Gracial ProdMonograph_cover - epgonline.org

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1. Introduction •Gracial is the first combiphasic oral contraceptive, with an estrogen-dominant phase of seven days, followed by a progestogen-dominant phase of 15 days • The control of irregular bleeding that this regimen offers makes Gracial ideal for women with unacceptable irregular bleeding patterns •Gracial has also been shown to have beneficial effects on mild to moderate acne Benefits of the Pill The introduction of combined oral contraceptives (OCs) in the early sixties made effective and reversible contraception for women available for the first time. The obvious benefits of the Pill – prevention of unwanted pregnancy and consequent reduction in the need for abortion, the possibility of family planning and the realization of sexual liberation – were quickly recognized. Pill users also appreciated the regulation of the menstrual cycle, the decrease in premenstrual complaints and the possibility of timing their menstrual periods. After some initial hesitation, use of the Pill increased rapidly. By 1999, some 90 million women were using an oral contraceptive, and their number is still growing. Although new forms of contraception may be developed in the near future, the Pill is likely to maintain its important position as a contraceptive, and more and more women are likely to become long-term users. Meanwhile, the development of newer OC formulations, with less systemic effects, has made the Pill acceptable for a wider spectrum of women. 1
Introduction Since all the current low-dose OCs containing new-generation progestogens are safe and reliable, more attention can be given to the development of preparations that are ‘fine-tuned’ to fit the individual needs of women. Switchers Reasons for switching OCs Most OC users who start with a low-dose preparation are satisfied with this. However, for certain subgroups (e.g. women with unacceptable irregular bleeding or subjective side effects), the estrogen/progestogen doses of their firstprescribed OC may not be in balance. These women may benefit from switching to an OC preparation which has been especially developed to meet their specific needs. A study from the Netherlands showed that in 1993, 13.6% of all OC users switched from one brand to another, mainly for reasons of acceptability (Figure 1) (Oddens et al 1994). stop use 12.2% starters 9.4% switchers 13.6% Major Reasons: • cycle control • subjective side effects • skin problems • change to lighter pill same brands 64.8% Fig. 1: OC use and major reasons for brand switching in the Netherlands in 1993 2
Page 1 and 2: ® indicates trademark(s) registere
Page 3 and 4: © 2000 N.V. Organon All rights res
Page 5: Contents Page 8. SUMMARY 42 9. REFE
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:
Summary of product characteristics
Page 59 and 60:
Summary of product characteristics
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