Gracial ProdMonograph_cover - epgonline.org

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Contents Page 1. INTRODUCTION 1 1.1 Rationale for <strong>Gracial</strong> 4 2. PHARMACOKINETICS 6 2.1 Desogestrel 6 Absorption 6 Metabolism 6 Distribution 7 Elimination 7 2.2 Ethinylestradiol 8 3. PHARMACODYNAMICS 10 3.1 Receptor affinity 10 3.2 Selectivity index 11 3.3 Effects on the pituitary ovarian axis 12 3.4 Effects on cervical mucus 15 4. CONTRACEPTIVE EFFICACY 16 5. ACCEPTABILITY 17 5.1 Cycle control 17 Irregular bleeding 18 Withdrawal bleeding 18 5.2 Side effects 20 5.3 Body weight 21 5.4 Continuation rate 21 6. GRACIAL AND MILD TO MODERATE ACNE 22 6.1 Effect on SHBG and testosterone 22 6.2 Clinical effects 23 7. SAFETY ASPECTS 27 7.1 Venous thromboembolism 28 Hemostasis 28 Epidemiological data 29 7.2 Arterial disease 33 Lipid metabolism 33 Carbohydrate metabolism 35 Blood pressure 35 Epidemiological data 35 7.3 Gynecological cancer 38 Breast cancer 39 Cervical, ovarian and endometrial cancer 40
Contents Page 8. SUMMARY 42 9. REFERENCES 43 10. SUMMARY OF PRODUCT CHARACTERISTICS 48
Page 1 and 2: ® indicates trademark(s) registere
Page 3: © 2000 N.V. Organon All rights res
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 and 30: Gracial and mild to moderate acne G
Page 31 and 32: Gracial and mild to moderate acne R
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
Page 57 and 58:
Page 59 and 60:
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