Gracial ProdMonograph_cover - epgonline.org

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Acceptability % 0 Nausea Headache Nervousness Depression Breast tenderness -0.5 -1 -1.5 -2 -2.5 -3 -3.5 -4 -4.5 -1.5 -4 -3.3 -1.1 -3.1 Fig. 11: Changes in incidence of subjective side effects after six cycles of Gracial (compared to levels before Pill use) in starters Dieben, Op ten Berg et al 1994 Negligible effect on body weight 5.3 Body weight Body weight was measured every three months in the multicenter study. There was a mean increase in weight of between 0.1 and 0.6 kg above pretreatment weight over 18 cycles. Since almost 20% of the study population were aged under 20 and the actual weight changes were very small, it is probable that they were merely a reflection of normal growth. Therefore, as with other low-dose OCs, the effect of Gracial on body weight is negligible and merely reflects the natural growth in younger women. 5.4 Continuation rate Overall dropout rate due to bleeding irregularities was 2.2%, and 4.3% due to minor side effects. These very low figures illustrate the high acceptability of Gracial. Conclusion The excellent cycle control during Gracial use, together with a low incidence of subjective side effects and negligible effect on body weight, makes Gracial a highly acceptable Pill. It should prove especially suitable for women who experience unacceptable cycle control with any other low-dose OC. 21
6. Gracial and mild to moderate acne •Gracial significantly increases levels of SHBG and reduces free testosterone • These serum changes in SHBG and free testosterone result in a marked reduction in the incidence and severity of acne • The improvement in acne seen with Gracial is comparable to that seen with cyproterone acetate Androgenic skin disorders Occurrence or worsening of androgenic skin disorders is also a reason for brand switching of oral contraceptives, especially in younger women (Oddens et al 1994). This can be a consequence of the androgenicity of the progestogen component. More androgenic OCs may worsen these skin disorders (and even induce them in those previously free of such conditions). One of the underlying factors is an increased total serum testosterone and/or decreased sex hormone binding globulin (SHBG) levels, leading to an increase in free serum testosterone. In general, exogenous estrogens increase SHBG levels. As a consequence, more testosterone can be bound to SHBG, resulting in a decrease of free testosterone in the blood. This decrease of free testosterone in the blood can lead to an improvement in mild to moderate acne. 6.1 Effect on SHBG and testosterone Due to its unique dosage regimen, Gracial is slightly estrogen dominant. In addition, the active progestogen component of Gracial is the most selective of the progestogens used in combined oral contraceptives. This profile suggests that Gracial has beneficial effects on acne. 22
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: Acceptability % of women 35 30 25 2
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

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