Bleeding Pattern and Cycle Control With Estetrol-Containing Combined Oral Contraceptives: Results From a Phase II, Randomised, Dose-Finding Study (FIESTA)
Reproductive medicine (gynecology, andrology, obstetrics)
Author, co-author :
Apter, Dan
Zimmerman, Yvette
Beekman, Louise
Mawet, Marie ; Université de Liège - ULiège > Doct. sc. bioméd. & pharma. (Bologne)
Maillard, Catherine
Foidart, Jean-Michel ; Université de Liège - ULiège > Département des sciences cliniques > Département des sciences cliniques
Coelingh Bennink, Herjan
Language :
English
Title :
Bleeding Pattern and Cycle Control With Estetrol-Containing Combined Oral Contraceptives: Results From a Phase II, Randomised, Dose-Finding Study (FIESTA)
[4] Stegeman, B.H., de Bastos, M., Rosendaal, F.R., van Hylckama Vlieg, A., Helmerhorst, F.M., Stijnen, T., et al. Different combined oral contraceptives and the risk of venous thrombosis: systematic review and network meta-analysis. BMJ, 347, 2013, f5298.
[5] Rosenberg, M.J., Meyers, A., Roy, V., Efficacy, cycle control, and side effects of low- and lower-dose oral contraceptives: a randomized trial of 20 micrograms and 35 micrograms estrogen preparations. Contraception 60 (1999), 321–329.
[6] Hoffmann, H., Moore, C., Zimmermann, H., Elger, W., Schwarz, S., Graser, T., et al. Approaches to the replacement of ethinylestradiol by natural 17beta-estradiol in combined oral contraceptives. Exp Toxicol Pathol 50 (1998), 458–464.
[7] Mansour, D., Verhoeven, C., Sommer, W., Weisberg, E., Taneepanichskul, S., Melis, G.B., et al. Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17beta-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen. Eur J Contracept Reprod Health Care 16 (2011), 430–443.
[8] Westhoff, C., Kaunitz, A.M., Korver, T., Sommer, W., Bahamondes, L., Darney, P., et al. Efficacy, safety, and tolerability of a monophasic oral contraceptive containing nomegestrol acetate and 17beta-estradiol: a randomized controlled trial. Obstet Gynecol 119 (2012), 989–999.
[9] Ahrendt, H.J., Makalova, D., Parke, S., Mellinger, U., Mansour, D., Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel. Contraception 80 (2009), 436–444.
[10] Fraser, I.S., Jensen, J., Schaefers, M., Mellinger, U., Parke, S., Serrani, M., Normalization of blood loss in women with heavy menstrual bleeding treated with an oral contraceptive containing estradiol valerate/dienogest. Contraception 86 (2012), 96–101.
[11] Holinka, C.F., Diczfalusy, E., Coelingh Bennink, H.J., Estetrol: a unique steroid in human pregnancy. J Steroid Biochem Mol Biol 110 (2008), 138–143.
[12] Hammond, G.L., Hogeveen, K.N., Visser, M., Coelingh Bennink, H.J., Estetrol does not bind sex hormone binding globulin or increase its production by human HepG2 cells. Climacteric 11:Suppl. 1 (2008), 41–46.
[13] Visser, M., Foidart, J.M., Coelingh Bennink, H.J., In vitro effects of estetrol on receptor binding, drug targets and human liver cell metabolism. Climacteric 11:Suppl. 1 (2008), 64–68.
[14] FDA label E2V/DNG. 2012.
[15] Visser, M., Holinka, C.F., Coelingh Bennink, H.J., First human exposure to exogenous single-dose oral estetrol in early postmenopausal women. Climacteric 11:Suppl. 1 (2008), 31–40.
[16] Coelingh Bennink, H.J., Skouby, S., Bouchard, P., Holinka, C.F., Ovulation inhibition by estetrol in an in vivo model. Contraception 77 (2008), 186–190.
[17] Visser, M., Coelingh Bennink, H.J., Clinical applications for estetrol. J Steroid Biochem Mol Biol 114 (2009), 85–89.
[18] Coelingh Bennink, H.J., Holinka, C.F., Diczfalusy, E., Estetrol review: profile and potential clinical applications. Climacteric 11:Suppl. 1 (2008), 47–58.
[19] Duijkers, I.J., Klipping, C., Zimmerman, Y., Appels, N., Jost, M., Maillard, C., et al. Inhibition of ovulation by administration of estetrol in combination with drospirenone or levonorgestrel: Results of a phase II dose-finding pilot study. Eur J Contracept Reprod Health Care 20 (2015), 476–489.
[20] Mawet, M., Maillard, C., Klipping, C., Zimmerman, Y., Foidart, J.M., Coelingh Bennink, H.J., Unique effects on hepatic function, lipid metabolism, bone and growth endocrine parameters of estetrol in combined oral contraceptives. Eur J Contracept Reprod Health Care 20 (2015), 463–475.
[21] World Health Organization, Medical eligibility criteria for contraceptive use. 4th ed., 2009, WHO Press, 15–44.
[22] Roos, J., Johnson, S., Weddell, S., Godehardt, E., Schiffner, J., Freundl, G., et al. Monitoring the menstrual cycle: Comparison of urinary and serum reproductive hormones referenced to true ovulation. Eur J Contracept Reprod Health Care 20 (2015), 438–450.
[23] Mishell, D.R. Jr., Guillebaud, J., Westhoff, C., Nelson, A.L., Kaunitz, A.M., Trussel, J., et al. Recommendations for standardization of data collection and analysis of bleeding in combined hormone contraceptive trials. Contraception 75 (2007), 11–15.
[24] Oddsson, K., Leifels-Fischer, B., Wiel-Masson, D., de Melo, N.R., Benedetto, C., Verhoeven, C.H., et al. Superior cycle control with a contraceptive vaginal ring compared with an oral contraceptive containing 30 microg ethinylestradiol and 150 microg levonorgestrel: a randomized trial. Hum Reprod 20 (2005), 557–562.
[25] Gruber, D.M., Huber, J.C., Melis, G.B., Stagg, C., Parke, S., Marr, J., A comparison of the cycle control, safety, and efficacy profile of a 21-day regimen of ethinylestradiol 20mug and drospirenone 3mg with a 21-day regimen of ethinylestradiol 20mug and desogestrel 150mug. Treat Endocrinol 5 (2006), 115–121.
[26] DelConte, A., Loffer, F., Grubb, G.S., Cycle control with oral contraceptives containing 20 micrograms of ethinyl estradiol. A multicenter, randomized comparison of levonorgestrel/ethinyl estradiol (100 micrograms/20 micrograms) and norethindrone/ethinyl estradiol (1000 micrograms/20 micrograms). Contraception 59 (1999), 187–193.
