Clinical findings with the dienogest-containing oral contraceptive Valette®

Drugs of Today

Volumn 35, Issue SUPPL. C, 1999, Pages 53-68

  Moore, Claudia ^a   Feichtinger, W ^b   Klinger, G ^c   Mellinger, U ^a   Spona, J ^e   Walter, F ^a   Winkler, U H ^e   Zahradnik, H P ^d  

^a BAYER PHARMA AG   (Germany)

^b Institute for Sterility Treatment   (Austria)

^c FRIEDRICH SCHILLER UNIVERSITY JENA   (Germany)

^d UNIVERSITY OF FREIBURG   (Germany)

^e NONE

Author keywords

[No Author keywords available]

Indexed keywords

APOLIPOPROTEIN A1; APOLIPOPROTEIN B; DIENOGEST; DIENOGEST PLUS ETHINYLESTRADIOL; ETHINYLESTRADIOL; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; ORAL CONTRACEPTIVE AGENT; TRIACYLGLYCEROL; UNCLASSIFIED DRUG;

ADULT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; HEADACHE; HEMOSTASIS; HUMAN; HUMAN EXPERIMENT; HYPERINSULINEMIA; LIPID METABOLISM; MASTALGIA; MENSTRUAL IRREGULARITY; MULTICENTER STUDY; NAUSEA; ORAL CONTRACEPTION; ORAL DRUG ADMINISTRATION; OVULATION INHIBITION; RANDOMIZED CONTROLLED TRIAL; REVIEW; VERTIGO;

EID: 0032806866     PISSN: 16993993     EISSN: 16994019     Source Type: Journal    
DOI: None     Document Type: Review

References (62)

1. Committee on Safety of Drugs. Combined oral contraceptives. A statement by the Committee on Safety of Drugs. Br Med J 1970, 1: 231-2.
2. Jeffcoat, T.N.A. RCOG Statement on oral contraceptives. Br Med J 1970, 1: 293.
3. Winkler, U.H., Koslowski, S., Schindler, A.E. PAI activity is reduced in users of oral contraceptives-influence of estrogen content. Thromb Haemost 1989, 62: 394.
4. Bottiger, L.E., Boman, G., Eklund, G., Westerholme, B. Oral contraceptives and thromboembolic disease: Effects of lowering oestrogen content. Lancet 1980, i: 1097-101.
5. Meade, T.W. Oral contraceptives, clotting factors and thrombosis. Am J Obstet Gynecol 1982, 142: 758-61.
6. Sabra, A., Bonnar, J. Haemostatic system changes induced by 50 μg and 30 μg oestrogen/progestin oral contraceptives. Modification of oestrogen effects by levonorgestrel. J Reprod Med 1983, Suppl 28: 85-91.
7. Daly, L., Bonnar, J. Comparative studies of 30 μg ethinylestradiol combined with gestodene and desogestrel on blood coagulation, fibrinolysis, and platelets. Am J Obstet Gynecol 1990, 163: 430-7.
8. Bonnar, J., Daly, L., Carroll, E. Blood coagulation with a combination pill containing gestodene and ethinylestradiol. Int J Fertil 1987, Suppl 32: 21-8.
9. Bonnar, J. Coagulation effects of oral contraception. Am J Obstet Gynecol 1987, 157: 1042-8.
10. Oettel, M., Carol, W., Elger, W. et al. A 19-norprogestin without a 17α-ethinyl group. II: Dienogest from a pharmacodynamic point of view. Drugs of Today 1995, 31: 517-36.
11. Kuhl, H. Ovulationshemmer: Die Bedeutung der Östrogendosis. Geburtsh Frauenheilk 1992, 50: 910-22.
12. Kuhl, H. Aktuelle Entwicklungen in der hormonalen Kontrazeption. Gynäkologe 1992, 25: 1-240.
13. Goldzieher, J.W., de la Pena, A., Chenault, C.B., Woutersz, T.B. Comparative studies of the ethynyl estrogens used in oral contraceptives. Am J Obstet Gynecol 1975, 122: 619-24.
14. Jackson, J.L., Soain, W.T., Payne, H. The antiovulatory dose of ethinylestradiol. A titration study. Fertil Steril 1968, 19: 649-53.
15. Kuhl, H. Comparative pharmacology of newer progestins. Drugs 1996, 51: 188-215.
16. Kuhl, H., Jung-Hoffmann, C., Storch, A., Fitzner, M., Rühl, E. New aspects on the mechanism of action of contraceptive steroids - recent pharmacokinetic studies of low dose formulations. Adv Contracept 1991, Suppl 3: 149-63.
17. Moore, C., Walter, F., Klinger, G., Carol, W. Der Einfluß von Dienogest auf die Ovulation junger Frauen und auf ausgewählte endokrinologische Parameter. In: Dienogest - Präklinik und Klinik eines neuen Gestagens. Teichmann, A.T. (Ed.). Walter de Gruyter Verlag: Berlin 1995, 161-9.
18. Schleussner, E., Michels, W., Bethge, S. et al. Die Wirkung von Dienogest auf die hypothalamisch-hypophysäre Achse: Ergebnisse einer Pilotstudie. In: Dienogest - Präklinik und Klinik eines neuen Gestagens. Teichmann, A.T. (Ed.). Walter de Gruyter Verlag: Berlin 1995, 171-9.
19. Fern, M., Rose, D.P., Fern, E.B. Effect of oral contraceptives on plasma androgenic steroids and their precursors. Obstet Gynecol 1978, 51: 541-4.
20. Kuhl, H., Jung-Hoffmann, C., Fitzner, M. Prodrug versus drug effects of 150 μg desogestrel or 3-keto-desogestrel in combination with 30 μg ethinylestradiol on hormonal parameters: Relevance of the peak serum level of 3-keto-desogestrel. Horm Res 1995, 44: 126-32.
21. Commission of the European Community. Clinical Investigation of Oral Contraceptives. January, 1989.
22. Spona, J., Feichtinger, W., Kindermann, C., et al. Modulation of ovarian function by an oral contraceptive containing 30 μg ethinyl estradiol in combination with 2.00 mg dienogest. Contraception 1997, 56: 185-91.
23. Speroff, L., DeCherney, A. Advisory board for the new progestins. Evaluation of a new generation of oral contraceptives. Obstet Gynecol 1993, 81: 1034-47.
24. Trussell, J., Hatcher, R.A., Cates, W., Stewart, F.H., Kost, K. A guide to interpreting contraceptive efficacy studies. Obstet Gynecol 1990, 76: 558-67.
25. Brill, K., Norpoth, T., Schnitker, J., Albring, M. Clinical experience with a modern low-dose oral contraceptive in almost 100,000 users. Contraception 1991, 43: 101-10.
26. Corson, S.L. Contraceptive efficacy of a monophasic oral contraceptive containing desogestrel. Am J Obstet Gynecol 1993, 168: 1017-20.
27. Harrison, D.P. Contact lens wear problems: Implications of penicillin allergy, diabetic relatives, and use of birth control pills. Am J Optometr Physiol Optics 1984, 61: 674-8.
28. Düsterberg, B., Brill, K. Clinical acceptability of monophasic gestodene. Am J Obstet Gynecol 1990, 163: 1398-404.
29. Garza-Flores, J., Valles de Bourges, V., Martinez, M. et al. Safety and efficacy of a combined oral contraceptive: Gestodene 75 μg plus ethinylestradiol 30 μg in Mexican women. Adv Contracept 1994, 10: 19-26.
30. Rekers, H. Multicenter trial of a monophasic oral contraceptive containing ethinyl estradiol and desogestrel. Acta Obstet Gynecol Scand 1988, 67: 171-4.
31. Aznar-Ramos, R., Giner-Velasquez, J., Lara-Ricalde, R., Martínez-Manautou, J. Incidence of side-effects with contraceptive placebo. Am J Obstet Gynecol 1969, 105: 1144-9.
32. Goldzieher, J.W., Moses, L.E., Averkin, E., Scheel, C., Taber, B.Z. A placebo-controlled double-blind crossover investigation of the side effects attributed to oral contraceptives. Fertil Steril 1971, 22: 609-23.
33. Kirkman, R.J.E., Pedersen, J.H., Fioretti, P., Roberts, H.E. Clinical comparison of two low-dose oral contraceptives, Minulet and Mercilon, in women over 30 years of age. Contraception 1994, 49: 33-46.
34. Latin American Oral Contraceptive Study Group. Clinical comparison of monophasic oral contraceptive preparations of gestodene/ethinylestradiol and desogestrel/ethinylestradiol. Contraception 1994, 50: 201-14.
35. Loudon, N.B., Kirkman, R.J.E., Dewsbury, J.A. A double-blind comparison of the efficacy and acceptability of femodene and microgynon-30. Eur J Obstet Gynecol Reprod Biol 1990, 34: 257-66.
36. Rosenberg, M.J., Waugh, M.S., Higgins, J.E. The effect of desogestrel, gestodene, and other factors on spotting and bleeding. Contraception 1996, 53: 85-90.
37. Jung-Hoffmann, C., Heidt, F., Kuhl, H. Effect of two oral contraceptives containing 30 μg ethinylestradiol and 75 μg gestodene or 150 μg desogestrel upon various hormonal parameters. Contraception 1988, 38: 593-603.
38. Fuchs, N., Düsterberg, B., Weber-Diehl, F., Mühe, B. The effect on blood pressure of a monophasic oral contraceptive containing ethinylestradiol and gestodene. Contraception 1995, 51: 335-9.
39. Kovacs, L., Bartfai, G., Apro, G. et al. The effect of the contraceptive pill on blood pressure: A randomized controlled trial of three progestin-oestrogen combinations in Szeged, Hungary. Contraception 1986, 33: 69-77.
40. Kuhl, H., Gahn, G., Romberg, G., Althoff, P.H., Taubert, H.D. A randomized crossover comparison of two low-dose oral contraceptives upon hormonal and metabolic serum parameters: II. Effects upon thyroid function, gastrin, STH, and glucose tolerance. Contraception 1985, 32: 97-107.
41. Kuhl, H., Jung-Hoffmann, C., Weber, J., Boehm, B.O. The effect of a biphasic desogestrel-containing oral contraceptive on carbohydrate metabolism and various hormonal parameters. Contraception 1993, 47: 55-68.
42. Kuhl, H., Jung-Hoffmann, C., Wiegratz, I. Gestodene-containing contraceptives. Clin Obstet Gynecol 1995, 38: 829-40.
43. Crook, D., Godsland, I.F., Wynn, V. Oral contraceptives and coronary heart disease: Modulation of glucose tolerance and plasma lipid risk factors by progestins. Am J Obstet Gynecol 1988, 158: 1612-20.
44. Godsland, I.F., Crook, D., Simpson, R., et al. The effect of different formulations of oral contraceptive agents on lipid and carbohydrate metabolism. N Engl J Med 1990, 323: 1375-81.
45. Jandrain, B.J., Humblet, D.M.P., Jaminet, C.B., Scheen, A.J., Gaspard, U.J., Lefebvre, P.J. Effects of ethinyl-estradiol combined with desogestrel and cyproterone acetate on glucose tolerance and insulin response to an oral glucose load: A one-year randomized, prospective, comparative trial. Am J Obstet Gynecol 1990, 163: 378-81.
46. Kuhl, H., März, W., Jung-Hoffmann, C., Heidt, F., Gross, W. Time-dependent alterations in lipid metabolism during treatment with low-dose oral contraceptives. Am J Obstet Gynecol 1990, 163: 363-9.
47. März, W., Jung-Hoffmann, C., Heidt, F., Gross, W., Kuhl, H. Changes in lipid metabolism during 12 months of treatment with two oral contraceptives containing 30 μg ethinylestradiol and 75 μg gestodene or 150 μg desogestrel. Contraception 1990, 41: 245-58.
48. Bloemenkamp, K.W.M., Rosendaal, F.R., Helmerhorst, F.M., Büller, H.R., Vandenbroucke, J.P. Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestagen. Lancet 1995, 346: 1593-96.
49. Jick, H., Jick, S.S., Gurewich, V., Myeres, M.W., Vasilakis, C. Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components. Lancet 1995, 346: 1589-93.
50. Spitzer, W.O., Lewis, M.A., Heinemann, L.A.J., Thorogood, M., MacRae, K.D. Third generation oral contraceptives and risk of venous thromboembolic disorders: An international case-control study. Br Med J 1996, 312: 83-8.
51. World Health Organisation Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Effect of different progestagens in low oestrogen and contraceptives on venous thromboembolic disease. Lancet 1995, 346: 1582-8.
52. Farmer, R.D.T., Lawrenson, R.A., Thompson, C.R., Kennedy, J.G., Hambleton, I.R. Population-based study of risk of venous thromboembolism associated with various oral contraceptives. Lancet 1997, 349: 83-8.
53. Lewis, M.A., Heinemann, L.A.J., MacRae, K.D., Bruppacher, R., Spitzer, W.O. The increased risk of venous thromboembolism and the use of third generation progestagens: Role of bias in observational research. Contraception 1996, 54: 5-13.
54. Suissa, S., Biais, L., Spitzer, W.O., Cusson, J., Lewis, M., Heinemann, L. First-time use of newer oral contraceptives and the risk of venous thromboembolism. Contraception 1997, 56: 141-6.
55. Kuhl, H. Effects of progestins on haemostasis. Maturitas 1996, 24: 1-19.
56. Spona, J., Feichtinger, W., Kindermann, C. et al. Double-blind, randomized, placebo-controlled study on the effects of the monophasic oral contraceptive containing 30 μg ethinyl estradiol and 2.00 mg dienogest on the hemostatic system. Contraception 1997, 56: 67-75.
57. Norris, L.A., Bonnar, J. The effect of oestrogen dose and progestin type on haemostatic changes in women taking low dose oral contraceptives. Br J Obstet Gynaecol 1996, 103: 261-7.
58. Winkler, U.H., Schindler, A.E., Endrikat, J., Düsterberg, B. A comparative study of the effects on the hemostatic system of two monophasic gestodene oral contraceptives containing 20 μg and 30 μg ethinylestradiol. Contraception 1996, 53: 75-84.
59. Kluft, C., Lansink, M. Effect of oral contraceptives on haemostasis variables. Thrombos Haemostas 1997, 78: 315-26.
60. Corson, S.L. Contraceptive steroid effects on nonreproductive organ systems. J Reprod Med 1986, 31: 865-78.
61. Weindling, H., Henry, J.B. Laboratory test results altered by "the pill". J Am Med Ass 1974, 229: 1762-8.
62. Masson, S., Franssen, E., Hilditch, J.R., Powell, M.G. A clinical comparison of two triphasic oral contraceptives with levonorgestrel or norethindrone: A prospective, randomized, single-blind study. Contraception 1993, 47: 43-54.