Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment. Petraglia, F., Hornung, D., Seitz, C., Faustmann, T., Gerlinger, C., Luisi, S., Lazzeri, L., & Strowitzki, T. Archives of Gynecology and Obstetrics, 285(1):167--173, January, 2012. doi abstract bibtex PURPOSE: To investigate the efficacy and safety of dienogest as a long-term treatment in endometriosis, with follow-up after treatment discontinuation. The study included women with endometriosis, who had previously completed a 12-week, placebo-controlled study of dienogest, who participated in an open-label extension study for up to 53 weeks. Thereafter, a patient subgroup was evaluated in a 24-week follow-up after treatment discontinuation. METHODS: A multicenter study performed in Germany, Italy and Ukraine. Women with endometriosis were enrolled at completion of the placebo-controlled study (n = 168). All women received dienogest (2 mg once daily, orally) and changes in pelvic pain (on a visual analog scale), bleeding pattern, adverse events and laboratory parameters were evaluated during and after treatment. RESULTS: The completion rate among women who entered the open-label extension study was 90.5% (n = 152). A significant decrease in pelvic pain was shown during continued dienogest treatment (P \textless 0.001). The mean frequency and intensity of bleeding progressively decreased. Adverse events, rated generally mild or moderate, led to withdrawal in four patients (2.4%). No clinically relevant changes in laboratory parameters were observed. During treatment-free follow-up (n = 34), the reduction in pelvic pain persisted, while bleeding frequency and intensity returned to normal patterns. CONCLUSIONS: Long-term dienogest showed a favorable efficacy and safety profile, with progressive decreases in pain and bleeding irregularities during continued treatment; the decrease of pelvic pain persisted for at least 24 weeks after treatment cessation.
@article{petraglia_reduced_2012,
title = {Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment},
volume = {285},
issn = {1432-0711},
shorttitle = {Reduced pelvic pain in women with endometriosis},
doi = {10.1007/s00404-011-1941-7},
abstract = {PURPOSE: To investigate the efficacy and safety of dienogest as a long-term treatment in endometriosis, with follow-up after treatment discontinuation. The study included women with endometriosis, who had previously completed a 12-week, placebo-controlled study of dienogest, who participated in an open-label extension study for up to 53 weeks. Thereafter, a patient subgroup was evaluated in a 24-week follow-up after treatment discontinuation.
METHODS: A multicenter study performed in Germany, Italy and Ukraine. Women with endometriosis were enrolled at completion of the placebo-controlled study (n = 168). All women received dienogest (2 mg once daily, orally) and changes in pelvic pain (on a visual analog scale), bleeding pattern, adverse events and laboratory parameters were evaluated during and after treatment.
RESULTS: The completion rate among women who entered the open-label extension study was 90.5\% (n = 152). A significant decrease in pelvic pain was shown during continued dienogest treatment (P {\textless} 0.001). The mean frequency and intensity of bleeding progressively decreased. Adverse events, rated generally mild or moderate, led to withdrawal in four patients (2.4\%). No clinically relevant changes in laboratory parameters were observed. During treatment-free follow-up (n = 34), the reduction in pelvic pain persisted, while bleeding frequency and intensity returned to normal patterns.
CONCLUSIONS: Long-term dienogest showed a favorable efficacy and safety profile, with progressive decreases in pain and bleeding irregularities during continued treatment; the decrease of pelvic pain persisted for at least 24 weeks after treatment cessation.},
language = {eng},
number = {1},
journal = {Archives of Gynecology and Obstetrics},
author = {Petraglia, Felice and Hornung, Daniela and Seitz, Christian and Faustmann, Thomas and Gerlinger, Christoph and Luisi, Stefano and Lazzeri, Lucia and Strowitzki, Thomas},
month = jan,
year = {2012},
pmid = {21681516},
pmcid = {PMC3249203},
keywords = {Adolescent, Adult, Drug Administration Schedule, Endometriosis, Female, Follow-Up Studies, Germany, Hormone Antagonists, Humans, Italy, Middle Aged, Nandrolone, Pelvic Pain, Ukraine, Young Adult},
pages = {167--173}
}
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The study included women with endometriosis, who had previously completed a 12-week, placebo-controlled study of dienogest, who participated in an open-label extension study for up to 53 weeks. Thereafter, a patient subgroup was evaluated in a 24-week follow-up after treatment discontinuation. METHODS: A multicenter study performed in Germany, Italy and Ukraine. Women with endometriosis were enrolled at completion of the placebo-controlled study (n = 168). All women received dienogest (2 mg once daily, orally) and changes in pelvic pain (on a visual analog scale), bleeding pattern, adverse events and laboratory parameters were evaluated during and after treatment. RESULTS: The completion rate among women who entered the open-label extension study was 90.5% (n = 152). A significant decrease in pelvic pain was shown during continued dienogest treatment (P \\textless 0.001). The mean frequency and intensity of bleeding progressively decreased. Adverse events, rated generally mild or moderate, led to withdrawal in four patients (2.4%). No clinically relevant changes in laboratory parameters were observed. During treatment-free follow-up (n = 34), the reduction in pelvic pain persisted, while bleeding frequency and intensity returned to normal patterns. CONCLUSIONS: Long-term dienogest showed a favorable efficacy and safety profile, with progressive decreases in pain and bleeding irregularities during continued treatment; the decrease of pelvic pain persisted for at least 24 weeks after treatment cessation.","language":"eng","number":"1","journal":"Archives of Gynecology and Obstetrics","author":[{"propositions":[],"lastnames":["Petraglia"],"firstnames":["Felice"],"suffixes":[]},{"propositions":[],"lastnames":["Hornung"],"firstnames":["Daniela"],"suffixes":[]},{"propositions":[],"lastnames":["Seitz"],"firstnames":["Christian"],"suffixes":[]},{"propositions":[],"lastnames":["Faustmann"],"firstnames":["Thomas"],"suffixes":[]},{"propositions":[],"lastnames":["Gerlinger"],"firstnames":["Christoph"],"suffixes":[]},{"propositions":[],"lastnames":["Luisi"],"firstnames":["Stefano"],"suffixes":[]},{"propositions":[],"lastnames":["Lazzeri"],"firstnames":["Lucia"],"suffixes":[]},{"propositions":[],"lastnames":["Strowitzki"],"firstnames":["Thomas"],"suffixes":[]}],"month":"January","year":"2012","pmid":"21681516","pmcid":"PMC3249203","keywords":"Adolescent, Adult, Drug Administration Schedule, Endometriosis, Female, Follow-Up Studies, Germany, Hormone Antagonists, Humans, Italy, Middle Aged, Nandrolone, Pelvic Pain, Ukraine, Young Adult","pages":"167--173","bibtex":"@article{petraglia_reduced_2012,\n\ttitle = {Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment},\n\tvolume = {285},\n\tissn = {1432-0711},\n\tshorttitle = {Reduced pelvic pain in women with endometriosis},\n\tdoi = {10.1007/s00404-011-1941-7},\n\tabstract = {PURPOSE: To investigate the efficacy and safety of dienogest as a long-term treatment in endometriosis, with follow-up after treatment discontinuation. The study included women with endometriosis, who had previously completed a 12-week, placebo-controlled study of dienogest, who participated in an open-label extension study for up to 53 weeks. Thereafter, a patient subgroup was evaluated in a 24-week follow-up after treatment discontinuation.\nMETHODS: A multicenter study performed in Germany, Italy and Ukraine. Women with endometriosis were enrolled at completion of the placebo-controlled study (n = 168). All women received dienogest (2 mg once daily, orally) and changes in pelvic pain (on a visual analog scale), bleeding pattern, adverse events and laboratory parameters were evaluated during and after treatment.\nRESULTS: The completion rate among women who entered the open-label extension study was 90.5\\% (n = 152). A significant decrease in pelvic pain was shown during continued dienogest treatment (P {\\textless} 0.001). The mean frequency and intensity of bleeding progressively decreased. Adverse events, rated generally mild or moderate, led to withdrawal in four patients (2.4\\%). No clinically relevant changes in laboratory parameters were observed. 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