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Safety and Effectiveness of Dienogest (Visanne®) for Treatment of Endometriosis: A Large Prospective Cohort Study

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Abstract

Dienogest (DNG) is a progestin with highly selective progesterone activity and known to be effective in the treatment of endometriosis. This prospective cohort study in patients who had been treated with DNG 2 mg (Visanne®) for endometriosis was conducted to assess the safety and effectiveness of DNG in a large Korean cohort. This study included 3356 patients with endometriosis from 73 centers in Korea. All patients were treated with DNG 2 mg daily and were followed up for at least 6 months after initial visit. Any adverse events were recorded including severity, onset/closing date, outcomes, treatments, and the causality with DNG. Effectiveness of DNG was measured by changes in visual analogue scale (VAS) from baseline at the end of follow-up. The mean age of the subjects was 34.96 years, and the mean duration of treatment was 285.44 days. Incidence of adverse drug reaction (ADR) was 13.27% (413/3113). The most frequently reported ADR were “abnormal uterine bleeding” 4.14% (129/3113), “increased weight” 2.57% (80/3113), and “headache” 1.22% (38/3113). The number of patients (%) with favorable bleeding patterns was observed to increase as the duration of treatment increases. Amenorrhea was observed in 29.63%, 41.25%, 46.26%, and 53.20% of patients at 3 months, 6 months, 12 months, and more than 12 months follow-up period, respectively. The mean (±SD) VAS change from baseline at the last follow-up visit was −28.19 ± 28.39 mm (P value < 0.0001). This large cohort study confirms, in routine clinical practice, that DNG is safe and effective for treatment of endometriosis.

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Funding

Funding for this study was provided by Bayer Korea Ltd.

Editorial support was provided by Honorem, which was funded by Bayer Korea Ltd.

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Authors and Affiliations

  1. Medical Affairs Women’s Healthcare, Bayer Korea Ltd. Pharmaceutical, Seoul, Republic of Korea

    BaikSeol Cho

  2. Department of Obstetrics and Gynecology, Dongguk University Ilsan Hospital, Gyeonggi-do, Republic of Korea

    Ju-Won Roh

  3. Department of Obstetrics and Gynecology, Ilsin Christian Hospital, Busan, Republic of Korea

    Jonghoon Park

  4. Department of Obstetrics and Gynecology, Bonseng Memorial Hospital, Busan, Republic of Korea

    Jonghoon Park

  5. Department of Obstetrics and Gynecology, College of Medicine, Ewha Womans University Mokdong Hospital, Seoul, Republic of Korea

    Kyungah Jeong

  6. Department of Obstetrics and Gynecology, Soonchunhyang University Bucheon Hospital, Gyeonggi-do, Republic of Korea

    Tae-Hee Kim

  7. Soonchunhyang University College of Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Republic of Korea

    Yun Sook Kim

  8. Department of Obstetrics and Gynecology, Ulsan University Hospital, Ulsan University College of Medicine, Ulsan, Republic of Korea

    Yong-Soon Kwon

  9. Department of Obstetrics and Gynecology, Eulji University, Nowon Eulji Medical Center, Seoul, Republic of Korea

    Yong-Soon Kwon

  10. Obstetrics and Gynecology, School of Medicine, Keimyung University, Daegu, Republic of Korea

    Chi-Heum Cho

  11. Department of Obstetrics and Gynecology, Kangnam Sacred Heart Hospital, Hallym University, Seoul, Republic of Korea

    Sung Ho Park

  12. Department of Obstetrics and Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

    Sung Hoon Kim

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  1. BaikSeol Cho
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Correspondence to Sung Hoon Kim.

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Cho, B., Roh, JW., Park, J. et al. Safety and Effectiveness of Dienogest (Visanne®) for Treatment of Endometriosis: A Large Prospective Cohort Study. Reprod. Sci. 27, 905–915 (2020). https://doi.org/10.1007/s43032-019-00094-5

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  • DOI: https://doi.org/10.1007/s43032-019-00094-5

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