FE | Risk Minimisation Patient
Product information
Visanne® provides effective reduction of endometriosis-associated pain
Visanne® is indicated for the treatment of endometriosis.1
Treatment with Visanne® is effective in relieving multiple types of endometriosis-related pain and achieving significant reductions in pelvic pain (EAPP), dyspareunia, dysmenorrhea and improvements in quality of life, as demonstrated by studies of up to 60 months.2-10
Sustained pain relief up to 6 months after cessation of Visanne®4
Adapted from Strowitzki T et al. 2010.4
- Dienogest exhibits local biological effects on progesterone-receptor binding, cell proliferation, and inflammation, and significantly reduces endometriotic lesion size2,11-14
- Long-term Visanne® treatment was shown to reduce the post-surgical recurrence of endometriosis and endometriosis-related symptoms for up to 5 years, and treatment with Visanne® also improves post-surgical severity of pain symptoms15-18
DNG – dienogest; EAPP – endometriosis-associated pelvic pain; SEM – standard error of the mean; VAS – visual analog scale
- Visanne® Summary of Product Characteristics. Return to content
- Köhler G, Faustmann TA and Gerlinger C et al. Int J Gynaecol Obstet 2010;108:21–25. Return to content
- Lang J, Yu Q, Zhang S et al. J Womens Health (Larchmt) 2018;27(2):148–155. Return to content
- Strowitzki T, Faustmann T, Gerlinger C et al. Eur J Obstet Gynecol Reprod Biol 2010;151(2):193–198. Return to content
- Strowitzki T, Marr J, Gerlinger C, Faustmann T et al. Hum Reprod 2010;25(3):633–641. Return to content
- Yela DA, Kajikawa P, Donati L et al. J Endometr Pelvic Pain Disord 2015;7(1):33–37. Return to content
- Muzii L, Gakatu G, Di Tucci C et al. Gynecol Endocrinol 2020;36(1):81–83. Return to content
- Del Forno S, Mabrouk M, Arena A et al. Eur J Obstet Gynecol Reprod Biol 2019;238:120–124. Return to content
- RömerT. Arch Gynecol Obstet 2018;298(4):747–753. Return to content
- Caruso S, Iraci M, Cianci S et al. J Pain Res 2019;12:2371–2378. Return to content
- Mita S, Shimizu Y, Notsu T et al. Fertil Steril, 2011;96(6):1485–1489 e4. Return to content
- Mueck AO. Expert Rev Obstet Gynecol 2011;6(1):5–15. Return to content
- Okada H, Nakajima T, Yoshimura T et al. Mol Hum Reprod 2001;7(4):341–7. Return to content
- Sasagawa S, Shimizua Y, Kami H et al. Steroids 2008;73(2):222–231. Return to content
- Adachi K, Takahashi K, Nakamura K et al. Gynecol Endocrinol 2016;32(8):646–649. Return to content
- Lee SR, Yi KW, Song JY et al. Reprod Sci 2018;25(3):341–346. Return to content
- Ota Y, Andou M, Yanail S et al. Journal of Endometriosis and Pelvic Pain Disorders 2015;7(2):63–67. Return to content
- Lee JH, Song JY, Yi KW et al. Reprod Sci 2018;25(10):1515–1522. Return to content
Numerous long-term studies, coupled with robust real-world evidence, confirm Visanne® as an effective treatment for endometriosis
Four observational, post-authorization studies provide real-world evidence for use of Visanne®1,13-17
| Study type | Study duration | Sample size (N) | Location | Main end-point | Publication(s) |
|---|---|---|---|---|---|
| Daily practice treatment and Influence of Visanne® on the patient Assessment of quality of life parameters (DIVA) | 6 months, optional 12 months | ~3000 | 10 countries: Belarus, Egypt, Jordan, Kazakhstan, Kuwait, Lebanon, Qatar, Russia, Saudi Arabia, Ukraine | Quality of life under real-life conditions | Bayer. Available at: https://clinicaltrials.bayer.com/study/1311. Nov 1913 Yarmolinskaya M et al. Poster at SEUD 20161 |
| Visanne® Post-approval Observational Study (VIPOS) | 3–7 years | ~28,000 | 6 European counties: Germany, Poland, Hungary, Switzerland, Russia, Ukraine | Long-term safety (anemia, depression, treatment failure) | Bayer. Available at: https://clinicaltrials.bayer.com/study/20018. Nov 1914 |
| Effectiveness of Visanne® in improving quality of life in AsIan women with Endometriosis (ENVISION) | 2 years | ~900 | 6 Asian countries: Korea, Indonesia, Malaysia, Philippines, Thailand, Singapore | Quality of life Long-term safety | Bayer. Available at: https://clinicaltrials.bayer.com/study/2084. Nov 1915 Techatraisak et al., 201916 |
| Regulatory Post Marketing Surveillance Study in Korea (KOREA PASS) | 6 months, optional 12 months | ~3000 | Korea | Safety and efficacy | Bayer. Available at: https://clinicaltrials.bayer.com/study/2004. Nov 1917 |
- Yarmolinskaya M et al. Poster at SEUD, 12–14 May 2016, Barcelona. Return to content
- Park SY et al. Clin Exp Reprod Med 2016;43:215–220. Return to content
- Petraglia F, Hornung D, Seitz C et al. Arch Gynecol Obstet 2012; 285:167–173. Return to content
- Ota Y, Andou M, Yanail S et al. Journal of Endometriosis and Pelvic Pain Disorders 2015;7(2):63–67. Return to content
- Momoeda M, Harada T, Terakawa N et al. J Obstet Gynaecol Res 2009;35:1069–1076. Return to content
- Sugimoto K, Nagata C, Hayashi H et al. J Obstet Gynaecol Res 2015;41:1921–1926. Return to content
- Roemer T. Poster 1575 at SEUD, 12–14 May 2016, Barcelona. Return to content
- Kitawaki J, Kusuki I, Yamanaka K et al. Eur J Obstet Gynecol Reprod Biol 2011;157:212–216. Return to content
- Takagi H et al. Abstract 0671 at FIGO, 7–12 October 2012, Rome. Return to content
- Kim SH. Poster at SEUD, 25–28 April 2018, Florence. Return to content
- Lee BS. Poster at SEUD, 25–28 April 2018, Florence. Return to content
- Imthurn B. Poster at SEUD, 25–28 April 2018, Florence. Return to content
- Bayer. Available at: https://clinicaltrials.bayer.com/study/1311. [Accessed February 2021] Return to content
- Bayer. Available at: https://clinicaltrials.bayer.com/study/20018. [Accessed February 2021] Return to content
- Bayer. Available at: https://clinicaltrials.bayer.com/study/2084. [Accessed February 2021] Return to content
- Techatraisak K et al. BMC Womens Health 2019;19:68. Return to content
- Bayer. Available at: https://clinicaltrials.bayer.com/study/2004. [Accessed February 2021] Return to content
Long-term treatment with Visanne® (up to 7 years) showed a favorable safety and tolerability profile1
- Treatment-related adverse events were rated mild-to-moderate in most cases (92.5%), usually subsiding within the first 3 months, and with low rates of discontinuation (8.8%)2
- No clinically relevant impact on standard laboratory parameters, including hematology, blood chemistry, lipids and liver enzymes was observed3-7
- Visanne® Summary of Product Characteristics. Return to content
- Petraglia F, Hornung D, Seitz C et al. Arch Gynecol Obstet 2012; 285:167–173. Return to content
- Strowitzki T, Faustmann T, Gerlinger C et al. Int J Womens Health 2015:7:393–401. Return to content
- Bayer. Visanne Post-approval Observational Study (VIPOS). [Accessed February 2021]; Available from: https://clinicaltrials.bayer.com/study/20018. Return to content
- Bayer. Regulatory Post Marketing Surveillance Study in Korea. [Accessed February 2021]; Available from: https://clinicaltrials.bayer.com/study/2004. Return to content
- Bayer. To evaluate effectiveness of Visanne in improving quality of life in Asian women with Endometriosis. Available from: https://clinicaltrials.bayer.com/study/2084. [Accessed February 2021] Return to content
- Bayer. Daily practice treatment and Influence of Visanne on the patient assessment of quality of life. Available from: https://clinicaltrials.bayer.com/study/1311. [Accessed February 2021] Return to content
Visanne® frequently asked questions
Visanne® is indicated for the treatment of endometriosis. Endometriosis is characterized by the development of endometriotic lesions that lead to inflammation, pain, and the formation of scar tissue and adhesions.1 It is widely agreed that pain is the most relevant symptom and the primary reason for women to seek treatment for endometriosis.
The most typical pain symptoms associated with endometriosis, which also assist in reaching a diagnosis,2,3 include:
- Dysmenorrhea
- Premenstrual pain
- Dyspareunia
- Diffuse/chronic pelvic pain
Visanne® provides effective relief of each of these symptoms. This has been demonstrated by separate measurement of these symptoms4-8 and also by an overall assessment of ’endometriosis-associated pelvic pain (EAPP)’ by means of a VAS.5-10
Additional clinical data, as well as preclinical investigations, show that dienogest (which is the active ingredient in Visanne®) also has a direct effect in reducing endometriotic lesions.4,11-13
VAS – visual analog score
- Kennedy S, Bergqvist A, Chapron C et al. Hum Reprod 2005;20(10):2698–2704. Return to content
- Sinaii N, Plumb K, Cotton L et al. Fertil Steril 2008;89(3):538–545. Return to content
- Farquhar C. BMJ (Clinical research ed) 2007;334(7587):249–253. Return to content
- Köhler G, Faustmann TA and Gerlinger C et al. Int J Gynaecol Obstet 2010;108:21–25. Return to content
- Ebert AD, Dong L, Merz M et al. J Pediatr Adolesc Gynecol 2017;30:560–567 Return to content
- Petraglia F, Hornung D, Seitz C et al. Arch Gynecol Obstet 2012; 285:167–173. Return to content
- Strowitzki T, Marr J, Gerlinger C et al. Int J Gynaecol Obstet 2012;117(3):228–233. Return to content
- Lang J, Yu Q, Zhang S et al. J Womens Health (Larchmt) 2018;27(2):148–155. Return to content
- Strowitzki T, Faustmann T, Gerlinger C et al. Eur J Obstet Gynecol Reprod Biol 2010;151(2):193–198. Return to content
- Strowitzki T, Marr J, Gerlinger C, Faustmann T et al. Hum Reprod 2010;25(3):633–641. Return to content
- Moore C, Köhler G and Müller A. Drugs Today 1999;35(SupplC):41–52. Return to content
- Katsuki Y, Takano Y, Futamura Y et al. Eur J Endocrinol 1998;138(2):216–226. Return to content
- Shimizu Y, Takeuchi T, Mita S et al. Mol Hum Reprod 2009;15(10):693–701. Return to content
Visanne® has not been developed as a contraceptive. Nevertheless, based on its mode of action and available data on ovulation there is complete ovulation inhibition at a daily dose of 2 mg.
The vast majority of women suffering from endometriosis are of reproductive age, and therefore many will require contraception. Visanne® has been shown to possess dose-dependent anti-ovulatory activity and suppresses ovulation with highest efficacy at 2 and 3 mg/day.1 In combination with ethinylestradiol (0.03 mg), dienogest 2 mg reliably inhibits ovulation and is an established contraceptive regimen.2
However, no large phase III studies have directly assessed the contraceptive efficacy of dienogest monotherapy using the Pearl Index as the primary efficacy endpoint. Because Visanne® is indicated only for the treatment of endometriosis, and due to this lack of evidence, women taking Visanne® monotherapy as treatment for endometriosis are advised to use non-hormonal contraception (e.g. barrier method) to prevent unwanted pregnancies, which is pointed out in the label.
- Klipping C, Duijkers I, Remmers A et al. J Clin Pharmacol 2012;52(11):1704–13. Return to content
- Foster RH and Wilde MI. Drugs 1998, 56(5):825–833. Return to content
There is no minimum duration of Visanne®
Endometriosis should be viewed as a chronic condition that requires a long-term management plan to address the complex needs of women.1,2 The decision regarding treatment duration lies with the physician. While there is no recommended minimum treatment duration, there is up to 7 years of data and real-world experience with Visanne® and no safety concerns in women.3-6
Real-world treatment with Visanne® for up to 7 years has been associated with generally mild-to-moderate adverse events (consistent with the drug’s established safety profile) with high rates of recovery from these events, and low discontinuation rates suggestive of good tolerability.3-6
- Practice Committee of the American Society for Reproductive Medicine. Fertil Steril 2014;101(4):927–935. Return to content
- NICE: Endometriosis: diagnosis and management. NICE guideline NG73 2017. Return to content
- Bayer. Visanne Post-approval Observational Study (VIPOS). Available from: https://clinicaltrials.bayer.com/study/20018. Accessed February 2021. Return to content
- Bayer. Regulatory Post Marketing Surveillance Study in Korea. Available from: https://clinicaltrials.bayer.com/study/2004. Accessed February 2021. Return to content
- Bayer. To evaluate effectiveness of Visanne in improving quality of life in Asian women with Endometriosis. Available from: https://clinicaltrials.bayer.com/study/2084. Accessed February 2021. Return to content
- Bayer. Daily practice treatment and Influence of Visanne on the patient assessment of quality of life. Available from: https://clinicaltrials.bayer.com/study/1311. Accessed February 2021. Return to content
Recommendations
