[en] To assess the contraceptive reliability, cycle control and tolerability of a new monophasic oral contraceptive containing 30 g ethinylestradiol plus 3 mg drospirenone (Yasmin, Schering AG, Berlin, Germany), it was compared with an established oral contraceptive containing 30 g ethinylestradiol plus 150 g desogestrel (Marvelon, NV Organon, Oss, The Netherlands).
METHODS:
A randomized, open-label, 13-cycle study was performed at 80 European centers. Contraceptive reliability, cycle control, blood pressure, body weight, the incidence of adverse events and skin condition were assessed during 13 cycles of oral contraceptive use, and at follow-up. Subjects recorded body weight on three consecutive days pretreatment and weekly thereafter.
RESULTS:
Of 2069 women who started the study and received the trial preparations in a ratio of 4:1 (ethinylestradiol/drospirenone, n = 1657; ethinylestradiol/desogestrel, n = 412), 1615 completed the 13 cycles plus follow-up, providing data for over 23,000 evaluable cycles. Eleven pregnancies occurred during treatment, only one of which (in the ethinylestradiol/drospirenone group) could not be ascribed to user failure or interaction with other factors. Both preparations provided effective contraception and cycle control. Pre-existing acne and seborrhea were improved and blood pressure was essentially unchanged. The two treatments differed in their effect on body weight, the difference being statistically significant. In the ethinylestradiol/drospirenone group, there was a distinct decrease over the whole treatment phase, while a subtle and less distinct decrease was documented in the ethinylestradiol/desogestrel group.
CONCLUSIONS:
The combination of 30 g ethinylestradiol/3 mg drospirenone provides effective oral contraception, excellent cycle control, good tolerability and a level of weight loss that may have a significant beneficial effect on compliance in women with a tendency to weight gain due to water retention.
Disciplines :
Reproductive medicine (gynecology, andrology, obstetrics)
Author, co-author :
Huber, J.
Foidart, Jean-Michel ; Université de Liège - ULiège > Département des sciences cliniques > Gynécologie - Obstétrique
Wuttke, W.
Merki-Feld, G. S.
The, H. S.
Gerlinger, C.
Schellschmidt, I.
Heithecker, R.
Language :
English
Title :
Efficacy and tolerability of a monophasic oral contraceptive containing ethinylestradiol and drospirenone.
Publication date :
2000
Journal title :
European Journal of Contraception and Reproductive Health Care
ISSN :
1362-5187
eISSN :
1473-0782
Publisher :
Parthenon Publishing Group, Carnforth, United Kingdom
1. Rosenberg M. Oral contraceptive discontinuation: a prospective evaluation of frequency and reasons. Am J Obstet Gynecol 1998;179:577-82
2. Woods ER, Grace E. Havens KK, et al. Contraceptive compliance with a levonorgestrel triphasic and a norethindrone monophasic oral contraceptive in adolescent patients. Am J Obstet Gynecol 1992;166:901-7
3. Muhn P, Krattenmacher R, Beier S, et al. Drospirenone, a novel progestogen with antimineralocorticoid and antiandrogenic activity. Contraception 1995;51:99-110
4. Fuhrmann U, Krattenmacher R, Slater EP, et al. The novel progestin drospirenone and its natural counterpart progesterone: biochemical profile and antiandrogenic potential. Contraception 1996;54:243-51
5. Oelkers W, Berger V, Bolik A, et al. Dihydrospirorenone, a new progestogen with antimineralocorticoid activity: effects on ovulation, electrolyte excretion, and the renin-aldosterone system in normal women. J Clin Endocrinol Metab 1991;73:837-42
6. Oelkers W, Foidart JM, Dombrovicz N, et al. Effects of a new oral contraceptive containing an antimineralocorticoid progestogen, drospirenone, on the renin-aldosterone system, body weight, blood pressure, glucose tolerance, and lipid metabolism. J Clin Endocrinol Metab 1995;80:1816-21
7. Rosenbaum P, Schmidt W, Helmerhorst FM, et al. Inhibition of ovulation by a novel progestogen (drospirenone) alone or in combination with ethinylestradiol. Eur J Contracept Reprod Health Care 2000;5:16-24
8. Burke BM, Cunliffe WJ. The assessment of acne vulgaris -the Leeds technique. Br J Dermatol 1984;111:83-92
9. Oddens BJ. Women's satisfaction with birth control: a population survey of physical and psychological effects of oral contraceptives, intrauterine devices, condoms, natural family planning and sterilization among 1466 women. Contraception 1999;59:277-86