device ; Long-acting reversible contraception</subject><ispartof>Contraception (Stoneham), 2023-11, Vol.127, p.110127-110127, Article 110127</ispartof><rights>2023 Elsevier Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c290t-a2c225bd1eab71de147912ecc56c32925c0f36c2bad2cab94e37b0c59feb02033</citedby><cites>FETCH-LOGICAL-c290t-a2c225bd1eab71de147912ecc56c32925c0f36c2bad2cab94e37b0c59feb02033</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0010782423002214$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids></links><search><creatorcontrib>Perelló-Capó, Josep</creatorcontrib><creatorcontrib>Estadella-Tarriel, Josep</creatorcontrib><creatorcontrib>Gich-Saladich, Ignasi</creatorcontrib><creatorcontrib>Bailón-Queiruga, Marta</creatorcontrib><creatorcontrib>Llurba-Olivé, Elisa</creatorcontrib><creatorcontrib>Calaf-Alsina, Joaquim</creatorcontrib><title>Bleeding profile and safety of a levonorgestrel 13.5 mg intrauterine device versus Nova T copper 380 mm2 intrauterine device: Results of a 3-year, single-center, randomized phase 4 study</title><title>Contraception (Stoneham)</title><description>To assess the bleeding profiles of the levonorgestrel 13.5 mg intrauterine device (LNG13.5-IUD) and Nova T copper 380 mm2 IUD (Cu380-IUD).
Single-center, evaluator-masked, randomized study conducted in women aged 18–45 years starting these methods. Primary outcomes were number of bleeding days, self-reported bleeding intensity, Pictorial Blood Assessment Chart (PBAC) score, and blood biochemical values at baseline, months 3, 6, 12, 24, and 36 per 90-day reference periods except for PBAC (months). Secondary objectives were presence/duration/intensity of dysmenorrhea and tolerability.
We included 106 women aged 32.5 ± 6.7 years: 55 with LNG13.5-IUD and 51 with Cu380-IUD. Data for LNG13.5-IUD versus Cu380-IUD at baseline and month 36 (both respectively) were as follows: (1) median (25th; 75th percentile) number of bleeding days: 12 (9.0; 15.0) versus 12 (9.0; 15.0), p = 0.82, and 4 (0; 13.7) versus 15 (14.2; 20.0), p < 0.001; (2) mean bleeding intensity: 1.7 for both, p = 0.66, and 0.7 and 2.2, p < 0.001. Forty percent versus 0% presented with amenorrhea at month 36; (3) mean PBAC score (95% Confidence interval (CI): 50.7 (16.6; 84.7) versus 130.4 (95.7; 165.0) at month 1, and 7.9 (−26.7; 42.6) versus 126 (90.7; 161.2), p < 0.001; (4) median (25th; 75th percentile) ferritin levels (Ug/L) 33 (19; 53) versus 30 (19; 45), p = 0.70, and 59 (42; 84) versus 21 (8; 39). We did not observe changes or differences between groups in hemoglobin and hematocrit. The duration and intensity of dysmenorrhea were significantly lower with LNG13.5-IUD versus Cu380-IUD. Adverse events were those expected.
LNG13.5-IUD is associated with a significant reduction in blood loss and dysmenorrhea compared with Cu380-IUD.
Women eligible for a levonorgestrel 13.5 mg intrauterine device (IUD) or a copper 380 mm2 IUD should be informed of the differences in bleeding profiles—one of the main causes for IUD discontinuation—so they can compare this information against their bleeding expectations.</description><subject>Bleeding</subject><subject>Contraception</subject><subject>Copper intrauterine contraceptive device</subject><subject>Hormonal contraception</subject><subject>Hormone-releasing intrauterine contraceptive device</subject><subject>Long-acting reversible contraception</subject><issn>0010-7824</issn><issn>1879-0518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNqNkU2O1DAQhSMEEs3AHUpiw2KS8U_SSWAFo2FAGoGEhrXllCuNW0kcbCdSz2k4CCtOhlthg8SCVS3qvfp5X5a95KzgjO-vjgW6KXqNNEfrpkIwIQueWqJ-lO14U7c5q3jzONsxxlleN6J8mj0L4cgYq9uq3mU_3w1Exk4HmL3r7UCgJwNB9xRP4HrQMNDqJucPFKKnAbgsql8_xgPY8-IlkrcTgaHVIsFKPiwBPrlVwz2gm2fyIBuWDKP4l-M1fKGwDDFsu2R-Iu0vIaSDBsqRpqS-BJ9ucqN9IAPzNx0ISghxMafn2ZNeD4Fe_KkX2df3N_fXH_K7z7cfr9_e5ShaFnMtUIiqM5x0V3NDvKxbLgix2qMUraiQ9XKPotNGoO7akmTdMazanjommJQX2attbsro-5KCUKMNSMOgJ3JLUKIpedOwquZJ-maToncheOrV7O2o_Ulxps7M1FH9xUydmamNWXLfbG5K36yWvApoacJEyBNGZZz9rzm_ASQcrFg</recordid><startdate>202311</startdate><enddate>202311</enddate><creator>Perelló-Capó, Josep</creator><creator>Estadella-Tarriel, Josep</creator><creator>Gich-Saladich, Ignasi</creator><creator>Bailón-Queiruga, Marta</creator><creator>Llurba-Olivé, Elisa</creator><creator>Calaf-Alsina, Joaquim</creator><general>Elsevier Inc</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202311</creationdate><title>Bleeding profile and safety of a levonorgestrel 13.5 mg intrauterine device versus Nova T copper 380 mm2 intrauterine device: Results of a 3-year, single-center, randomized phase 4 study</title><author>Perelló-Capó, Josep ; Estadella-Tarriel, Josep ; Gich-Saladich, Ignasi ; Bailón-Queiruga, Marta ; Llurba-Olivé, Elisa ; Calaf-Alsina, Joaquim</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c290t-a2c225bd1eab71de147912ecc56c32925c0f36c2bad2cab94e37b0c59feb02033</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Bleeding</topic><topic>Contraception</topic><topic>Copper intrauterine contraceptive device</topic><topic>Hormonal contraception</topic><topic>Hormone-releasing intrauterine contraceptive device</topic><topic>Long-acting reversible contraception</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Perelló-Capó, Josep</creatorcontrib><creatorcontrib>Estadella-Tarriel, Josep</creatorcontrib><creatorcontrib>Gich-Saladich, Ignasi</creatorcontrib><creatorcontrib>Bailón-Queiruga, Marta</creatorcontrib><creatorcontrib>Llurba-Olivé, Elisa</creatorcontrib><creatorcontrib>Calaf-Alsina, Joaquim</creatorcontrib><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Contraception (Stoneham)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Perelló-Capó, Josep</au><au>Estadella-Tarriel, Josep</au><au>Gich-Saladich, Ignasi</au><au>Bailón-Queiruga, Marta</au><au>Llurba-Olivé, Elisa</au><au>Calaf-Alsina, Joaquim</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Bleeding profile and safety of a levonorgestrel 13.5 mg intrauterine device versus Nova T copper 380 mm2 intrauterine device: Results of a 3-year, single-center, randomized phase 4 study</atitle><jtitle>Contraception (Stoneham)</jtitle><date>2023-11</date><risdate>2023</risdate><volume>127</volume><spage>110127</spage><epage>110127</epage><pages>110127-110127</pages><artnum>110127</artnum><issn>0010-7824</issn><eissn>1879-0518</eissn><abstract>To assess the bleeding profiles of the levonorgestrel 13.5 mg intrauterine device (LNG13.5-IUD) and Nova T copper 380 mm2 IUD (Cu380-IUD).
Single-center, evaluator-masked, randomized study conducted in women aged 18–45 years starting these methods. Primary outcomes were number of bleeding days, self-reported bleeding intensity, Pictorial Blood Assessment Chart (PBAC) score, and blood biochemical values at baseline, months 3, 6, 12, 24, and 36 per 90-day reference periods except for PBAC (months). Secondary objectives were presence/duration/intensity of dysmenorrhea and tolerability.
We included 106 women aged 32.5 ± 6.7 years: 55 with LNG13.5-IUD and 51 with Cu380-IUD. Data for LNG13.5-IUD versus Cu380-IUD at baseline and month 36 (both respectively) were as follows: (1) median (25th; 75th percentile) number of bleeding days: 12 (9.0; 15.0) versus 12 (9.0; 15.0), p = 0.82, and 4 (0; 13.7) versus 15 (14.2; 20.0), p < 0.001; (2) mean bleeding intensity: 1.7 for both, p = 0.66, and 0.7 and 2.2, p < 0.001. Forty percent versus 0% presented with amenorrhea at month 36; (3) mean PBAC score (95% Confidence interval (CI): 50.7 (16.6; 84.7) versus 130.4 (95.7; 165.0) at month 1, and 7.9 (−26.7; 42.6) versus 126 (90.7; 161.2), p < 0.001; (4) median (25th; 75th percentile) ferritin levels (Ug/L) 33 (19; 53) versus 30 (19; 45), p = 0.70, and 59 (42; 84) versus 21 (8; 39). We did not observe changes or differences between groups in hemoglobin and hematocrit. The duration and intensity of dysmenorrhea were significantly lower with LNG13.5-IUD versus Cu380-IUD. Adverse events were those expected.
LNG13.5-IUD is associated with a significant reduction in blood loss and dysmenorrhea compared with Cu380-IUD.
Women eligible for a levonorgestrel 13.5 mg intrauterine device (IUD) or a copper 380 mm2 IUD should be informed of the differences in bleeding profiles—one of the main causes for IUD discontinuation—so they can compare this information against their bleeding expectations.</abstract><pub>Elsevier Inc</pub><doi>10.1016/j.contraception.2023.110127</doi><tpages>1</tpages></addata></record> |
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| subjects | Bleeding Contraception Copper intrauterine contraceptive device Hormonal contraception Hormone-releasing intrauterine contraceptive device Long-acting reversible contraception |
| title | Bleeding profile and safety of a levonorgestrel 13.5 mg intrauterine device versus Nova T copper 380 mm2 intrauterine device: Results of a 3-year, single-center, randomized phase 4 study |
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