Gracial ProdMonograph_cover - epgonline.org

More documents

Recommendations

Info

9. References Archer DF, Timmer CJ, Lammers P. Pharmacokinetics of a triphasic oral contraceptive containing desogestrel and ethinyl estradiol. Fertil Steril 1994; 61: 645–51 Back DJ, Grimmer SFM, Shenoy N, Orme ML’E. Plasma concentrations of 3-ketodesogestrel after oral administration of desogestrel and intravenous administration of 3-ketodesogestrel. Contraception 1987; 35: 619–26 Bergink EW, Hamburger AD, de Jager E, et al. Binding of a contraceptive progestogen Org 2969 and its metabolites to receptor proteins and human sex hormone-binding globulin. J Steroid Biochem 1981; 14: 175–83 Bergink EW, van Meel F, Turpijn EW, et al. Binding of progestagens to receptor proteins in MCF-7 cells. J Steroid Biochem 1983; 19: 1563–70 Bergink W, Assendorp R, Kloosterboer L, Van Lier W, Voortman G, Qvist I. Serum pharmacokinetics of orally administered desogestrel and binding of contraceptive progestogens to sex hormone-binding globulin. Am J Obstet Gynecol 1990; 163: 2132–7 Breiner M, Romalo G, Schweikert H-U. Inhibition of androgen receptor binding by natural and synthetic steroids in cultured human genital skin fibroblasts. Klin Wochenschr 1986; 64: 732–7 Brinton LA. Oral contraceptives and cervical neoplasia. Contraception 1991; 43: 581–95 Castelli WP. Cardiovascular disease in women. Am J Obstet Gynecol 1988; 158: 1553–60 Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormonal contraceptives: collaborative re-analysis of individual data on 53,297 women with breast cancer and 100,239 women without breast cancer from 54 epidemiological studies. Lancet 1996; 347: 1713–27 Cullberg G, Lindtstedt G, Lundberg G, Lundberg PA, Steffensen K. Central and peripheral effects of desogestrel 15–60 µg daily for 21 days in healthy female volunteers. Acta Obstet Gynecol Scand 1982; Suppl 111: 21–8 Dicfalusy E. Mode of action of contraceptive drugs. Am J Obstet Gynecol 1968; 100: 136–63 Dieben TOM, Beek A van, Coelingh Bennink HJT. Multicentre study with a new biphasic oral contraceptive containing ethinylestradiol and desogestrel. Arzneimittelforschung 1991; 41: 996–8 Dieben TOM, Berg MT Op ten, Coelingh Bennink HJT. Cycle control and side effects of a new combiphasic oral contraceptive regimen. Arzneimittelforschung, 1994; 44: 877–9 Dieben TOM, Vromans L et al. The effects of CTR-24, a biphasic oral contraceptive combination, compared to Diane-35 in women with acne. Contraception, 1994; 50: 373–82 Dunn N, White I, Freemantle S, Mann R. The role of prescribing and referral bias in studies of the association between third generation oral contraceptives and increased risk of thromboembolism. Pharmacoepidemiol Drug Saf 1998; 7: 3–14 Dunn et al. Oral contraceptives and myocardial infarction: results of the MICA case study. BMJ 1999; 318: 1579–83 43
References Falsetti L. Acne treatment with a new estroprogestinic biphasic combination containing desogestrel. Acta Eur Fertil 1991; 22: 283–6 Farmer RDT and Preston TD. The risk of venous thromboembolism associated with low oestrogen oral contraceptives. J Obstet Gynaecol 1995; 1: 13–20 Farmer RDT. Safety of modern oral contraceptives. Results of AAH Meditel Study. Lancet 1996; 347: 259 Farmer RDT, Lawrenson RA, Thompson CR, Kennedy JG, Hambleton IR. Population-based study of the risk of venous thromboembolism associated with various oral contraceptives. Lancet 1997; 349: 83–8 Farmer RDT, Todd J-C, Lewis MA, MacRae KD, Williams TJ. The risk of venous thromboembolic disease amongst German women using oral contraceptives: a database study. Contraception 1998; 57: 67–70 Farmer RDT, Lawrenson RA, Todd JC, Williams TJ, MacRae KD et al. A comparison of the risk of venous thromboembolic disease in association with different combined oral contraceptives. 1999, accepted for publication Gerstmann BB, Piper JM, Tomita DK, Ferguson WJ, Stadel BV et al. Oral contraceptive estrogen dose and the risk of deep venous thromboembolic disease. Am J Epidemiol 1991; 133: 32–7 Geurts TBP, Goorissen EM, Sitsen JMA. Summary of drug interactions with oral contraceptives. Carnforth: Parthenon Publishing Group, 1993 Godsland IF and Crook D. Pathogenesis of vascular disease in oral contraceptive users. Br J Cardiol 1996; 3: 204–8 Hammond GL et al. Serum steroid binding protein concentrations, distribution of progestogens, and bioavailability of testosterone during treatment with contraceptives containing desogestrel or levon<strong>org</strong>estrel. Fertility and Sterility 1984; 42: 44–51 Hasenack HG, Bosch AMG, Käär K. Serum levels of 3-ketodesogestrel after oral administration of desogestrel and 3-ketodesogestrel. Contraception 1986; 33: 591–6 Heinemann LAJ, Lewis MA, Assmann A, Gravens L, Guggenmoos-Holzmann I. Could preferential prescribing and referral behaviour of physicians explain the elevated thrombosis risk found to be associated with third generation oral contraceptives Pharmacoepidemiol Drug Saf 1996; 5: 285–94 Heinemann LAJ, Lewis MA, Thorogood M, Spitzer WO, Guggenmoos- Holzmann I, Bruppacher R. Case-control study of oral contraceptives and risk of thromboembolic stroke: results from international study on oral contraceptives and health of young women. Br Med J 1997; 315: 1502–4 Herings RMC, de Boer A, Urquhart H, Leufkens HGM. Non-causal explanations for the increased risk of venous thromboembolism among users of third generation oral contraceptives [abstract]. Pharmacoepidemiol Drug Saf 1996; 5: S88 Hoppen HO, Hammann P. The influence of structural modification on progesterone and androgen binding of norethisterone. Correlation of nuclear magnetic resonance signal. Acta Endocrinol 1987; 115: 406–12 Jamin C and de Mouzon J. Selective prescribing of third generation oral contraceptives (OCs). Contraception 1996; 54: 55–6 Jick H, Jick SS, Gurewich V, Myers MW, Vasilakis C. Risk of idiopathic cardiovascular death and non-fatal venous thromboembolism in women using oral contraceptives with differing progestogen components. Lancet 1995; 346: 1589–93 44
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 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: 8. Summary The most recent area of
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

Gracial ProdMonograph_cover - epgonline.org

Create successful ePaper yourself

Delete template?

Save as template?