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Behandlung der Endometriose - neue Gestagene -

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Präsentation zum Thema: "Behandlung der Endometriose - neue Gestagene -"—  Präsentation transkript:

1 Behandlung der Endometriose - neue Gestagene -
Gülden Halis 1

2 in ihren “besten Jahren” an Endometriose erkrankt
Epidemiologie weltweit … 1 von 10 Frauen leidet an Endometriose während ihrer reproduktiven Phase Rogers et al., Reprod Sci 2009;16:335–346. 1,761,687,000 Frauen weltweit zwischen 15 und 49 Jahren World Bank. Population Projection Tables by Country and Group, 2010. Die meisten von diesen sind noch nicht diagnostiziert und behandelt! Adamson et al., J Endometriosis 2010;2:3–6. 176 million Frauen in ihren “besten Jahren” an Endometriose erkrankt

3 Epidemiologie in Deutschland …
~ 8 million women viele Patientinnen ! chronische Erkrankung ohne kausale Therapie Individualisiertes Therapiemanagement umfassende Therapie-Algorithmen Langzeit-Therapie über Jahre

4 Behandlungziele - abhängig von der Patientin -
Linderung von Schmerz und anderer Symptome Reduktion der Läsionen Erhalt / Wiederherstellung der Fertilität Vermeidung eines Rezidivs Verbesserung der Lebensqualität

5 Behandlungziele - abhängig von der Patientin -
‘Endometriosis should be viewed as a chronic disease that requires a life-long management plan goal of maximising the use of medical treatment & avoiding repeated surgical procedures’ Practice Committee of the American Society for Reproductive Medicine. Fertil Steril 2008.

6 Behandlungs-Optionen
1. Chirurgisch 2. Medikamentös A) NSAID B) Gestagene Levonorgestrel-IUD – off-label C) OC (zyklisch und nonstop) – off-label D) GnRH-agonist 3. Kinderwunsch-Behandlung 4. Komplementäre Behandlung (TCM)

7 Gestagene ... empfohlen und gewinnen an Popularität effektiv
weniger Nebenwirkungen Vercellini et al. Hum Reprod. 2003 Fokus: Effektivität und Tolerabilität Langzeit-Behandlungen

8 Dienogest 2 mg ... Tolerabilität Sicherheit Effektivität
Therapiekosten Eine neue Option in der Behandlung der Endometriose…?

9 Zulassungsstudien für Dienogest 2mg
Main efficacy end-points Comparator/ Blinding Treatment Publication Lesion reduction: rAFS score Open 1, 2, 4 mg/day 24 weeks Köhler et al. (2010) Pain relief: VAS Placebo/ double-blind 2 mg/day 12 weeks Strowitzki et al. (2010) Leuprolide acetate/open 2 mg/day 24 weeks 2 mg/day 53 weeks + 6 month treatment-free follow up Petraglia et al. (2011) (submitted) References Köhler G, Faustmann TA, Gerlinger C, Seitz C, Mueck AO. A dose-ranging study to determine the efficacy and safety of 1, 2 and 4 mg of dienogest daily for endometriosis. Int J Gynaecol Obstet 2010;108:21–25. Strowitzki T, Faustmann T, Gerlinger C, Seitz C. Dienogest in the treatment of endometriosis-associated pelvic pain: a 12-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol 2010 (in press). Strowitzki T, Marr J, Gerlinger C, Faustmann T, Seitz C. Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial. Hum Reprod 2010;25:633–641. Seitz C, Gerlinger C, Faustmann T, Strowitzki T. Safety of dienogest in the long-term treatment of endometriosis: a one-year, open-label, follow-up study. Fertil Steril 2009;92:S107 (abstract). Further information This slide summarises the designs and main efficacy objectives for the four key studies in the Visanne® clinical development programme. Publication details for these four studies are shown in the left-hand column. 9 9

10 Dienogest 2 mg - Schmerzreduktion
60 60 *P<0.0001 50 50 40 40 VAS (mm)* 30 VAS (mm)* * 30 20 20 10 Dienogest 2 mg (n=102) Placebo (n=96) 10 Total population (prior-dienogest 2 mg and prior-placebo groups combined) Reference Seitz C, Gerlinger C, Faustmann T, Strowitzki T. Safety of dienogest in the long-term treatment of endometriosis: a one-year, open-label, follow-up study. Fertil Steril 2009;92:S107 (abstract). Further information A total of 168 women who completed the 12-week, placebo-controlled study (described above) participated in an open-label extension study to investigate Visanne® for up to 53 additional weeks. Together, the placebo-controlled plus open-label study therefore included an overall treatment period of up to 65 weeks [Seitz et al, 2009]. The mean VAS score in this population decreased progressively during the overall treatment period, from 56.9 mm at baseline of the placebo-controlled study, to 34.1 mm at baseline of the extension study (27.9 mm in the Visanne®-treated subgroup and 40.7 mm in the placebo-treated subgroup), to 11.5 mm at the end of the extension study. 4 8 12 4 8 12 16 20 24 28 32 36 40 44 48 52 Weeks of treatment Weeks of treatment * mean ± SEM EAPP, endometriosis-associated pelvic pain, VAS, visual analogue scale. Petraglia F et al. Submitted 2011; Strowitzki T et al. Eur J Obstet Gynecol Reprod Biol. 2010 10 10

11 Schmerzreduktion Dienogest 2 mg so effektiv wie Leuporelin-Acetat
8 12 24 16 20 4 10 50 70 30 60 40 Dienogest 2 mg Leuprolide acetate VAS (mm) mean ± SEM Weeks of treatment Reference Strowitzki T, Marr J, Gerlinger C, Faustmann T, Seitz C. Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial. Hum Reprod 2010;25:633–641. Further information Visanne® was compared against the GnRH agonist, LA (3.75 mg intramuscularly [IM] every 4 weeks), in a 24-week, randomised, phase III, non-inferiority study of 252 women with laparoscopically-confirmed endometriosis [Strowitzki et al, 2010]. A GnRH agonist was chosen as the active comparator because these agents represent a standard medical therapy in the treatment of endometriosis. Visanne® and LA both provided continuous reductions in pelvic pain measured by VAS. By the end of the 24-week study, the reduction in mean VAS score was 47.5 mm with Visanne® and 46.0 mm with LA, representing a between-group difference of –1.5 mm in favour of dienogest (95% confidence interval, –9.26 to 6.25). The non-inferiority of Visanne® relative to LA was therefore demonstrated, based on the prespecified non-inferiority margin of 15 mm (P<0.0001). VAS, visual analogue scale. Strowitzki T et al. Hum Reprod 11 11

12 Effekt von Dienogest 2mg auf Dysmenorrhoe und prämenstrueller Schmerz
100 B 100 Dysmenorrhoe Prämenstrueller Schmerz Dienogest 4 mg Dienogest 2 mg Dienogest 4 mg Dienogest 2 mg 75 75 Women reporting symptoms (%) Women reporting symptoms (%) 50 50 25 25 Reference Köhler G, Faustmann TA, Gerlinger C, Seitz C, Mueck AO. A dose-ranging study to determine the efficacy and safety of 1, 2 and 4 mg of dienogest daily for endometriosis. Int J Gynaecol Obstet 2010;108:21–25. Further information Treatment with dienogest 2 mg and 4 mg was associated with symptom improvements in substantial proportions of women. This slide shows the reduction in the proportion of women reporting dysmenorrhea and premenstrual pain. 6 12 24 6 12 24 Weeks of treatment Weeks of treatment Köhler G et al. Int J Gynaecol Obstet 12

13 Diffuser Unterbauchschmerz
Effekt von Dienogest 2 mg auf Dyspareunie und diffuser Unterbauchschmerz Weeks of treatment Dienogest 4 mg 6 12 24 Women (%) reporting symptoms 25 50 75 100 Dienogest 2 mg Dyspareunie Diffuser Unterbauchschmerz Reference Köhler G, Faustmann TA, Gerlinger C, Seitz C, Mueck AO. A dose-ranging study to determine the efficacy and safety of 1, 2 and 4 mg of dienogest daily for endometriosis. Int J Gynaecol Obstet 2010;108:21–25. Further information In the dose-range study, treatment with dienogest 2 mg (the dose in Visanne®) once daily for 24 weeks was associated with symptom improvements in substantial proportions of women, similar to the improvement associated with dienogest 4 mg. This slide shows the reduction in the proportions of women reporting dyspareunia and diffuse pelvic pain. Köhler G et al. Int J Gynaecol Obstet 13 13 13

14 Reduktion der Endometriose-Läsionen
Week 0 mean rAFS score* Dienogest 4 mg Dienogest 2 mg 15 10 5 Week 24 * P≤0.0003 Reference Köhler G, Faustmann TA, Gerlinger C, Seitz C, Mueck AO. A dose-ranging study to determine the efficacy and safety of 1, 2 and 4 mg of dienogest daily for endometriosis. Int J Gynaecol Obstet 2010;108:21–25. Further information Changes in rAFS score and in stage of endometriosis at laparoscopy were assessed in the 24-week, dose-range study of dienogest [Köhler et al, 2010]. Dienogest at 2 mg and 4 mg daily produced significant reductions in the rAFS score between baseline and study end. Mean rAFS scores decreased from 11.4 to 3.6 (P=0.0003) in the 2 mg group and from 9.7 to 3.9 (P<0.0001) in the 4 mg group. * mean ± SEM. rAFS, revised American Fertility Society. Köhler G et al. Int J Gynaecol Obstet 14 14

15 Sicherheit und Tolerabilität des Dienogest 2 mg
Sicherheit and Tolerabilität: Endpunkte im klinischen Entwicklungs-Programm beinhalteten: Hypoestrogene Effekte, inkl. Hitzewalungen und Effekte auf die Knochendichte Metabolische Effekte Gewicht Blutungsstörungen Recent key studies on the Visanne® clinical development programme have included a range of safety and tolerability end-points, which in part reflect the known profile for agents in the progestin class. 15 15

16 Relevanteste Unerwünschte Wirkungen
Blutungsstörungen Kopfschmerzen, Brustspannen, Stimmungsschwankungen References Analyses based on pooled data from: Köhler G, Faustmann TA, Gerlinger C, Seitz C, Mueck AO. A dose-ranging study to determine the efficacy and safety of 1, 2 and 4 mg of dienogest daily for endometriosis. Int J Gynaecol Obstet 2010;108:21–25. Strowitzki T, Faustmann T, Gerlinger C, Seitz C. Dienogest in the treatment of endometriosis-associated pelvic pain: a 12-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol 2010 (in press). Strowitzki T, Marr J, Gerlinger C, Faustmann T, Seitz C. Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial. Hum Reprod 2010;25:633–641. Seitz C, Gerlinger C, Faustmann T, Strowitzki T. Safety of dienogest in the long-term treatment of endometriosis: a one-year, open-label, follow-up study. Fertil Steril 2009;92:S107(abstract). Further information Analysis of pooled data that include 332 women from four key studies (i.e. the dose-range, placebo-controlled, active comparator-controlled and long-term extension studies) indicates that the most common adverse events associated with DNG 2mg® are headache (9.0%), breast discomfort (5.4%), depressed mood (5.1%) and acne (5.1%). Adverse events (AEs) are generally mild to moderate in intensity and associated with low rates of treatment discontinuation. A total of 18 AEs in 15 (4.5%) Visanne®-treated patients led to the premature discontinuation of the study medication. AEs leading to discontinuation in >1 patient were: depression (n=3 patients, 0.9%), breast pain (n=2, 0.6%) and ovarian cyst (n=2, 0.6%). The type, frequency and severity of AEs appears to be acceptable in light of the improvement in symptoms of endometriosis during Visanne® treatment. 16 16

17 Östradiol-Level Dienogest 2 mg versus Leuporelinacetat
Estradiol level (pg/mL) mean ± SEM Dienogest 2 mg Leuprolide acetate 10 30 20 50 40 70 60 80 90 100 Weeks of treatment 24 Reference Strowitzki T, Marr J, Gerlinger C, Faustmann T, Seitz C. Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial. Hum Reprod 2010;25:633–641. Further information In the active comparator-controlled study of dienogest versus LA, mean levels of serum estradiol were only moderately suppressed in the dienogest subgroup (n=32; from to pmol/l) but showed a pronounced decrease in the LA subgroup (n=38; from to 68.5 pmol/l) *mean ± SEM Strowitzki T et al. Hum Reprod 17 17

18 % change in bone mineral density (mean ± SEM)
Knochendichte Dienogest 2 mg versus Leuporelinacetat Dienogest 2 mg 2 Leuprolide acetate 1 -1 % change in bone mineral density (mean ± SEM) -2 -3 -4 *P=0.0003 References Strowitzki T, Marr J, Gerlinger C, Faustmann T, Seitz C. Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial. Hum Reprod 2010;25:633–641. Further information A reduction in mean BMD during LA therapy led to a significant divergence from the Visanne® group in the 24-week comparator study [Strowitzki et al]. In women whose measurements were available at both screening and final visit, mean lumbar BMD increased by g/cm² in the Visanne® subgroup (n=21) and decreased by g/cm² in the LA subgroup (n=29), representing mean (± SD) percentage changes of (± 2.77) and –4.04 (± 4.84) for Visanne® and LA, respectively (P= for superiority of Visanne®). -5 Weeks of treatment 24 -6 24 Weeks Strowitzki T et al. Hum Reprod 18 18

19 Dienogest 2 mg – Lipidstoffwechsel
Parameter (normal reference range) Dienogest 2 mg Placebo Baseline Study end Triglycerides; mmol/L (0.8–1.94) 0.96  0.51 1.11  0.68 0.99  0.73 1.08  0.86 Total cholesterol; mmol/L (4.14–6.73) 4.79  0.95 4.87  1.03 4.94  1.12 4.95  1.11 HDL-C; mmol/L (1.09–2.28) 1.48  0.31 1.48  0.34 1.55  0.38 1.55  0.33 LDL-C; mmol/L (1.97–5.65) 2.89  0.73 2.93  0.77 2.95  0.75 2.95  0.76 Reference Strowitzki T, Faustmann T, Gerlinger C, Seitz C. Dienogest in the treatment of endometriosis-associated pelvic pain: a 12-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol 2010 (in press). Further information The placebo-controlled study in the Visanne® clinical development programme included measurements of lipid parameters. This study revealed a lack of a relevant effect of Visanne® on lipid levels, which is predicted from preclinical studies of the pharmacological profile of dienogest. For example, mean (SD) total cholesterol levels increased by 0.10  0.93 mmol/L in the dienogest group and decreased by 0.01  0.87 mmol/L in the placebo group, while mean triglyceride levels increased by 0.14  0.53 mmol/L and 0.07  0.48 mmol/L, respectively. Mean (± SD) lipid concentrations at baseline and after 12 weeks of dienogest 2 mg or placebo treatment. SD, standard deviation; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol. Strowitzki T et al. Eur J Obstet Gynecol Reprod Biol 19 19

20 Dienogest 2 mg - Körpergewicht
Gepoolte Analyse des Körpergewichts Daten aus klinschem Entwicklungsprogramm Placebo Dienogest 2 mg Leuprolide acetate Change from baseline in kg (mean±SD) Weeks of treatment -3 -2 -4 1 -1 3 4 2 5 6 Week 12 Week 24 Week 52 References Strowitzki T, Faustmann T, Gerlinger C, Seitz C. Dienogest in the treatment of endometriosis-associated pelvic pain: a 12-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol 2010 (in press). Strowitzki T, Marr J, Gerlinger C, Faustmann T, Seitz C. Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial. Hum Reprod 2010;25:633–641. Seitz C, Gerlinger C, Faustmann T, Strowitzki T. Safety of dienogest in the long-term treatment of endometriosis: a one-year, open-label, follow-up study. Fertil Steril 2009;92:S107 (abstract). Further information An increase in body weight is a common effect of therapy with a number of agents in the progestin class; however, Visanne® is not associated with clinically relevant changes in body weight, based on individual studies [Strowitzki et al, 2010; Strowitzki et al, 2010; Seitz et al, 2009] and analyses of pooled data. Pooled data for patients treated with Visanne® or placebo for 12 weeks (SD) indicated mean increases of 0.3 and 0.4 kg, respectively. In the 24-week LA comparator study, changes in body weight were similar for Visanne® and LA, at kg and kg, respectively [Strowitzki et al, 2010]. The long-term extension study showed little alteration in body weight over 1 year of dienogest treatment. In patients who had body weight assessments at both baseline and after 1 year of treatment, the mean change in body weight was kg [Seitz et al, 2009]. 1. Strowitzki T et al. Eur J Obstet Gynecol Reprod Biol. 2010; 2. Strowitzki T et al. Hum Reprod. 2010; 3. Petraglia F et al. Submitted 2011. 20 20

21 Dienogest 2 mg - Blutungsstörung
30 Dienogest 2 mg 25 20 Cumulative number of bleeding/spotting days per 3-month period 15 10 5 Reference Seitz C, Gerlinger C, Faustmann T, Strowitzki T. Safety of dienogest in the long-term treatment of endometriosis: a one-year, open-label, follow-up study. Fertil Steril 2009;92:S107 (abstract). Further information Continued dienogest treatment during the extension study was associated with a progressive reduction in the mean number of bleeding/spotting days (see slide), number of bleeding/spotting episodes, and duration of bleeding/spotting episodes between 90-day reference periods. Subgroup analysis during the extension study showed that both the prior-dienogest and the prior-placebo subgroups of the placebo-controlled study experienced decreases in the number of bleeding/spotting days, number of spotting episodes, and duration of bleeding/spotting episodes. These decreases were greater in the prior-placebo group than in the prior-dienogest group. By 90-day reference period 4, there were no differences in bleeding parameters between the two groups. Between 90-day reference periods 1 and 4, a substantial increase in “amenorrhea” (from 7.9% to 25.0% of women) and a decrease in heavy bleeding (from 9.8% to 2.2%) was shown. 1-3 4-6 7-9 10-12 Months Petraglia F et al. Submitted 2011.

22 Treatment period* Month 1‒3 (n=290)
Dienogest 2 mg - Blutungsstörung Pooled analysis of bleeding pattern data from dienogest 2 mg clinical study programme Bleeding and spotting Treatment period* Month 1‒3 (n=290) Treatment period* Month 9‒12 (n=149) Amenorrhea 2% 28% Infrequent 27% 24% Irregular 35% 22% Frequent 13% 3% Prolonged 38% 4% Normal (none of the above) 20% 23% References Strowitzki T, Faustmann T, Gerlinger C, Seitz C. Dienogest in the treatment of endometriosis-associated pelvic pain: a 12-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol 2010 (in press). Strowitzki T, Marr J, Gerlinger C, Faustmann T, Seitz C. Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial. Hum Reprod 2010;25:633–641. Seitz C, Gerlinger C, Faustmann T, Strowitzki T. Safety of dienogest in the long-term treatment of endometriosis: a one-year, open-label, follow-up study. Fertil Steril 2009;92:S107 (abstract). Gerlinger C, Endrikat J, Kallischnigg G, Wessel J. Evaluation of menstrual bleeding patterns: a new proposal for a universal guideline based on the analysis of more than 4500 bleeding diaries. Eur J Contracept Reprod Health Care 2007;12:203–211. Further information Irregular uterine bleeding is a known adverse effect of treatment with progestins. The menstrual bleeding pattern associated with Visanne® has been assessed systematically in a pooled analysis of data from the clinical development programme [Strowitzki et al, 2010; Strowitzki et al, 2010; Seitz et al, 2009], using the method published by Gerlinger et al, By this method, bleeding patterns are analysed in reference periods of 90 days’ duration, in accordance with recommendations by the World Health Organization. Analyses of the proportions of women with clinically important bleeding patterns, summarised in this slide, demonstrate that the intensity of bleeding improves with continued Visanne® treatment. Niedrige drop-out-Raten trotz Blutungsstörung Distributions of women with each menstrual bleeding pattern during dienogest 2 mg treatment* *Numbers add up to more than 100% because each patient could fall into more than one category. 1. Strowitzki T et al. Eur J Obstet Gynecol Reprod Biol. 2010; 2. Strowitzki T et al. Hum Reprod. 2010; 3. Seitz C et al. Fertil Steril 22 22

23 Dienogest 2mg - Zusammenfassung (1)
Effektiv in der Therapie bei Dysmenorrhoe Premenstruellen Schmerzen Dyspareunie Diffusen Unterbauchschmerzen Hierbei Schmerz-Reduktion auch bei Langzeit-Therapie Signifikant dem Placebo überlegen Equivalent zu GnRH-agonist Verbesserung der Lebensqualität This and the next slide aim to summarise the quality of evidence that is available from the Visanne® clinical development programme in endometriosis. Visanne® is the only oral progestin that has been systematically investigated exclusively for the treatment of endometriosis through a dedicated study programme that included dose-range, placebo-controlled, active comparator-controlled and long-term studies. This trial programme demonstrates that Visanne® is a highly effective therapy for reducing the painful symptoms of endometriosis, with an efficacy significantly superior to placebo and equivalent to current standard therapy with GnRH agonists, such as leuprolide acetate and buserelin. Clinical evidence extending up to 15 months shows that Visanne® provides sustained pain relief. Visanne® also effectively reduces endometriotic lesions, measured at laparoscopy. 23 23

24 Dienogest 2mg - Zusammenfassung (2)
Häufigste unerwünschte Wirkungen Blutungsstörungen (50% in ersten 6 Monaten) Kopfschmerzen (9.0%) Brustspannen (5.4%) Stimmungsschwankungen (5.1%) Jedoch: Niedrige dropout-Raten Nebenwirkungsprofil akzeptabel bei deutlicher Symptomverbesserung

25 Danke Dr. Gülden Halis www.fertilitaet.de
Zertifiziertes Stufe II – Endometriosezentrum Kinderwunsch Endometriose Endokrinologie Deck 4 of the ‘Visanne® (Dienogest) in Endometriosis scientific slide set’ describes in greater detail the key individual studies from the Visanne® clinical study programme – including their designs, objectives, outcomes and conclusions. Dr. Gülden Halis 25 25 25 25

26 Danke Dr. Gülden Halis www.fertilitaet.de
Zertifiziertes Stufe II – Endometriosezentrum Kinderwunsch Endometriose Endokrinologie Deck 4 of the ‘Visanne® (Dienogest) in Endometriosis scientific slide set’ describes in greater detail the key individual studies from the Visanne® clinical study programme – including their designs, objectives, outcomes and conclusions. Dr. Gülden Halis 26 26 26 26

27 Endpunkte in der Prüfung der Effektivität im klinischen Entwicklungsprogramm
Reduktion von Schmerz und anderen Symptomen Visuelle Analog-Skala Biberoglu - Behrman Score Reduktion der Endometriose-Läsionen Revised American Fertility Society/American Society for Reproductive Medicine score References Mahutte NG, Arici A. Medical management of endometriosis-associated pain. Obstet Gynecol Clin North Am 2003;30:133–150. Sinaii N, Cleary SD, Younes N et al. Treatment utilization for endometriosis symptoms: a cross-sectional survey study of lifetime experience. Fertil Steril 2007;87:1277–1286. Somigliana E, Vigano P, Barbara G et al. Treatment of endometriosis-related pain: options and outcomes. Front Biosci 2009;1:455–465. Revised American Society for Reproductive Medicine classification of endometriosis: Fertil Steril 1997;67:817–821. Further information Pain relief is the most relevant outcome for the symptomatic patient seeking treatment for endometriosis and should be a measure of success for any medication [Mahutte & Arici 2003; Sinaii et al, 2007; Somigliana et al, 2009]. Recent studies of Visanne® which included symptom assessments as an efficacy measure included visual analogue scale and Biberoglu and Behrman scores. Assessment of lesion reduction by laparoscopy provides additional evidence for the efficacy of Visanne® in endometriosis. Although pain relief is now established as the primary efficacy measure in endometriosis studies, and the correlation between pain relief and lesion reduction is not robust, the availability of laparoscopic data is important in demonstrating that Visanne® addresses the underlying pathology, in addition to the most important clinical symptoms of endometriosis. Laparoscopic measures of endometriosis frequently use the revised American Society for Reproductive Medicine (rASRM) (previously called the American Fertility Society, rAFS) scoring system. 27 27 27

28 Visuelle Analog-Skala
Unterbauchschmerzen 0 mm 100 mm Keine Schmerzen Vernichtender Schmerz Schmerz der Patientinnen vor Therapie bei 60mm Reference Olive DL. Endometriosis in Clinical Practice. Taylor & Francis, 2005. Further information The visual analogue scale (VAS) is a validated tool for assessing the level of pain and is widely used in clinical trials, including endometriosis studies. The VAS commonly uses a scale of 1 to 100 mm, where 0 mm represents no pain and 100 m indicates the worst pain imaginable. Standardisation of tools such as the VAS across clinical trials facilitates comparison of study outcomes. 28 28 28


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