Gracial ProdMonograph_cover - epgonline.org

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Gracial and mild to moderate acne Number and severity of acne lesions reduced Recently, the effects of Gracial on acne were again compared with those of an OC preparation containing ethinylestradiol and cyproterone acetate (2.0 mg cyproterone acetate/35 µg EE) (Melief 2000). The study (in which 172 women were randomized to either treatment) found that Gracial progressively reduced the number and severity of acne lesions during the six cycles of treatment. In both groups, the majority of women with severe acne shifted to a less severe acne category (Figure 14). The efficacy of Gracial was comparable to the preparation containing the antiandrogen cyproterone acetate and no statistically significant differences were observed between the two groups. % 100 90 80 70 60 50 40 30 20 10 0 % 100 90 80 70 60 50 40 30 20 10 0 A 0 3 6 0 3 6 Combiphasic EE/DSG EE35/CPA B 0 3 6 0 3 6 Combiphasic EE/DSG EE35/CPA Severe Moderate Mild No acne Fig. 14: Objective (A) and subjective (B) classification of severity of acne at pretreatment, Cycle 3 and Cycle 6 25 Melief 2000
Gracial and mild to moderate acne Reduction in severity of acne Another recent noncomparative clinical evaluation of women who switched from a different OC to Gracial showed a reduction in the severity of acne during treatment with Gracial (Figure 15) (Vree 2000). 100 80 52% % of women 60 40 35% 77% 20 18% 0 Previous OC (n=592) No. of papules/pustules: Gracial (n=396) 1–5 6–10 >10 Fig. 15: Changes in acne severity after switching to Gracial Vree 2000 Conclusion Gracial significantly increases SHBG levels and reduces free testosterone, which results in an improvement in the incidence and severity of mild to moderate acne comparable to that of cyproterone acetate. 26
Page 1 and 2: ® indicates trademark(s) registere
Page 3 and 4: © 2000 N.V. Organon All rights res
Page 5 and 6: Contents Page 8. SUMMARY 42 9. REFE
Page 7 and 8: Introduction Since all the current
Page 9 and 10: Introduction 1.1 Rationale for Grac
Page 11 and 12: 2. Pharmacokinetics • After oral
Page 13 and 14: Pharmacokinetics ENG mainly bound t
Page 15 and 16: 3. Pharmacodynamics •Etonogestrel
Page 17 and 18: Pharmacodynamics 40 30 20 10 0 nore
Page 19 and 20: Pharmacodynamics mIU/ml 7 6 5 4 3 2
Page 21 and 22: 4. Contraceptive efficacy • The P
Page 23 and 24: Acceptability Effect of Gracial on
Page 25 and 26: Acceptability % of women 35 30 25 2
Page 27 and 28: 6. Gracial and mild to moderate acn
Page 29: Gracial and mild to moderate acne G
Page 33 and 34: Safety aspects Gracial not included
Page 35 and 36: Safety aspects The incidence of VTE
Page 37 and 38: Safety aspects Table 5: Relative ri
Page 39 and 40: Safety aspects Oral contraceptives
Page 41 and 42: Safety aspects Stroke With regard t
Page 43 and 44: Safety aspects Influence of adjustm
Page 45 and 46: Safety aspects On balance, this stu
Page 47 and 48: 8. Summary The most recent area of
Page 49 and 50: References Falsetti L. Acne treatme
Page 51 and 52: References Lunsen HW van. Recent or
Page 53 and 54: 10. Summary of product characterist
Page 55 and 56: Summary of product characteristics

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